Primary eye irritation test

Borg-Warner Chemicals EYI-OTS-0785-0422 ELWP. Sequence D. Primary Eye Irritation Tests of Triphenyl Phosphite in Rabbits. Washington, DC, US Environmental Protection Agency, Office of Taxic Substances, 1980... 

Fujii T, Sakamoto Y, Fukumori N, et al. 1976. [Primary eye irritation tests using a chromium dross extract]. Annual Report of the Tokyo Metropolitan Research Faboratory of Public Health 27 124-128. (Japanese). 

The primary eye irritation test was originally intended to predict the potential for a single splash of chemical into the eye of a human being to cause reversible or permanent damage. The common core design of the test, as currently utilized, consists of instilling either 0.1 ml of a liquid or 0.1 g of a powder (or other solid) into one eye of each of six rabbits. The material is not washed out, and both eyes of each animal (the untreated eye acting as a control)... 

WJW, Roddy M, Schnetzinger R, Silber PM, Glaza SM, Kurtz PI (1991) The CTFA evaluation of alternatives program an evaluation of in vitro alternatives to the Draize primary eye irritation test (phase 1) hydro-alcoholic formulations (part 2) data analysis and biological significance. In Vitro Toxicol 4 247-288... 

Primary Irritancy Studies. These studies are employed to determine the potential of materials to cause local inflammatory effects in exposed body surfaces, notably skin and eye, following acute or short-term repeated exposure. In general, the approach involves applying the test material to the surface of the skin or eye, and observing for signs of inflammation, their duration, and resolution. Reviews have been written about the conduct of primary eye irritation (58,86,87) and primary skin irritation studies (88,89). 

Primary eye irritation- rabbits as test animals - new in vitro cell testing... 

Although the correlation between low pHs (acids) and eye damage in the rabbit has not been found to be excellent, all alkalis (pH 11.5 or above) tested have been reported to produce opacities and ocular damage. Many laboratories now use pH cutoffs for testing of 2.0 or lower and 11.5 or 12.0 and higher. If a material falls outside these cutoffs (or is so identified due to other physicochemical parameters), then it is (1) not tested in the rabbit eye and is assumed to be corrosive (2) evaluated in a secondary screen such as an in vitro cytotoxicity test or primary dermal irritation test or (3) evaluated in a single rabbit before a full-scale eye irritation test is performed. It should be kept in mind that the correlation of all the... 

PBO was tested in both primary eye irritation and skin irritation studies in rabbits, dogs and cals. In all such studies, the compound was found to have minimal or no irritating effects. Sensitization studies performed on guinea pigs and rabbits (dermal exposure showed that PBO was not a sensitizing agent. 

Primary Irritation. Dispersed as smoke, aerosol, or in solution, agents will contaminate skin and eyes and may cause acute inflammatory reactions at these sites. Therefore, there is a requirement to know if contact with the skin and eye will have a local tissue injuring potential and how formulation may affect the reaction. Supplemental to standard eye irritation tests it is of practical value to undertake in vivo studies on the influence of the agent on corneal thickness by pachymetry and on lOP by tonometry (Ballantyne et al., 1977a Myers et al., 1998 Ballantyne, 1999b). 

Primary skin and eye irritation tests in rabbits indicated that an Indian frankincense extract containing 30% 3-O-acetyl-11-keto-P-boswellic acid was nonirritating to the skin and mildly irritating to the eyes (Lalithakumari et al. 2006). 

Because the respiratory tract is an initial target of any air pollutant challenge, it usually receives primary attention in tests to determine irritant effects of exposure. Other aspects of interest include hematology, blood enzyme biochemistry, eye irritation, and p chomotor performance. Constriction of the large airways, maldistribution of ventilation due to narrowing in some small airways, constriction of peripheral lung units, and mechanical or gas diffusion impairment due to edema are possible effects of insult by pollutants. A variety of pulmonary tests is required to examine the possibilities. 

CTFA Submission of Data by CTFA. CIR Safety Data Test Summary, Primary Skin Irritation and Eye Irritation of Triethanolamine, 1959... 

In primary irritation tests no or only slight effects were seen at the skin or in the eyes of the treated rabbits respectively [3.213], [3.214], No skin sensitisation occurred in a Guinea pig maximisation test [3.211]. 

Ellis HV, Hodgson JR, Hwang SW, et al. 1978. Mammalian toxicity of munitions compounds. Phase I Acute oral toxicity, primary skin and eye irritation, dermal sensitization, disposition and metabolism and Ames tests of additional compounds. NTIS/AD-A069 333. [Unpublished study to be peer-reviewed],... 

The test substance will not be studied for eye irritation if it is a strong acid (pH of 2.0 or less) or strong alkali (pH of 11.0 or greater) and/or if the test substance is a severe dermal irritant (with a primary dermal irritation index (PDll) of 5-8) or causes corrosion of the skin. 

The Federal Flazardous Substances Acts (FHSA) of 1940 and of 1960 define five areas of acute toxicity/irritation that are of primary importance for the development and sale of consumer products acute oral toxicity, dermal toxicity, primary dermal irritation, eye irritation, and acute inhalation toxicity. The FHSA act describes recommended test conditions in detail for these toxicity/irritation phenomena. Some knowledge of the potential for sensitization and phototoxicity are also relevant, and to provide longterm safety assurance, potential carcinogenicity and mutagenicity must also be considered. 

IPBC is not a primary skin irritant, but is irritant and corrosive to the eyes. No skin sensitization effects were observed in the guinea pig maximization test. Ames test and micronucleus assay did not show signs of mutagenicity. 

Biocompatibility, especially safety and mildness to skin, are very important properties of interest for the application of AAS. Animal tests such as the Draise method for primary eye and skin irritation and the maximization test for sensitization have been widely used in the past. Recently, an alternative or in vitro test was actively developed for the purpose of refining, reducing, and replacing the animal test. Although there are still no perfect alternatives... 

Melamine ia a skin test on rabbits produced neither local irritation nor systemic toxicity. As a 10% solution ia methylceUulose, it caused no irritation ia the eyes of rabbits. Human subjects were given patch tests with melamine. No evidence of either primary irritation or sensitization was found. Such results suggest that melamine crystal may be handled ia ordinary iadustrial use without special hygienic precautions. 

---