2-(4-amino-2-nitroanilino)ethanol

Endpoint summary

Description of key information

Based on the results of the key study (Prinsen, 2016, Klimisch 1, GLP, OECD 438 Guideline), the test article HC Red No.3 was Not Classified for Eye Irritation.

Taking into account all the studies klimisch 3 and 4 available and the two key studies (Klimisch 1). The test article HC Red No.3 was Not Classified for Skin Irritation.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

SKIN IRRITATION

Two in vitro method studies (Warren, Klimisch 1, 2017, GLP and OECD 431 & 139 method) were available:

- Based on the results of the corrosion test,  the test item HC Red No. 3 did not led to skin corrosion when applied pure on Reconstructed Human Epidermis EpiDermTM (Viablility at 3 minutes : 97.9 ; at 60 minutes 158.5). Hence, the substance cannot be classififed and was only considered to be not corrosive. According to OECD 431 method, a further study was performed in order to assess the potential skin irritation of the test item

-Triplicate tissues (EpiSkinTM) were treated with the test item for an exposure period of 15 minutes.  At the end of the exposure period each tissue was rinsed before incubating for 42 hours.  The test item was found to have the potential to cause color interference and therefore additional tissues were incorporated for color correction purposes.  At the end of the post exposure incubation period each tissue was taken for MTT-loading in order the quantify the cellular viability. In this test system, the registered substance HC Red No.3 did not induced skin irritation The relative mean viability of the test item treated tissues was 86.1% after the 15 Minute exposure period and 42 Hours post exposure incubation period. Hence, according to CLP criteria, the HC Red No.3 was Not Classified for Skin Irritation.

Considering data available on the two studies of Sterner 1983, and Rodriguez 1983, coted as klimish 3, the test susbstance was considered as not irritant for the skin when tested at 3%. In the study of Rodriguez, 1987, due to lack of information, the cotasion applied was klimisch 4. Regarding the results of the study, the study method followed was probably draize method. The results indicated no irritant effect. All the studies available and their results, the test substance is not irritant for the skin. Additionnaly, in the skin sensitzation studies, no irritant effects had been reported.

EYE IRRITATION

-An Isolated Chicken Eye test was performed (Prinsen, 2016, Klimisch 1, GLP, OECD 438 Guideline) and was considered as Key Study :

HC Red No. 3 was evaluated neat for eye irritation potential in the Isolated Chicken Eye (ICE) test. Chicken eyes were obtained from slaughter animals used for human consumption. The isolated chicken eyes were exposed to a single application of 30 mg for 10 seconds followed by a 20 mL saline rinse. Three main parameters were measured to disclose possible adverse eye effects: corneal thickness (expressed as corneal swelling), corneal opacity and fluorescein retention of damaged epithelial cells. In addition, histopathology of the corneas was performed. HC Red No. 3 caused corneal effects consisting of very slight corneal swelling (mean swelling 4%), no or very slight corneal opacity (mean score 0.2) and no or very slight fluorescein retention (mean score 0.2). Microscopic examination of the corneas did not reveal any abnormalities, other than very slight erosion of the epithelium in one cornea.

Justification for classification or non-classification

Based on the results of the key study (Prinsen, 2016, Klimisch 1, GLP, OECD 438 Guideline) and according to CLP criteria, the test article HC Red No.3 was Not Classified for Eye Irritation.

A weight of evidence approach was done for the skin irritation, taking into account all teh studies klimisch 3 and 4 available. The test article HC Red No.3 was Not Classified for Eye Irritation.

Taking into account all the studies klimisch 3 and 4 available and the two key studies (Warren, Klimisch 1, 2017, GLP, OECD guideline 431 and 439 methods). The test article HC Red No.3 was Not Classified for Skin Irritation.