3,3'-[(4-{(E)-[2-bromo-4-nitro-6-(trifluoromethyl)phenyl]diazenyl}phenyl)imino]dipropanenitrile

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Additional information:

There were two studies conducted to assess the possible cutaneous allergenic potential of FAT41'029/A, including Maximization-Test (RCC Project Number 756415) and Bühler Test” (RCC Project Number 764897).

The GMPT was performed in the nuchal region with dilution of the test article in PEG 300 and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline, in accordance with OECD Guideline No.406.

No toxic symptoms were evident in the guinea pigs of the control or test group. No deaths occurred. Six out of 10 test animals showed discrete/patchy to moderate/confluent erythema at the 24-hour reading and five out of 10 test animals showed discrete/patchy erythema at the 48-hour reading after the challenge treatment with FAT41'029/A at 25 % (w/w) in PEG 300. No skin effect was observed in the control group. In this study, FAT41029/A is classified as a skin sensitizer based on the above mentioned findings in an adjuvant sensitization test in guinea pigs.

However, another supportive study - “Bühler Test” gave a negative result. In this test, twenty male animals of the test group were treated topically with FAT41029/A at 50 % in polyethylene glycol (PEG 300) once a week for a 6-hour exposure period in a 3-week induction phase. Two weeks after the final induction application the animals were challenged with the same test article concentration of 50 % in PEG 300 as used for induction. The ten animals of the control group were not treated during the induction. They were treated once at challenge with FAT 41’029/A at 50 % in PEG 300. None of the control and test animals were observed with skin reactions after the challenge treatment with the highest non-irritating concentration of FAT41'029/A at 50 % in PEG 300.

Therefore, in this non-adjuvant sensitization test in guinea pigs, FAT 41’029/A applied at a concentration of 50 % in PEG 300 is not classified as a skin sensitizer.

GMPT is more sensitive than the BT test to detect a possible allergenic potential of test items. But BT test is an appropriate method for detecting the strong sensitizer. Therefore, based on the above mentioned finding, FAT 41029/A was concluded to be a skin sensitizer.

Migrated from Short description of key information:
FAT 41029/A is considered as a skin sensitizer based on the available data.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

Migrated from Short description of key information:
Data on respiratory sensitisation are not available.

Justification for classification or non-classification

Based on the available data, the test item is considered as a skin sensitizer. Therefore, FAT 41029/A shall be classified as skin sensitizer category 1B according to CLP regulation EC No. 1272/2008, respectively as Xi, R43 according to DSD (Directive 67/548/EEC).