Sodium bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)

Endpoint summary

Description of key information

The test article was not irritating to the skin or the eye when tested in rabbits.

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)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

A non-GLP study was conducted in order to test the primary cutaneous irritation of the test substance on six male New Zealand white rabbits. Although no OECD guidelines were used, the study was scientifically acceptable ("Draize test" performed according Fed. Reg. 38, No. 187, § 1500.41, 1973). In the study the test substance was applied at a rate of 0.5 mL per area/animal (viscous compound) and at 0.5 g per area/animal (powdery/pasty material) to the right, previously scarified flank and the left intact flank of the rabbits. After application the rabbits were observed over a period time of 7 days. Recording of the observations of erythema and oedema was started after an exposure time of 24 hours (observation times: 25 and 72 hours as well as 7 days after application). No edema was observed on the intact skin of any of the tested animals. Slight erythema was observed in three animals with scores of 0.5 to 1 which had resolved by the end of the study period (7 days). Based on these results the substance is not regarded as skin irritating.

 

Eye irritation

A non-GLP study was conducted to test the ocular irritation of the test substance on six male New Zealand white rabbits. Although no OECD guidelines were used, the study was scientifically acceptable ("Draizetest" performed according to Fed. Reg. 38, No. 187, § 1500.41). In the study 100 mg of the test substance was introduced into the conjunctival sac of the right eye of each rabbit. The left eyes served as a control, respectively. The eye lids were held closed for several seconds, moved gently up and down, by avoiding loss of the substance. After application the animals were kept restrained for 18 hours and then placed in their cages. The observed effects on conjunctiva, iris and cornea were recorded at 1 and 24 hours after application, as well as 2, 3, 4 and 7 days after administration. Mean scores of effects were calculated based on 24, 48 and 72 hour findings of each animal. A slight irritation was visible at iris (2/6 animals) and conjunctivae (chemosis 4/6 animals) 24 hours after application, which was fully reversible until day 3 of the test (scores of 0.33 to 0.67 were observed). Conjunctival redness was observed in 4 out 6 animals after 24 hours (a score of 0.33 was observed). Redness had fully resolved after 72 hours. The cornea of the rabbit eyes was not affected in any of the test animals. The mean index of Ocular Irritation showed a score of 5.0 (non-irritant). Based on these findings the test substance is not regarded as irritating to the eyes.  

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008  

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified as eye or skin irritating under Regulation (EC) No 1272/2008.