Chromate(2-), [3-[4,5-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonato(3-)][2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]-, sodium

Endpoint summary

Description of key information

not skin irritant

not eye irritant

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

One in vivo study (Huntsman 1975) was performed on analogue substance 2 following OECD 404, to assess skin irritation in rabbits. Under the experimental conditions the substance showed a maxium score equal to zero.

Another in-vitro study (Huntsman, 2015, Episkin) was performed on analogue substance 1 following OECD 439. Under the experimental conditions the substance showed a relative mean viability equal to 62.8.

Based on the read across considerations same results can apply to Acid Orange 144.

 

Eye irritation

 

Eye Irritation/corrosion:

The Bovine Corneal Opacity and Permeability (BCOP) test was performed on analogue substance 1 according to GLP and according to OECD guideline 437 (Huntsman, 2015). The test item was applied at a concentration of 20 % w/v in 0.9% w/v sodium chloride solution for 240 minutes. Negative and positive control items were tested concurrently. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS). After 240 minutes of test substance application, In Vitro Irritancy Score (IVIS) of 38.1 was observed, indicating that no prediction of eye irritation can be made.

 

Another study was performed as prescribed by The Food and Drug Administration of the U.S.A. in The Federal Register (17 September 1964 * 191.12) exposing six rabbit eye to analogue substance 1 and observed for 7 days. The ocular reactions were scored by the method described by J. H. Draize in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" p 51. Two animals showed temporary corneal opacities and mild conjunctival reactions were observed in the four remaining animals, but the overall irritation score resulted equal to zero over a time point of 21 days.. Based on the results FAT 20010/A is considered to be "minimally irritant" to the rabbit eye.

Based on the read across considerations same results apply to Acid Orange 144.

Justification for classification or non-classification

According to Regulation 1272/2008, a substance is classified as:

Skin irritant cat2:

1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

2)Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or

3) in some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

Based on the above results Acid Orange 144 is not classified as skin irritant

 

A substance is classified as:

Eye irritant Cat 2 if in at least in 2 of 3 tested animals, a positive response of:

1)     corneal opacity ≥ 1 and/or

2)     iritis ≥ 1, and/or

3)      conjunctival redness ≥ 2 and/or

4)      conjunctival oedema (chemosis) ≥ 2

 calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days

Based on the above results Acid Orange 144 is not classified as eye irritant.