Registration Dossier

Administrative data

Description of key information

Not irritating on rabbit skin (OECD 404)

Not irritating in rabbit eyes (OECD 405, OECD 437, OECD 492)

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:
Reliable data from two studies on skin irritation are available for the test substance. These data reveal a very low skin irritation potential for the 'yellow disazo condensation pigment'.
In a primary dermal OECD guideline irritation study (OECD 404, Ciba-Geigy Ltd., 1983), 3 female New Zealand White rabbits were dermally exposed to 0.5 g of the test substance (CAS 5280-80-8) for 4 hours under semiocclusive conditions. Animals then were observed for 7 days. Irritation was scored by the method of Draize as described in the OECD guideline 404. The mean score for the 24, 48 and 72 h reading for erythema was 0.44 and for edema was 0. The skin reactions observed were fully reversible within 48 hours. Under the conditions of the present experiment the test substance was found to be non-irritant and not corrosive when applied to the rabbit skin (BASF, 1983).
In a supporting study 3 male and 3 female New Zealand White rabbits were dermally exposed to 0.5 g of the test substance for 24 h under occlusive conditions. After 24 and 72 hours the application sites were assessed for oedema and erythema. Under the conditions of this test, the pigment was also not considered to be irritating to the rabbit skin (Ciba-Geigy Ltd., 1975).
 
Eye:
Reliable data from two in vitro and two in vivo studies on eye irritation are available for the test substance.

For the test substance a Bovine Corneal Opacity and Permeability Test (BCOP Test) according to OECD guideline 437 were conducted (BASF, 2015). Three corneas were treated with the undiluted test substance (bulk volume of about 45 mg) for an exposure period of 4 hours. Based on the observed results (IVIS score = 0.0) it was concluded, that the test substance does not cause ocular corrosion or severe irritation in the Bovine Corneal Opacity and Permeability Test (BCOP Test). However, the Guideline also states, that due to limited accuracy of the BCOP test to correctly identify substances that do not require classification for eye irritation or serious eye damage, this test method should not be the first choice to initiate a bottom-up approach. Thus, the substance was also examined in an EpiOcular to exclude an eye irritation potential.
The conducted EpiOcular™ Eye irritation study with the test substance was performed according to OECD guideline 492 (BASF, 2015). The tissue was treated with 50 µL bulk volume (about 9 g) of the test substance for 6 hours followed by a 18-hours post-incubation period. The determined mean relative tissue viability compared to the negative control is 91.2 %. Since the mean tissue viability was >60 % of the negative control, the test substance does not show any eye irritation potential in the EpiOcular™ eye irritation test.

Further, two in vivo eye irritation test with New Zealand White rabbits according to OECD 405 are available. In one test (Ciba-Geigy Ltd., 1983) the eyes were left unwashed after application of 0.1 g of test substance and the animals were observed 7 days. The mean scores for the 24, 48 and 72 h reading for conjunctivae redness, iritis, cornea opacity and conjunctivae chemosis were 0.1, 0, 0.1, and 0, respectively. After 48 hours all reactions were reversed. In the other test (Ciba-Geigy Ltd., 1975) three animals eyes were left unwashed and three animals the eyes were washed out after 30 seconds after application of 0.1 g of test substance and the animals were observed 72 hours. The mean scores for the 24, 48 and 72 h reading for conjunctivae redness, iritis, cornea opacity and conjunctivae chemosis were 0 at any reading time point. Conjunctival redness was only observed after 1 hour after application.

Based on the results of the in vitro and in vivo tests with the test substance it is concluded that the pigment is not irritating to the eye.

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. Based on available data on skin irritation/corrosion and eye irritation, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.