1,4-Benzenedisulfonic acid, 2,2'-[1,2-ethenediylbis[(3-sulfo-4,1-phenylene)imino[6-[bis(2-hydroxypropyl)amino]-1,3,5-triazine-4,2-diyl]imino]]bis-, sodium salt (1:6)

Endpoint summary

Description of key information

Category assessment used to read across:
Not irritating on rabbit skin (OECD 404)
Not irritating in rabbit eyes (OECD 405)

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:

In a primary dermal irritation study with of CAS 16090 -02 -1 (CIBA-Geigy Ltd 1982), 6 New Zealand White rabbits were dermally exposed to 0.5 mL of test substance for 24 hours under occlusive 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 1.4 and for edema was 0.4. The skin reactions observed were fully reversible until the end of the observation period on day 7. In this study, the category member (CAS 16090-02-1) is not a dermal irritant. This result is supported by another similar study on this substance (CIBA-Geigy Ltd, Basel, Switzerland 1975d).

In a further primary dermal irritation study (CIBA-Geigy Ltd 1975), 6 rabbits of the Russian breed were dermally exposed to 0.5 mg of the test substance for 24 hours under occlusive conditions. Animals then were observed for 3 days. Irritation was scored by the method of Draize as described in the OECD guideline 404. The mean score for the 24 and 72 h reading for erythema was 0.3 and for edema was 0.2. The skin reactions observed were reversible until the end of the observation period on day 3. In this study, the category member (CAS 13863-31-5) is not a dermal irritant. In a supportive study done in the same way comparable results were obtained (CIBA-GEIGY Limited, Basel, Switzerland (1976b).

In a another primary dermal irritation study (Lab. für Pharma&Toxikologie, Hamburg 1979), 6 female and male New Zealand White rabbits were dermally exposed to 0.5 mg of the test substance for 24 hours under occlusive conditions. Animals were observed for 14 days. Irritation was scored by the method of Draize. The mean score for the 24, 48 and 72 h reading for erythema and edema was 0, respectively. In this study, the category member (70942-01-7) is not a dermal irritant.

In a further primary dermal irritation study (OECD 404, CIBA-Geigy Ltd, Basel, Switzerland 1987), 3 male New Zealand White rabbits were dermally exposed to 0.5 mg test substance for 4 hours under occlusive conditions. Animals then were observed for 3 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 and edema was 0. In this study, the category member (CAS 4193-55-9) is not a dermal irritant.

In a primary dermal irritation study (Sandoz AG, Basle, Switzerland 1975), 6 rabbits were dermally exposed to 0.5 mg of the test substance for 24 hours under occlusive conditions. Animals then were observed for 3 days. Irritation was scored by the method of Draize. The mean score for the 24 and 72 h reading for erythema and edema was 0.5, respectively. The skin reactions observed were reversible until the end of the observation period on day 3. In this study, the category member (CAS 27344-06-5) is not a dermal irritant.

In a primary dermal irritation study (CIBA-Geigy Ltd 1981), 3 female and 3 male New Zealand White rabbits were dermally exposed to 0.5 g of the test substance diluted in polyethylen glykol and saline for 24 hours under occlusive conditions. Animals then were observed for 7 days. Irritation was scored by the method of Draize. The mean score for the 24, 48 and 72 h reading for erythema was 0.8 and for edema 0.4. The skin reactions observed were reversible within 7 days (erythema) and 72 hours (edema), respectively. In this study, the category member (CAS 16470-24-9) is not a dermal irritant.

In a primary dermal irritation study (similar to OECD 404, CIBA 1988), 3 male New Zealand White rabbits were dermally exposed to 0.5 mg of the test substance for 4 hours under occlusive conditions. Animals then were observed for 3 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 0.1 and for edema was 0. The skin reactions observed were fully reversible until the end of the observation period on day 3. In this study, the category member (41098-56-0) is not a dermal irritant.

No reliable study on skin irritation of the other category members are available. But due to the consistent observation that the other

Stilbene fluorescent whitening agents do not induce skin irritation it is concluded that these members are also not irritating to skin. In summary, it is concluded that Stilbene fluorescent whitening agents of this category and then, reading across, also the substance CAS 371756 -75 -1, are not irritating to skin and have not to be classified as skin irritants.

Eye:

An eye irritation test was performed with three New Zealand White rabbits (CIBA-Geigy Ltd 1982). Eyes were left unwashed after application of 0.1 g test substance and the animals were observed 7 days. The mean scores for the 24, 48 and 72 h reading for iritis and cornea opacity were 0 at any reading time point. For conjunctivae redness the mean score was 0.3 and for conjunctivae chemosis 0.1. The eye reactions observed were fully reversible within 72 and 48 hours, respectively. In this study the category member (CAS 16090-02-1) is not an eye irritant. This result is supported by another similar study (Ciba-Geigy 1975).

An eye irritation test was performed with three female and three male New Zealand White rabbits similar to OECD 405 (Lab. für Pharma&Toxikologie, Hamburg 1979). Eyes were left unwashed after application of 0.1 g 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 at any reading time point. In this study the category member (CAS 70942-01-7) is not an eye irritant.

An eye irritation test was performed with six rabbits ( Sandoz AG, Basle, Switzerland 1975). Eyes were left unwashed after application of 44 g test substance and the animals were observed 7 days. The mean scores for the 24, 48 and 72 h reading for conjunctivae redness was 0.3, for iritis and conjunctivae chemosis 0 and for cornea opacity 0.3. The erythema was fully reversible within 7 days and the corneal opacity was reversible within 48 hours. In this study, the category member (CAS 27344-06-5) is not an eye irritant.

An eye irritation test was performed with three female and three male New Zealand White rabbits (CIBA-Geigy Ltd 1981). Eyes were left unwashed after application of 0.1 g test substance and the animals were observed 7 days. The mean scores for the 24, 48 and 72 h reading for iritis, cornea opacity and conjunctivae chemosis were 0 at any reading time point. The mean score for the 24, 48, and 72 h reading for conjunctivae redness was 0.2 and was fully reversible within 48 hours. In this study the category member (CAS 16470-24-9) is not irritating to the eye.

An eye irritation test with one category member (CAS 4193-55-9) was performed with three female New Zealand White rabbits according to OECD 405 ( CIBA-GEIGY Ltd, Basel Switzerland 1987). Eyes were left unwashed after application of 0.1 mL (69 mg) of the 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 1.3, 0.1, 1.0, and 1.3, respectively. These reactions were all fully reversible within 7 days. Only the corneal opacity with a mean score of 1.0 would lead to a classification. Since this score for corneal opacity is borderline, the scores for iritis and conjunctivae redness and chemosis do not lead to classification, all reactions are fully reversible within 7 days and four other substances from this stilbene fluorescent whitening agents category show all negative result it is assumed that this barely positive result is an outlier. Especially looking at the category member (CAS 70942 -01 -7), the substance which differs only in a potassium ion from the test substance: the mean scores for the 24, 48, and 72 hour reading for conjunctivae redness, iritis, cornea opacity and conjunctivae chemosis were 0 at any reading time point. Taking together, the result found in the study from the category member (CAS 4193-55-9) can be regarded as outlier because the score for corneal opacity is boderline and four studies from substances which are structurally very similar to the test substance showed clear negative results. Therefore, this test substance is considered to be not irritant to eye.

No reliable study on eye irritation of the other category members are available. But due to the consistent observation that the other

Stilbene fluorescent whitening agents do not induce eye irritation it is concluded that these members are also not irritating to eye. In summary, it is concluded that Stilbene fluorescent whitening agents of this category and then, reading across, also the substance CAS 371756 -75 -1, are not irritating to eye and have not to be classified as eye irritants.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the category members are not considered to be classified for skin and eye irritation/corrosion under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

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

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the category members are not considered to be classified for skin and eye irritation/corrosion under Regulation (EC) No. 1272/2008.