A mixture of: N,N-diethylpropane-1,3-diamine 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2,2-iminodiethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2-methylaminoethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate

Endpoint summary

Description of key information

Valid GLP studies are available for the irritation potential of the test article on the skin and in the eye.
The skin irritating potential was assessed in a study conducted according to the OECD TG 404 (RCC 205547); the test article was not irritating to the skin of rabbits tested under semi-occlusive conditions.
The eye irritating potential  was assessed in a study conducted according to the OECD TG 405 (RCC 205536); some signs of irritation were observed in all 3 test animals, but complete reversibility was reached after 21 days. Nevertheless, the scoring as calculated according to current criteria resulted in the designation of the test item as not irritating. 
No data are available referring to respiratory irritation.

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

An OECD 404 study was conducted to assess the skin irritating potential of the test article when applied during 4 hours to the skin of rabbit under semi-occlusive conditions (RCC 205547). Skin reading time points after ending of the treatment were 1 h, 24 h, 48 h and 72 h.

None of the 3 test animals (one male and 2 female rabbits) displayed erythema and/or edema. Each of them however, showed a yellow to orange staining of the treated skin, which was seen at all reading time points. Thus, it can be concluded that the test article was not irritating to the skin of rabbit under the test conditions used.

The eye irritation potential of the test article was assessed in a study conducted according to the OECD TG 405 (RCC 205536). For this purpose, an amount of 0.1 g unchanged test article was placed in the conjunctival sac of one eye of the test animal; 3 rabbits were used, and the untreated eye served as control. The test article was not washed out and the treated eyes were examined at defined reading time points after 1, 24, 48 and 72 h following treatment, and further after 7, 14 and 21 days. The eye findings were evaluated using the Draize numerical scoring system as recommended by the OECD guideline.

In animal 1, corneal opacity graded 1 was seen at reading time point (RTP) 72 h, 7 d and 14 d; conjunctival redness graded 2 was seen at RTP 1, 24, 48 and 72 h, and had turned slight (grade 1) on 7d; thereafter no redness was evident; chemosis was graded 2 at RTP 1 h and 1 thereafter, at RTP 24, 48 and 72 h. The iris was inconspicuous. Discharge reaching from severe to slight was observed until RTP 14 d whereas an orange discoloration of the eye lasted until RTP 7 days. Complete reversibility of all findings was attained after 21 days.

In animal 2, corneal opacity graded 1 was seen at reading time point (RTP) 24 h, 48 h, 72 h, 7 d and 14 d; conjunctival redness graded 2 was seen at RTP 1, 24, 48 h, and had turned slight (grade 1) at 72 h; thereafter no redness was evident; chemosis was graded 2 at RTP 1 h and 1 thereafter, at RTP 24 and 48 h. The iris was inconspicuous. Discharge reaching from severe to slight was observed until RTP 48 h whereas an orange discoloration of the eye lasted until RTP 7 days. Complete reversibility of all findings was attained after 21 days.

In animal 3, corneal opacity graded 1 was seen at reading time point (RTP) 72 h and 7 d; conjunctival redness graded 2 was seen at RTP 1, 24, 48 h, and had turned slight (grade 1) at 72 h; thereafter no redness was evident; chemosis was graded 2 at RTP 1 h and 1 thereafter, at RTP 24 and 48 h. The iris was inconspicuous. Discharge reaching from severe to slight was observed until RTP 48 h whereas an orange discoloration of the eye lasted until RTP 7 days. Complete reversibility of all findings was attained after 14 days.

The mean scores for the RTP 24, 48 and 72 h were calculated for the respective animals and were as follows:

- Corneal opacity (animal 1, 2 and 3): 0.3, 1, 0.3

- Iris (animal 1, 2 and 3): 0, 0, 0

- Conjunctival redness (animal 1, 2, 3): 2, 1.7, 1.7

- Chemosis (animal 1, 2, 3): 1, 0.7, 0.7

Thus, despite of some signs of eye irritation, the mean score values are insufficient for designation of the test article as irritant.

Justification for classification or non-classification

Validated data are available for both, skin and eye irritation. For the skin, no signs of irritation were seen, thus classification of the test article for skin irritation according to the EU Directive 67/548/EEC and to the CLP Regulation (EC) 1272/2008 is not needed.

For the eye, some signs of eye irritation were obvious in all 3 animals tested, which however were fully reversible. Despite of the findings, the mean score values for corneal opacity, iritis, conjunctiva redness and chemosis at the relevant reading time points 24, 48 and 72 h as calculated according to current recommendations, do not allow classification of the test item as an irritant according to the EU Directive 67/548/EEC and to the CLP Regulation (EC)/1272/2008, respectively.

Thus, no classification is needed for both, skin and eye irritation, according to the EU Directive 67/548/EEC and to the CLP Regulation (EC)/1272/2008.