2-[2-[4-(dimethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium acetate

Endpoint summary

Description of key information

According to column 2 (section 8.1) of REACH Regulation Annex VII and due to animal welfare reasons the study for skin irritation and eye irritation can be waived as the test item causes severe skin burns and is classified as Skin Corr. 1B; H314.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin corrosion: in vitro / ex vivo

Data waiving:

other justification

Justification for data waiving:

the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

other justification

Justification for data waiving:

the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The registered substance contains ca. 33% (w/w) free acetic acid. Acetic acid (CAS 64-19-7) is classified as corrosive to skin according to Annex VI of Regulation (EC) No 1272/2008 (Skin Corr. 1A; H314). Taking into account the specific concentration limits for acetic acid, the registered substance needs to be classified as Skin Corr. 1B; H314 (SCL: 25% ≤ C < 90%). According to column 2 (section 8.1) of REACH Regulation Annex VII studies for skin and eye irritation can be waived as the test item is assessed to be corrosive to the skin.

Already existing studies are available where the registered substance was tested in a composition of 24 % active ingredient, 20 % acetic acid. The free acid content in these studies is lower than the free acid in the composition of the registered substance. Therefore, the results from these studies are not representative for the assessment of this endpoint.

Skin irritation

BASF SE 1978 (77/126)

4 males and 2 females received the test item unchanged in a mixture of 24 % active substance and 20 % acetic acid. Irritation scores were measured after 24, 72 hours and 8 days. The erythema index could not be read and calculated exactly due to substance-induced coloration of the skin. The edema score (mean score after 24 and 72 h) was calculated to be 1 and 1.5 after scarification. Scores are indicated as mean values for all animals.

BASF SE 1987 (16H0251/872141)

The test was carried out in equivalence to OECD guideline 404. One male and 2 female rabbits received the test item (CAS 71598 -17-9) unchanged on the clipped skin test site. The area of exposure was 2.5 cm x 2.5 cm. The test item was applied semiocclusively in a mixture consisting of 24 % active substance and 20 % acetic acid. The composition was applied in an amount of 0.5 mL over a period of 3 min and 1 hour. At the end of the exposure period the test substance was removed with Lutrol and water. The animals were observed for 30-60 min, 24 h, 48 h and 72 h. No erythema score could be calculated after 1h exposure time due to violet coloration caused by the material. The erythema score after 3 min exposure time was 0, also the edema score was 0 after 3 min and 1 h exposure time.

BASF SE 1987 (18H0251/872270)

The test was carried out in equivalence to OECD guideline 404. One male and 2 female rabbits received the test item (CAS 71598-17-9) unchanged on the clipped skin test site. The area of exposure was 2.5 cm x 2.5 cm. The test item was applied semiocclusively in a mixture consisting of 24 % active substance and 20 % acetic acid. The test item was applied in an amount of 0.5 mL over a period of 4 hours. At the end of the exposure period the test substance was removed with Lutrol and water. The animals were observed for 24 h, 48 h and 72 h. No erythema score could be calculated due to violet coloration caused by the material. The edema score was 0.

Eye irritation

Supporting

BASF SE 1978 (Report No. 77/126)

In a study equivalent to OECD guideline 405 the eye irritation with 5 male and 1 female rabbits was tested. The test item (CAS 71598-17-9) was applied in a mixture consisting of 24 % active substance and 20 % acetic acid. The animals were observed over a period of 8 days. Eye irritation was evaluated according to the criteria of Draize et al.

The mean scores at 24, 48 and 72 h for all animals were as following:

Cornea: 1.567

Iris: 0.22

Conjunctivae: 1.83

Chemosis: 2.72

The effects were not reversible.

Justification for classification or non-classification

The registered substance is a multi-constituent substance which contains acetic acid at ca. 33%. Acetic acid (CAS 64-19-7) is classified as corrosive to skin and eye according to Annex VI of Regulation (EC) No 1272/2008 (Skin Corr. 1A; H314). Taking into account the specific concentration limits for acetic acid, classification of the registered substance with Skin Corr. 1B; H314 is warranted under Regulation (EC) No 1272/2008 (SCL: 25% ≤ C < 90%). Furthermore, in two supporting in vivo eye irritation studies irreversible eye damage was observed supporting corrosive properties of the registered substance.