Reaction mass of tetrasodium (E)-7-((4-(4-chloro-6-(3-(2-(sulfooxy)ethylsulfonyl)phenylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenyl)diazenyl)naphthalene-1,3,6-trisulfonate and (E)-7-((4-(4-chloro-6-(3-(2-(sulfooxy)ethylsulfonyl)phenylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenyl)diazenyl)naphthalene-1,3,6-trisulfonic acid

Endpoint summary

Description of key information

Non sensitising

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

There are no experimental available data of the target substance, thus the information on the Similar Substance 01 has been taken into account. The structural differences occurring between the target substance and Similar Substance 01 are not expected to significantly impact the skin sensitisation potential, thus the read across approach can be considered as representative and appropriate (details in the document attached to the IUCLID section 13).

To assess the allergenic potential the test substance has been tested in albino guinea pigs, according to the OECD guideline 406.

Positive reaction was found on 3 animals of the total 20 (15 % corresponding to an intradermal induction dose of 5 %).

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

SKIN SENSITIZATION

Category 1

According CLP Regulation N. 1272/2008, a substances shall be classified as skin sensitisers (Category 1) where data are not sufficient for sub- categorisation (1A and 1B) in accordance with the following criteria:

(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or

(b) if there are positive results from an appropriate animal test ( according to 3.4.2.2.4.1).

At this point, when an adjuvant type guinea pig test method for skin sensitisation is used, a response of at least 30 % of the animals is considered as positive. For a non-adjuvant guinea pig test method a response of at least 15 % of the animals is considered positive.

Sub-category 1A

Substances showing a high frequency of occurrence in humans and/or a high potency in animals can be presumed to have the potential to produce significant sensitisation in humans. Severity of reaction may also be considered.

Specific criteria:

Local lymph node assay-EC3 value ≤ 2 %

Guinea pig maximisation test-≥ 30 % responding at ≤ 0,1 % intradermal induction dose or ≥ 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose

Buehler assay - ≥ 15 % responding at ≤ 0,2 % topical induction dose or ≥ 60 % responding at > 0,2 % to ≤ 20 % topical induction dose

Sub-category 1B

Substances showing a low to moderate frequency of occurrence in humans and/or a low to moderate potency in animals can be presumed to have the potential to produce sensitisation in humans. Severity of reaction may also be considered.

Local lymph node assay - EC3 value > 2 %

Guinea pig maximisation test- ≥ 30 % to < 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose or ≥ 30 % responding at > 1 % intradermal induction dose

Buehler assay - ≥ 15 % to < 60 % responding at > 0,2 % to ≤ 20 % topical induction dose or ≥ 15 % responding at > 20 % topical induction dose.

The substance has not to be classified as skin sensitiser because it does not meet the classification criteria according to the CLP Regulation (EC n. 1272/2008).