Registration Dossier

Administrative data

Description of key information

There is no carcinogenicity study available for m-chloroaniline (3-chloroaniline).
As described in section 1.2 (composition) the product contains ca. 99.5% 3-chloroaniline (CAS 108-42-9), ca. 0.2% 2-chloroaniline (CAS 95-51-2) and ca. 0.2% 4-chloroaniline (106-47-8).

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

For 3-chloroaniline and 2-chloroaniline no legal classification in regard to carcinogenity according to Annex VI to Regulation (EC) No 1272/2008 exists.

4-chloroaniline is legally classified as Carc. 1B according to Annex VI to Regulation (EC) No 1272/2008.

For mixtures the classification criteria of § 3.6.3 of Regulation (EC) No 1272/2008 applies.

The generic concentration limits of ingredients of a mixture classified as carcinogen that trigger classification of the mixture for Category 1B carcinogens is > 0.1%.

Justification for classification or non-classification

The mixture of 3-chloraniline containing 0.2% 2-chloroaniline and 0.2% 4-chloroaniline (Carc. 1B) has to be classified as Carc.1B.

Overall, a classification as Carc. 1B is justified based on the generic concentration limits of Regulation (EC) 1272/2008.