Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Non mutagenic

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There are no experimental available data of the target substance, thus the information on the Similar Substance 03 has been taken into account. The structural differences occurring between the target substance and Similar Substance 03 are not expected to significantly impact the mutagenic potential, thus the read across approach can be considered as representavive and appropriate (details in the document attached to the IUCLID section 13).

Two different test are available which give information about the mutagenic potential of the Similar Substance 01.

In the key study the test substance was tested for mutagenicity with the strains TA 100, TA 1535, TA 1537 and TA 98 of Salmonella typhimurium, according to the OECD guideline 471.

The mutagenicity studies were conducted in the standard plate test (Ames Test) and in a modified preincubation test (Prival Test). The studies were performed in the absence and in the presence of a metabolizing system derived from rat or hamster liver homogenate. A dose range of 6 different doses from 20 microgram/ plate to 10000 microgram/plate was used.

Control plates without mutagen showed that the number of spontaneous revertant colonies was similar to that described in the literature. All the positive control compounds gave the expected increase in the number of revertant colonies.

Toxicity: The test compound proved to be not toxic to the bacterial strains. 10000 microgram/plate was chosen as top dose level for the mutagenicity study.

a) Ames Test:

Mutagenicity: In the absence of the metabolic activation system the test compound did not show a dose dependent increase in the number of revertants in any of the bacterial strains. Also in the presence of a metabolic activation system, treatment of the cells with the test substancedid not result in relevant increases in the number of revertant colonies.

b) Prival Test:

In the presence of hamster liver S-9 using the preincubation method according to Prival the test substance did not induce a significant increase in the number of revertant colonies, with any of the tester strains.

In the supporting study, the test substance was examined in the mutagenicity screening test in bacteria, according to the OECD guideline 471. Under these test conditions the test substance in concentrations of 4 µg to 10,000 µg showed no mutagenic activity.

Justification for classification or non-classification

GERM CELL MUTAGENICITY

This hazard class is primarily concerned with substances that may cause mutations in the germ cells of humans that can be transmitted to the progeny. However, the results from mutagenicity or genotoxicity tests in vitro and in mammalian somatic and germ cells in vivo are also considered in classifying substances and mixtures within this hazard class.

Category 1: Substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans. Substances known to induce heritable mutations in the germ cells of humans.

Categoty 2: Substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans.

Classification for heritable effects in human germ cells is made on the basis of well conducted, sufficiently validated tests as In vitro mutagenicity tests such as these indicated in 3.5.2.3.8:

- in vitro mammalian chromosome aberration test;

- in vitro mammalian cell gene mutation test;

- bacterial reverse mutation tests

The substance does not meet the classification criteria according to the 3.5. of the CLP Regulation (EC n.1272/2008)