Registration Dossier

Administrative data

Description of key information

In view of the absence of genotoxic effects (in vitro and in vivo) and absence of carcinogenic effects in the oral and dermal repeated dose toxicity studies, no carcinogenicity is anticipated.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The information available is adequate for this dossier.

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

The genotoxicity of the substance has been assessed in vitro for three genotoxicity endpoints: genotoxicity in bacteria, cytogenicity in a chromosomal aberration test and a gene mutation assay in mammalian cells, which were all negative. Also two in vivo micronucleus test is available as part of the 90-day dermal toxicity study (NTP, 2016). No increases in micronuclei were seen in rats (both sexes) and in male mice. The effects seen in female mice at 1000 and 2000 mg/kg bw are difficult to judge. At 2000 mg/kg bw positive results were seen. This dose is however twice the limit dose for a micronucleus test in a repeated dose toxicity study and in the presence of haematological toxic effects and therefore not taken into account. At the 1000 mg/kg bw a minimal increase in micronuclei is seen, which cannot be assessed in absence of (historical) control values. For females it can be concluded that up to 500 mg/kg bw no increase in micronuclei is seen.

In addition, in the subchronic oral toxicity study (Triskelion, 2017) no carcinogenic effects or neoplasms were observed. Additionally, no neoplasms were observed in the supporting sub-chronic dermal (with oral exposure) NTP studies (NTP, 2016).

Justification for classification or non-classification

Based on the negative result of all genotoxicity tests OTNE does not need to be classified for genotoxicity according to the EU CLP (EC 1272/2008 and its amendments). In view of the absence of genotoxic effects (in vitro and in vivo) and absence of carcinogenic effects in the repeated dose toxicity studies, no carcinogenicity is anticipated.