Registration Dossier

Administrative data

Description of key information

LD50(oral) > 2000 mg/kg
LD50(dermal) > 2000 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

The acute oral toxicity of the test substance was evaluated in a study according to OECD Test Guideline 420 under GLP. A limit test with the test substance dose of 2000 mg/kg bodyweight was performed. The substance was applied with the vehicle sesame oil by oral gavage to five Wistar rats of both sexes, which were observed for 14 days post application. No mortality occured. Body weights gain was not impaired, while no pathological abnormalities were found. Clinical signs like diarrhoea, pilorection or decreased motor acitivity were observed maximally until day 2. Based on these results, the rat oral acute toxicity LD50 of the test substance was > 2000mg/kg bodyweight. Therefore, the test substance is considered practically non-toxic.

The acute dermal toxicity of a close homologue (CAS-No. 50849-47-3) of the registered substance, which has a C9 instead of a branched C9 side chain and lacks a methyl group at the oxime carbon atom, has been tested in a study according to a FDA guideline.

A limit test with the test substance dose of 2000 mg/kg bodyweight was performed. The test substance was applied unchanged under occlusive conditions for 24h to the skin of ten New Zealand White rabbits of both sexes, which were observed for 14 days post application. One rabbit was found dead on day 4. Body weights stagnated or increased, while no pathological abnormalities were present in all rabbits, except the dead rabbit. Thus, the rabbit acute dermal toxicity LD50 of the test substance was > 2000mg/kg bodyweight and is therefore considered practically non-toxic.

The acute dermal toxicity of a close homologue (CAS # 1233873 -37 -4), which has a branched C12 instead of a branched C9 side chain and lacks a methyl group at the oxime carbon atom, was assessed in a study according to the FDA, cf. 16 CFR 1500.40 guideline. 3 male and 3 female white rabbits were dosed with 8410 mg/kg bw using an occlusive patch for 24 hours. All animals survived until the end of the observation period (14 days). At the higher dose levels of 10000, 12600, 15870 and 200000 mg/kg, an inconstistent death pattern was observed with the 3 males and 3 females tested at each dose level. Based on the available data, the LD50 of the test substance was greater than 8410 mg/kg bodyweight but less than 10000 mg/kg bodyweight. The test substance is thus considered practically non-toxic.

Based on a read-across of these results, the registered substance is also considered to be practically nontoxic by dermal route.

Since inhalation is no primary route of exposure the registered substance was not tested for this endpoint.

Justification for classification or non-classification

By applying the GHS classification system for chemical substances according to Regulation (EC) 1272/2008 the registered substance has not to be labelled for its acute toxicity.