Alkenes, C15-18 α-, sulfurized

Endpoint summary

Description of key information

ACUTE TOXICITY: ORAL
- LD50 >2000 mg/kg bodyweight to female Wistar strain rats
ACUTE TOXICITY: DERMAL
- LD50 >2000 mg/kg bodyweight to male and female New Zealand White rabbits

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The key study was conducted under GLP conditions in accordance with the standardised guidelines OECD 423 and EU Method B.1 tris. It was assigned a reliability score of 1 in accordance with the criteria detailed by Klimisch (1997).

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

Quality of whole database:

The key study was conducted under GLP conditions in accordance with the principles of the standardised guidelines OECD 402 and EU Method B.3. It was assigned a reliability score of 1 in accordance with the criteria detailed by Klimisch (1997).

Additional information

Acute Toxicity: Oral

The acute oral toxicity of the test material was investigated in accordance with the standardised guidelines OECD 423, EU Method B.1 tris, EPA OPPTS 870.1100 and JMAFF 12 Nohsan, Notification No. 8147 under GLP conditions.

The undiluted test material was administered by gavage to two groups of three female Wistar rats at a limit dose level of 2000 mg/kg. The animals were observed for 15 days before being subjected to necropsy.

No mortality was seen throughout the study; hunched posture was noted in all animals on day 1 and piloerection was also noted on the first day in one animal. Bodyweight gains were considered to be normal. Rupture of the right and left medial lobe of the liver and watery-clear, dark red contents in the abdominal cavity were noted in one animal at macroscopic post mortem examination. Macroscopic post mortem examination of the other animals at termination did not reveal any abnormalities.

Under the conditions of this study, the oral LD50 of the test material was established to be >2000 mg/kg bodyweight and as such requires no classification in accordance with EU criteria.

 

Acute Toxicity: Inhalation

In accordance with the Column 2 adaptation of Annex VIII of Regulation (EC) No. 1907/2006 (REACH), it is considered justified to omit the acute toxicity by the inhalation route study (required under point 8.5.2) as testing by this route is inappropriate. Exposure via the inhalation route is not relevant due to the substance being a liquid with a low vapour pressure; therefore the acute oral and acute dermal studies are deemed more appropriate to address acute toxicity exposure.

 

Acute Toxicity: Dermal

The potential of the test material to cause acute toxic effects when administered by the dermal route was investigated in a test using a method equivalent to those set out in the OECD 402 and EU Method B.3 guidelines. The test was conducted under GLP conditions.

The test material was administered once dermally to 5 male and 5 female New Zealand White rabbits at a limit dose of 2000 mg/kg bw. The test material applied undiluted and the animals were exposed for 24 hours.

There was no mortality and no systemic effects related to administration of the test material. Erythema and/or oedema of the skin were observed at the application site on days 1 through to 5. All animals appeared normal at necropsy. Mean body weights of the animals increased over the duration of the study.

Under the conditions of this study the LD50 was found to be >2000 mg/kg bw in male and female rabbits and therefore requires no classification in accordance with EU criteria.

Justification for selection of acute toxicity – oral endpoint
Only one study available.

Justification for selection of acute toxicity – inhalation endpoint
A data waiver has been submitted to address this endpoint.

Justification for selection of acute toxicity – dermal endpoint
Only one study available.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the test material does not require classification for acute toxicity.