2-Oxetanone, 3-C12-16-alkyl-4-C13-17-alkylidene derivs., (4E)-

Endpoint summary

Description of key information

Acute oral (OECDTG420): LD50 >2000 mg/kg bw

Acute dermal (OECDTG402): LD50 >2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Quality of whole database:

The study has klimisch code 1.

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

Value:

> 2 000 mg/kg bw

Quality of whole database:

The study has klimisch code 1.

Additional information

Executive summaries of the studies performed with the source substance:

 

This study was performed to assess the acute oral toxicity of P-2290 to the rat. The method followed was that described in: EEC Methods for the determination of toxicity, Annex to Directive 92/69EEC (OJ No. L383A, 29.12.92), Part B, Method B. 1 bis. Acute toxicity (oral) - fixed dose method. OECD Guideline for Testing of Chemicals No.420 'Acute Oral Toxicity - Fixed Dose Method' Adopted 17 July 1992. A group of ten fasted rats (five males and five females) was given a single dose by oral gavage of the test substance, as supplied by the Sponsor, at a dose level of 2000 mg/kg bodyweight. This dose level was chosen after review of results from a sighting study. All animals were killed and examined macroscopically on Day 15, the end of the observation period. There were no deaths. Clinical signs of reaction to treatment were confined to piloerection, hunched posture and waddlingiunsteady gait, seen in all rat. In addition, abnormal faeces and ungroomed appearance were less commonly observed. Recovery of rats was complete in all instances by Day 2. All rats were considered to have achieved satisfactory bodyweight gains throughout the study. Macroscopic examination of animals killed at study termination on Day 15 revealed no abnormalities. The LD50 is > 2000 mg/kg bw.

 

A study was performed to assess the acute dermal toxicity of P-2290 to the rat. The method followed was that described in: EEC Methods for the determination of toxicity, Annex to Directive 92/69/EEC (OJ No. L383A7 29.12.92), Part B, Method B.3. Acute toxicity (dermal). OECD Guideline for Testing of Chemicals No. 402 "Acute Dermal Toxicity". Adopted: 24 February 1987.

A group of ten rats (five males and five females) received a single topical application of the test substance, administered as supplied at a dose level of 2000 mg/kg bodyweight. All animals were killed and examined macroscopically on Day 15, the end of the observation period. There was no systemic response in any animal throughout the study. Slight to well-defined dermal irritation was noted in three animals, resolving in all instances by Day 7.

No dermal response to treatment was recorded for any other animal throughout the study.A slightly low bodyweight gain was recorded for one female on Day 8, with a similar trend noted for one further female on Day 15. All other animals were considered to have achieved satisfactory bodyweight gains throughout the study. No abnormalities were recorded at the macroscopic examination on Day 15. The acute lethal dermal dose to rats of P-2290 was demonstrated to be greater than 2000 mg/kg bodyweight.

 

Justification for classification or non-classification

Based on the available information, the substance does not have to be classified and has no obligatory labelling requirement for acute oral, acute inhalation and acute dermal toxicity according to Regulation (EC) No 1272/2008 and its amendments.