Reaction mass of [(3,7-dimethyloct-6-en-1-yl)oxy]acetaldehyde and [(3,7-dimethyloctyl)oxy]acetaldehyde

Endpoint summary

Description of key information

Acute oral toxicity: similar to OECD TG 401: LD50 >5000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Study period not specified

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Pre-OECD, Pre-GLP study without detailed documentation.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

pre-GLP study

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No details

Route of administration:

oral: unspecified

Vehicle:

not specified

Details on oral exposure:

No details

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 animals per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: at least daily
- Necropsy of survivors performed: not mentioned in the report

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

2/10 animals died. Death was observed on day 5 and 12.

Clinical signs:

Lethargy was observed.

Interpretation of results:

other: not classified: criteria not met

Remarks:

according to EU CLP Regulation (EC) No. 1272/2008 and its amendments.

Conclusions:

The acute oral toxicity test showed an LD50 of >5000 mg/kg bw.

Executive summary:

In an acute oral toxicity study performed similar to OECD 401 (pre-OECD, pre-GLP) 10 rats were administered the test substance orally at a dose level of 5000 mg/kg bw. During the 14 -day observation period 2/10 rats died. Mortality was observed at day 5 and 12. The clinical sign observed was lethargy. The acute oral LD50 for the test substance in rats was determined to be >5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The acute oral toxicity result is of sufficient quality and adequate for this dossier.

Additional information

Acute oral toxicity:

In an acute oral toxicity study performed similar to OECD 401 (pre-OECD, pre-GLP) 10 rats were administered the test substance orally at a dose level of 5000 mg/kg bw. During the 14 -day observation period 2/10 rats died. Mortality was observed at day 5 and 12. The clinical sign observed was lethargy. The acute oral LD50 for the test substance in rats was determined to be >5000 mg/kg bw.

Additional information:

In the acute oral toxicity study of Moreno, 1973 also a dermal toxicity study is included. The acute dermal toxicity study was conducted with 10 rabbits receiving a dermal application of 5000 mg/kg bw of the test material. The animals were observed for mortality and/or clinical signs for 14 days. No symptoms were observed and 0/10 animals died. The dermal LD50 exceeded 5000 mg/kg bw and this result does not have an impact on the classification.

Justification for classification or non-classification

The substance does not have to be classified for acute and dermal oral toxicity in accordance with EU CLP Regulation (EC) No. 1272/2008 and its amendments.