3-methylcyclopentadecan-1-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Basic data given: comparable to standard guideline OECD 401. No details on test item purity, form or batch number, on test animals, environmental conditions of animal room and body weight.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

No details on test animals, environmental conditions of animal room and body weight.

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-methylcyclopentadecan-1-one

EC Number:

208-795-8

EC Name:

3-methylcyclopentadecan-1-one

Cas Number:

541-91-3

Molecular formula:

C16H30O

IUPAC Name:

3-methylcyclopentadecan-1-one

Test material form:

not specified

Details on test material:

- Physical state:no data

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 animals/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for toxicity and clinical signs daily for 14 days.
- Necropsy of survivors performed: Yes

Statistics:

No data

Results and discussion

Preliminary study:

Not applicable

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the oral LD50 for the test substance is higher than 5000 mg/kg bw in rats therefore it is not classified according to the Annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.

Executive summary:

In an acute oral toxicity study (limit test), performed similarly to OECD Guideline No. 401, groups of rats (10/dose) were administered a single oral dose of test material at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs daily for 14 days.

 

No mortality or clinical signs were observed at 5000 mg/kg bw. No abnormalities were noted at necropsy. 

Rat Oral LD50 = 5000 mg/kg bw

 

Under the test conditions, test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS. 

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.