Rosetal A

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Justification for type of information:

Information is used for read across to Rosetal A (target)

Data source

Reference

Reference Type:

publication

Title:

Food Flavourings and Compounds of Related Structure I. Acute Oral Toxicity

Author:

P.M. Jenner, et al.

Year:

1964

Bibliographic source:

Fd Cosmet. Toxicol. Vol. 2, pp. 327-343. Pergamon Press 1964. Printed in Great Britain

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

No specific guideline was mentioned in the publication.

GLP compliance:

no

Remarks:

The study was performed in 1964.

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of (2E)-3,7-dimethylocta-2,6-dien-1-ol and (2Z)-3,7-dimethylocta-2,6-dien-1-ol

EC Number:

906-125-5

Molecular formula:

Unspecified

IUPAC Name:

Reaction mass of (2E)-3,7-dimethylocta-2,6-dien-1-ol and (2Z)-3,7-dimethylocta-2,6-dien-1-ol

Test material form:

liquid

Test animals

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Fasting period before study: 18 hours
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

No data

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

All doses were given by intubation.
All animals were maintained under close observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal and showed weight gain.
The usual observation period was 2 weeks; in a few cases, where no acute toxic signs were seen, the animals were observed for only one week.

Statistics:

Litchfield & Wilcoxon (1949)

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 600 mg/kg bw

Based on:

test mat.

95% CL:

2 840 - 4 570

Mortality:

Time of death between 4-18 hours.

Clinical signs:

coma

other:

Applicant's summary and conclusion

Interpretation of results:

other: Not harmful in accordance with EU CLP (EC no 1272/2008 and its amendments)

Conclusions:

The substance has an LD50 of > 2000 mg/kg bw in a test similar to OECD TG 401.

Executive summary:

Substance is tested in an acute oral toxicity study similar to OECD TG 401. In 1964 Jenner et al. performed an acute oral toxicity study in which groups of 10 young adult Osborne-Mendel rats evenly divided by sex were dosed by gavage. All animals were maintained under close observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal and showed weight gain. The usual observation period was 2 weeks. The LD50 is derived based on the method of Litchfield & Wilcoxon (1949). The LD50 result in 3600 mg/kg bw (2840-4570 95% confidence limits).