Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Unpublished RIFM report. No details were done on the experimental study.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Special issue IV: Monographs on Fragrance Raw Materials
Author:
Opdyke
Year:
1978
Bibliographic source:
Food Cosmet. Toxicol. 16, 715-716.
Reference Type:
study report
Title:
Unnamed
Year:
1973

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
no data
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Givaudan index 1961.

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS:
- Species: rat
- Strain: no data

- Sex: no data
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: no data
- Food consumption: no data
- Water consumption: no data
- Acclimation period: no data

Environmental conditions: no data

In-life dates: no data

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
no data
Doses:
2560; 3200; 4000; 5000 mg/kg
No. of animals per sex per dose:
10 (sex unspecified)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: no data
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- examinations performed: other: no data
Statistics:
no data on statistical method used for calculation of LD50

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
3 600 mg/kg bw
95% CL:
3 130 - 4 070
Mortality:
2560 mg/kg lethal, 3 deaths. 
3200 mg/kg lethal, 4 deaths. 
4000 mg/kg lethal, 6 deaths. 
5000 mg/kg lethal, 10  deaths. 
Clinical signs:
Toxic signs were lethargy and loss of righting reflex.
Body weight:
no data
Gross pathology:
no data

Any other information on results incl. tables

2560 mg/kg lethal, 3 deaths, Lethargy. 

3200 mg/kg lethal, 4 deaths,  Lethargy. 

4000 mg/kg lethal, 6 deaths, Lethargy. 

5000 mg/kg lethal, 10  deaths. Toxic signs were lethargy and loss of righting reflex.


3600 mg/kg calculated LD50, 95% limits=3130-4070 mg/kg.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to EU directive 67/548/EEC, the substance is considered not classified for acute oral toxicity.