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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
no data on analytical purity of test substance given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no data on analytical purity of test substance given
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Geranyl formate
EC Number:
203-339-4
EC Name:
Geranyl formate
Cas Number:
105-86-2
Molecular formula:
C11H18O2
IUPAC Name:
3,7-dimethylocta-2,6-dien-1-yl formate

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Weight at study initiation: 150 - 200 g
- Fasting period before study: overnight
- Housing: individually
- Diet: commercial diet
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50% (v/v)

Doses:
range-finding study: up to 10 mL/kg bw (corresponding to 9220 mg/kg bw based on a relative density of 0.922 g/cm³), not further specified
main study: 6 mL/kg bw (corresponding to 5532 mg/kg bw based on a relative density of 0.922 g/cm³)
No. of animals per sex per dose:
range-finding study: 5 to 6 animals in total, not further specified
main study: 5 per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: range-finding study: 2 days; main study: 14 days
- Frequency of observations and weighing: range-finding study: Toxic signs and mortality were recorded at 1, 4, 24 and 48 hours.; main study: Toxic signs and mortality were recorded at 1 and 4 hours and then once daily for a period of 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: toxic signs, gross pathology

Results and discussion

Preliminary study:
No death occurred in rats which received test substance at any dose level up to 10 mL/kg bw.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6 mL/kg bw
Based on:
test mat.
Remarks on result:
other: (corresponding to 5532 mg/kg bw based on a relative density of 0.922 g/cm³)
Mortality:
One death occurred in a group of five rats receiving 6 mL/kg bw.
Clinical signs:
Toxic signs of piloerection and ataxia were noted for one rat at 6 mL/kg bw.
Gross pathology:
No abnomalities were noted in animals that died following treatment or were killed at termination of the study.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
In this acute oral toxicity study in rats a LD50 value of > 6 mL/kg bw (corresponding to > 5532 mg/kg bw based on a relative density of 0.922 g/cm³) was found.
Executive summary:

The acute oral toxicity of the test substance was assessed in a study similar to OECD Guideline 401 (1971).Based on a preliminary study, groups of 5 male and 5 female rats were given a dose of 6 mL/kg bw via gavage. One animal died at 6 mL/kg bw. Thus, a LD50 > 6 mL/kg bw (corresponding to > 5532 mg/kg bw based on a relative density of 0.922 g/cm³) was determined.

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