Geranyl formate

Acute Toxicity: oral

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

Test material information

Constituent 1

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:

other: 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.