Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test substance was administered to male and female rats by gavage in single doses of 2.4, 2.9, 3.2 or 4.2 mL per kg bw. After treatment the rats received stock diet and tap water ad libitum. They were observed for signs of intoxication during a 14 day period, after wich autopsies were carried out on survivors and the LD 50 was calculated.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
- Name of test material (as cited in study report): Bourgeonal
- Physical state: Colourless liquid
- Lot/batch No.: V-02759

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Central Institute for the Breeding of Laboratory Animals TNO, Zeist, Netherlands.
- Age at study initiation: Young adult, age not specified.
- Weight at study initiation: Males 200 to 260 g, females from 100 to 134 g.
- Fasting period before study: Overnight
- Diet (e.g. ad libitum): Stock diet available ad libitum
- Water (e.g. ad libitum): Ad libitum
- Housing: In groups of 5 in stainless-steel cages with grid-bottom and front.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 1 °C
- Air changes (per hr): Well ventilated, but air changes not specified.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2.4, 2.9, 3.5 or 4.2 mL/kg bw
No. of animals per sex per dose:
Five/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: Observed for signs of intoxication.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2.66 mL/kg bw
Based on:
test mat.
95% CL:
2.43 - 2.91
Mortality:
Deaths occurred between 7 h and 3 days after dosing. Then the survivors recovered gradually and looked quite healthy at the end of the observation period.
Clinical signs:
Within a few hours after treatment the rats showed sedation and signs of ataxia. Later, signs of emaciation, encrustations around eyes and nostrils and coma were frequently observed.
Gross pathology:
Macroscopic examination of the survivors did not reveal any treatment-related gross alterations.

Any other information on results incl. tables

Doses applied and mortality figures:

Dose (mL/kg)

Mortality

Number

Percent

Males

Females

2.4

2/5

1/5

30

2.9

3/5

4/5

70

3.5

4/5

5/5

90

4.2

5/5

5/5

100

Applicant's summary and conclusion

Conclusions:
The test substance was assessed for acute oral toxicity in rats using a single dose administered by oral gavage. The LD50 was calculated to be 2.66 mL/kg bw with 95% confidence limits of 2.43 and 2.9 mL/kg bw.