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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
28 May to 31 October 1980
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
Pre-guideline and pre-GLP study. Only basic data given for this range-finding study and only two animals used per dose (one male and one female), but considered sufficiently reliable in a weight of evidence for the purpose of hazard assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no. of animals were lesser than 5 per dose (1/sex/dose); no details on environmental conditions, only 7 days observation period followed
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Physical state: Lemon clear liquid

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: not reported
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 17-21 g
- Fasting period before study: for four hours
- Housing: individual cages
- Diet (e.g. ad libitum): not reported
- Water (e.g. ad libitum): not reported
- Acclimation period: not reported

ENVIRONMENTAL CONDITIONS: not reported

IN-LIFE DATES: not reported

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Groundnut oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10% v/v in Groundnut oil

DOSE VOLUME APPLIED: 0.1, 0.2, 0.5, 1.0 and 2.0 mL/kg bw
Doses:
0.1, 0.2, 0.5, 1.0 and 2.0 mL/kg bw
No. of animals per sex per dose:
1/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: Yes; all survivors were killed by CO2 asphyxiation and examined post mortem after 7 days. All animals dying were autopsied.
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
0.5 mL/kg bw
Based on:
test mat.
Remarks on result:
other: Corresponding to 450 mg/kg bw
Mortality:
- Mortality was observed in 1/2, 2/2 and 2/2 animals at 0.5, 1 and 2 mL/kg bw, respectively.
- No mortality was observed at 0.1 and 0.2 mL/kg bw.
Clinical signs:
Most mice were showing signs of stress within 30 minutes-1 hour after treatment. The mice dosed at 1 and 2 mL/kg bw, and one animal dosed at 0.5 mL/kg bw, became semicomatose/comatose, hypothermic and showed laboured breathing within 1 hour. All these animals died within 2-24 hours.
The surviving animal dosed at 0.1 and 0.2 mL/kg bw recovered within 18 hours.
Body weight:
Apart from the male mouse dosed at 0.5 mL/kg bw, all surviving animals gained weight during the 7 day observation period.
Gross pathology:
Autopsy of the mice that died revealed:
- Irritation of the stomach and small intestines, dark spleen, congested lungs and mottled liver.
- Histological examination did not reveal liver necrosis.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Under the test conditions, test material is classified Category 4 (H302: Harmful if swallowed) according to the Regulation (EC) No. 1272/2008 and of the GHS as the LD50 value is comprised between 300 and 2000 mg/kg bw.
Executive summary:

In an acute oral toxicity study, mice (1/sex/dose) were given a single oral (gavage) dose of test item at 0.1, 0.2, 0.5, 1.0 and 2.0 mL/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 7 days and were all sacrificed for macroscopic examination.

Mortality was observed in 1/2, 2/2 and 2/2 animals at 0.5, 1 and 2 mL/kg bw, respectively. No mortality was observed at 0.1 and 0.2 mL/kg bw. Most mice were showing signs of stress within 30 minutes-1 hour after treatment. The mice dosed at 1 and 2 mL/kg bw, and one animal dosed at 0.5 mL/kg bw, became semi-comatose/comatose, hypothermic and showed laboured breathing within 1 hour. All these animals died within 2-24 hours. The surviving animal dosed at 0.1 and 0.2 mL/kg bw recovered within 18 hours. Apart from the male mouse dosed at 0.5 mL/kg bw, all surviving animals gained weight during the 7 day observation period.

Autopsy of the mice that died revealed: Irritation of the stomach and small intestines, dark spleen, congested lungs and mottled liver. Histological examination did not reveal liver necrosis.

Mice oral LD50 = 0.5 mL/kg bw (corresponding to 541.5 mg/kg bw).

Under the test conditions, test material is classified Category 4 (H302: Harmful if swallowed) according to the Regulation (EC) No. 1272/2008 and of the GHS as the LD50 value is comprised between 300 and 2000 mg/kg bw..