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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:
1964
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
Pre-guideline and pre-GLP study. Only basic data given but considered sufficient for a weight of evidence (purity not reported, test system details not reported; body weight and gross pathology not reported).

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1964

Materials and methods

Principles of method if other than guideline:
Rats were given a single oral dose of test item and then observed for 14 days.
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

Test animals

Species:
rat
Strain:
Osborne-Mendel
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: rats: 180-350 g
- Fasting period before study: 18 hours
- Diet, ad libitum
- Water, ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Not reported
Doses:
No data
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: The rats were observed until the survivors had returned to normal in appearance and weight
Statistics:
LD50s were computed by the method of Litchfield and Wilcoxon (1949).

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 670 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 265 - <= 2 200
Mortality:
Animals died within 4 hours to 2 days after treatment.
Clinical signs:
Rough fur, depression
Body weight:
No data
Gross pathology:
No data

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, rats (5/sex/dose) were administered the test substance by gavage with a stomach tube. Animals were then observed for mortality and clinical signs for 14 days.

Deaths occurred between 4 hours and 2 days and clinical signs were reported to be rough fur and depression.

Combined oral LD50 = 1670 mg/kg bw (95% CL 1265 -2200 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.

This study is considered as sufficiently reliable in a weight of evidence approach for the purpose of acute oral toxicity endpoint.