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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1960
Report Date:
1960

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
BASF-Test. See details in remarks on material and methods.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): γ-Butyrolacton
- Physical state: colorless liquid
- Analytical purity: 99.5 %

Test animals

Species:
rat
Strain:
other: Schmitt-Fischer-Rats
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 129 - 218 g (mean), female: 141 - 188 g (mean)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2 and 10 %
Doses:
1600, 1250, 800 and 200 ml/kg bw = 1808, 1413, 904 and 226 mg/kg bw (coversion in mg/kg bw is based on the density of 1.13 g/cm3)
No. of animals per sex per dose:
1808, 1413, 904 mg/kg bw: 5
226 mg/kg bw: 3 females and 2 males
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 8 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 582 mg/kg bw
Remarks on result:
other: the conversion mg/kg bw is based on the density of 1.13 g/cm3
Mortality:
See details in remarks on results.
Clinical signs:
Staggering, abdominal and lateral position, narcosis.
Body weight:
no data.
Gross pathology:
1808 mg/kg bw: animals showed slight reddening of the small intestine and pale livers or patterns on the liver. One animal of the 1413 mg/kg bw showed myocarditis.

Any other information on results incl. tables

Mortality:

 Dose (mg/kg bw) Gender  1 h  24 h  48 h  7 days  14 days
 1808  male  0/5  4/5  4/5  4/5  4/5
 1808  female 0/5  5/5  5/5  5/5  5/5
 1413  male  0/5  3/5  3/5  3/5  4/5
 1413  female  0/5  0/5 0/5 0/5  0/5
 904  male  0/5  0/5  0/5  0/5  0/5
 904 female   0/5  0/5  0/5  0/5  0/5
 226  male  0/3  0/3  0/3  0/3  0/3
 226  female  0/2  0/2  0/2  0/2  0/2

The test substance caused toxicity (including mortality) in a dose dependent manner, after a single ingestion.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information According to Regulation (EC) 1272/2008 Criteria used for interpretation of results: EU