Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
No data
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Old study, not fulfilling a guideline. No details on environmental conditions, test conditions, exposure concentrations and results.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
At the time of the study, no guideline was available. LD50 values were calculated using Thompson's method (1947) of moving averages and interpolation.
GLP compliance:
not specified
Test type:
other: no data

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Vinylidene chloride
- Source: Imperial Chemical Industries Limited, Mond Division, Runcorn, Cheshire
Before each experiment, stabilizer was removed by washing with alkali and water
- Purity: VDC was of analaR grade or of the next highest quality available

Test animals

Species:
mouse
Strain:
other: Alderley Park strain, specific pathogen-free
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: about 5 weeks old
- Weight at study initiation: 25 g
- Diet (e.g. ad libitum): standard pellet diet

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
No details
Doses:
5 concentrations
No. of animals per sex per dose:
5 groups of 6 mice (of each sex)
Details on study design:
No details
Statistics:
LD50 values were calculated respectively for male and female animals from Thompson's (1947) method of moving average and interpolation.

Results and discussion

Preliminary study:
Not applicable
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
217 mg/kg bw
95% CL:
>= 201 - <= 235
Sex:
female
Dose descriptor:
LD50
Effect level:
194 mg/kg bw
95% CL:
>= 171 - <= 221
Mortality:
No data
Clinical signs:
No data
Body weight:
No data
Gross pathology:
No data
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
other: Data not used for classification; data obtained from rat studies are considered to be more robust and useful for the identification of the acute toxic hazard
Remarks:
Criteria used for interpretation of results: not specified
Conclusions:
Oral LD50 males = 217 mg/kg bw
Oral LD50 females = 194 mg/kg bw
Executive summary:

In an acute oral toxicity study, groups of 5 weeks old Alderley Park mice (6/sex) were given a single oral dose of vinylidene chloride in corn oil at 5 doses. Oral LD50: Males = 217 mg/kg bw (201-235); Females = 194 mg/kg bw (171-221)