Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given:comparable to guidelines/standards.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dilutine Moins Cinq (DM5)
- Composition of test material, percentage of components: Partially dearomatized white spirit, produced from low aromatic white spirit (LAWS) by hydrogenation; 3.5% aromatics
- Relative density 60/60°F = 0.765

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Ltd., Manston, Kent, UK
- Age at study initiation: 12 weeks
- Housing: 4 animals of one sex in each cage
- Fasting period before study:yes, overnight before dosing
- Diet (e.g. ad libitum): ad libitum, except during the fastinf period
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
No data
Doses:
1, 2, 4 and 8 mL/kg bw
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 9 days
Statistics:
None

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality in all groups.
Clinical signs:
No data
Body weight:
No data
Gross pathology:
No data
Other findings:
No data

Any other information on results incl. tables

No data

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The oral LD50 for rats is > 8 mL/kg bw (~ 6000 mg/ kg bw).
Executive summary:

This study examined the acute toxicity of Dilutine M5 to rats via oral exposure. After an overnight fasting period, 2 female and 2 male rats were exposed to 1, 2, 4 or 8 mL/kg bw of undiluted test material by oral gavage, followed by a 9-day observation period. No rats died during the experiment. The oral LD50 for rats is > 8 mL/kg bw (~ 6000 mg/kg bw).