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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
08 Apr - 14 Apr 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given in summarized study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
; observation period post-treatment: 6 days; only female animals used
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): Oleate de Decyle S
- Analytical purity: no data given
- Code: 10117
- Lot/batch No.: 0609 G

Test animals

Species:
mouse
Strain:
other: NMRI EOPS
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 19-21 g

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 female animals
Control animals:
no
Details on study design:
Assessment of the acute oral toxicity of the test material after administration of a single dose.
Observation of the animals for 6 days post treatment.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: mouse
Mortality:
All animals survived.
Clinical signs:
No abnormalities were observed.
Body weight:
Weight growth was satisfactory.

Any other information on results incl. tables

Under the experimental conditions of the test chosen, the LD50 was >2000 mg/kg bw in female mice. No mortality occurred.

Therefore the test material does not fulfill the requirements to be classified according to GHS- (1272/2008 EC) or EU-(67/548 EEC) criteria.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU