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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
Study period:
1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: basic data given, comparable to guidelines
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
unclear if limit test (only highest administrable dose stated)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of Fatty acids, montan-wax and Montan wax
EC Number:
914-468-7
Molecular formula:
R-CH2-COOH mainly
IUPAC Name:
Reaction mass of Fatty acids, montan-wax and Montan wax
Details on test material:
- Name of test material (as cited in study report): Hoechst-Wachs S
- Substance type: yellow flakes
- Physical state: solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: SPF breeding colony
- Strain: Wistar K
- Weight at study initiation: mean 99 g
- Fasting period before study: 16 h
- Diet (e.g. ad libitum): Standard-ALTROMIN R (Altromin GmbH, Lage/Lippe, Germany), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25% suspension
Doses:
15000 mg/kg bw (highest administrable dose), lower doses not stated
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Remarks on result:
other: no animal died within the observation period

Any other information on results incl. tables

- no animal died during the test

- all animals showed normal behaviour after application

- body weight development was not impaired

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information CLP-Regulation
Conclusions:
Single application of 15000 mg test substance (Hoechst-Wachs S) per kg bw did not cause lethality in female Wistar-rats within the 14 day observation period, resulting in a LD50 > 15000 mg/kg bw.
Executive summary:

Ten female Wistar-rats were subjected to test acute oral toxicity. The test substance (Hoechst-Wachs S) was administered by gavage at the highest applicable dose of 15000 mg/kg bw. No animal died under these conditions, resulting in a LD50 > 15000 mg/kg bw.