Reaction mass of Fatty acids, montan-wax and Montan wax

Acute Toxicity: oral

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

Test material information

Constituent 1

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.