Reaction mass of fatty acids, montan-wax, 1-methyl-1,3- propanediyl esters and fatty acids, montan-wax, ethylene esters and fatty

Acute Toxicity: oral

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:

From 19 FEB 1997 to 5 MAR 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD TG 401), for justification of read-across see Chapter 1 of CSR

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

, minor deviations (the acclimatization period of testing animals was at least one day, but breeding was at identical conditions)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Montan waxes, Type E

IUPAC Name:

Montan waxes, Type E

Details on test material:

- Name of test material (as cited in study report): Hoechst-Wachs E
- Substance type: light yellow substance
- Storage condition of test material: darkness at room temperature in a fume cupboard

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund; SPF breeding colony
- Age at study initiation: males: approx. 7 weeks, females: approx. 8 weeks
- Weight at study initiation: males mean: 168 g, females mean: 167 g
- Fasting period before study: 16 h
- Housing: in macrolon cages (type 4) in groups of 5
- Diet (e.g. ad libitum): ssniff(R) R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least one day (breeding at identical conditions)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3 °C
- Humidity (%): 50+-20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20% suspension

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

Doses:

limit dose: 2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: weekly
- Frequency of observations: twice every day/ weekends and holidays only once
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no animals died within the 14-day observation period

Mortality:

- no deaths occured

Clinical signs:

other: - no signs of toxicity observed

Gross pathology:

- animals killed at the end of the observation period showed no macroscopically visible changes

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Single application of the limit dose of 2000 mg test substance (Hoechst-Wachs E) per kg bw did not cause lethality in male and female Wistar rats during the 14 day observation period, resulting in a LD50 > 2000 mg/kg bw.

Executive summary:

Male and female Wistar rats (5 per sex) were subjected to test acute oral toxicity. The test substance (Hoechst-Wachs E) was administered by gavage at the limit dose of 2000 mg/kg bw. No animal died during the 14 day observation period, resulting in a LD50 > 2000 mg/kg bw.

Therefore, the test substance has not to be classified for acute oral toxicity according to Regulation (EC) 1272/2008 and Council Directive 67/548/EEC.