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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:
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

Constituent 1
Reference substance name:
Montan waxes, Type E
IUPAC Name:
Montan waxes, Type E
Constituent 2
Reference substance name:
Reaction mass of Fatty acids, montan-wax and Fatty acids, montan-wax, ethylene esters and Montan wax
EC Number:
914-475-5
Molecular formula:
R-CH2-COOR1OOC-CH2-R mainly
IUPAC Name:
Reaction mass of Fatty acids, montan-wax and Fatty acids, montan-wax, ethylene esters and Montan wax
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:
- no signs of toxicity observed
Body weight:
- body weight development was not impaired
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.