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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:
Nov - Dec 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically acceptable; study equivalent to OECD Guideline 401 with minor deviation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
only females tested
GLP compliance:
no
Remarks:
performed before GLP guidelines
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
grey, crystalline powder

Test animals

Species:
rat
Strain:
other: Hoechst AG Kastengrund - SPF breed
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG Kastengrund - SPF breed
- Weight at study initiation: 93 - 107g
- Fasting period before study: 16 hours before and 2 hours after application
- Housing: in plastic cages, softwood pellets
- Diet (e.g. ad libitum): Altromin 1324 (Altrogge GmbH, Lage/Lippe), 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:
- concentration in vehicle: 25 % (w/v)
Doses:
15000 mg/kg bw
No. of animals per sex per dose:
10 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations after application / Weighing once weekly
- Necropsy of survivors performed: yes
Statistics:
no

Results and discussion

Preliminary study:
An acute oral toxicity study with female rats was performed in 1964. The LD(50) dreived was 15000 mg/kg bw.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Remarks on result:
other: no effects
Mortality:
no deaths occured
Clinical signs:
no symptoms
Body weight:
normal body weight gain
Gross pathology:
no anomalies
Other findings:
no

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose of Hostanox SE 10 (LD50) was greater than 15000 mg per kg body weight. Based on the result of this study the test item is not subject for labelling and classification requirements according to regulatory requirements.
Executive summary:

Hostanox SE 10 was tested for its acute toxic properties in female rat via oral route. No animal died or showed clinical symptoms/macroscopic anomalies after application of 15000 mg/kg bw.

Therefore, the median lethal dose of Hostanox SE 10 (LD50) was greater than 15000 mg per kg body weight. Based on the result of this study the test item is not subject for labelling and classification requirements according to regulatory requirements.