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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
analytical purity and storage condition are not reported
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 5601-57-2
- Physical state: clear liquid
- Analytical purity: responsibility of the Sponsor
- Lot/batch No.: J-253
- Stability under test conditions: no apparent change in the physical state of the test article during administration
- Storage condition of test material: no data
- Other: specific gravity=1.203ml/ml

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Labs., Wilmington, Mass.
- Age at study initiation: no info
- Weight at study initiation: 180-280g (fasted)
- Fasting period before study: yes, 18h
- Housing:individually or in groups, according to sex, in stainless steel 1/2'' wire mesh cages. Size i n accordance with the "Guide f o r the Care and Use of Laboratory Animals" of the Institute of Laboratory Resources, National Research .Council
- Diet (e.g. ad libitum): Wayne Lab Blox, ad l ibi tum
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C±3°C
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12h dark/12h light


IN-LIFE DATES: From: 1985-07-29 To: 1985-08-12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg
No. of animals per sex per dose:
10 (5 males and 5 females)
Control animals:
no
Remarks:
not required according to OECD 401
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: pharmacological and toxicological effects: at 1 and 4 hours and once a day for 14 days; viability: twice a day; body weight: d0 and d14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: unbounded LD50
Mortality:
None of the rats died during the study
Clinical signs:
Salivation was observed immediately after dosing
Body weight:
All animals showed normal weight gain during the study
Gross pathology:
No visible lesions were observed at terminal necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based upon the results of the Acute Oral Toxicity Limit Test in Rats, the acute oral LD 50 proved to be greater than 5000 mg/kg.