Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Only limited information on the test material are available.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
According to Guideline.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000, 3200, 4000, 5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 100 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 870 mg/kg bw
Based on:
act. ingr.
Mortality:
There were deaths among animals dosed at 4000 and 5000 mg/kg bw.
Clinical signs:
Signs of reaction to treatment observed in all rats that survived for more than one hour after dosing were piloerection, hunched posture, abnormal gait (waddling), lethargy and diarrhoea. These were accompanied by:
- decreased respiratory rate and pallor of the extremities in all rats that survived for more than one hour after dosing at 3200 mg/kg bw and above,
- ptosis in all rats that survived for more than one hour after dosing at 4000 mg/kg bw and above,
- increased salivation in all rats dosed at 3200 mg/kg bw.
Body weight:
No effects.
Gross pathology:
No effects.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.