Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April / May 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

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)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
other: CFY
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 100 - 118 g
- Fasting period before study: the rats were starved overnight before treatment with test item

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: the substance was prepared as a 30% aqueous suspension
- Amount of vehicle: dosage volume of 16.7 ml/kg bodyweight.

Doses:
5000 mg/kg b.w
No. of animals per sex per dose:
10 males per dose
Control animals:
yes
Remarks:
rats treated with water alone (16.7 ml/kg)
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: all rats were examined macroscopically in an attempt to identify any target organs.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no mortalities
Clinical signs:
Slight to moderate lethargy, pilo-erection, diarrhoea and solivation
Body weight:
Normal bodyweight increases, compared with controls.
Gross pathology:
No finding
Other findings:
Recovery of the treated rats, as judged by external appearance and behaviour, was apparently complete two days after the treatment.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
The LD50 to male rats was found to be greater than 5000 mg/kg bodyweight.
Executive summary:

The substance was tested for acute toxicity by oral route administration. Five male rats were tested at concentration of 5000 mg/kg b.w and other five male were used as vehicle control. No mortalities was registered. The LD50 to male rats was found to be greater than 5000 mg/kg bodyweight.