Registration Dossier

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:
other: No analytical certificate (no data on batch number and expiry date of the test substance), no data on GLP and experimental conditions. The very high tested dose enables a reliable conclusion.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Federal Hazardous Substance Act.
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Laboratory Supply Company, Indianapolis, Indiana
- Weight at study initiation: 200 to 275 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
10 mL/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Preliminary study:
Yes, but results were not indicated.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 mL/kg bw
Based on:
test mat.
Mortality:
2 males and 1 female were found dead.
Clinical signs:
No clinical signs were observed.
Body weight:
No data
Gross pathology:
No gross abnormalities were noted at necrospy.

Applicant's summary and conclusion

Interpretation of results:
other: inconclusive
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The LD50 was expressed in mL/kg. The volume mass of the substance is 0.96 kg/L (0.96 g/mL). Therefore, when treating rats with 10 mL/kg, rats received 9.6 g/kg of substance, lowest limit of the LD50.