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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
June 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Similar to OECD 401, a single dose of the substance was administered to rats by gavage
GLP compliance:
no
Remarks:
Pre GLP.
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
SImilar Substance 01
IUPAC Name:
SImilar Substance 01
Test material form:
solid: particulate/powder
Remarks:
powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Number of animals: 10 (5 female and 5 male)
- Age at study initiation: 6- 7 weeks
- Weight at study initiation: 225 g (male), 190 g (female)
- Housing: singly caged
- Diet : commercial pelletted diet (added with vit.E) ad libitum
- Water : ad libitum for all test duration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C ± 2°
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
A 25 w/v i solution of the compound in deionised water was administered as a single dose by gavage to rats which had been fasted for 18 hours
Doses:
Dose rate of 20ml/kg (equivalent to 5g/kg. compound)
Details on study design:
- Duration of observation period following administration: 14 days
- Other observation: clinical symptoms
- Autopsy performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No death
Clinical signs:
other: No clinical symptoms
Gross pathology:
No change in organs or tissue

Applicant's summary and conclusion

Interpretation of results:
other: Not clasified as toxic or harmful according to CLP Regulation (EC) No. 1907/2006.
Conclusions:
The acute oral median lethal dose LD50 in rats is > 5000 mg/kg body weight.
No clinical symptoms were recorded and no deaths occurred during the 14 day observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.
Executive summary:

The determination of oral toxicity of the substance was determined in an, but no guideline is available and the test was not performed on GLP. The test substance was tested in a single dose (5000 mg/kg bw) on rats. The animals were observed for 14 days.

The acute oral median lethal dose LD50 in rats in > 5000 mg/kg body weight.

No clinical symptoms were recorded and no deaths occurred during the 14 day observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.