Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
other: Summary of study results
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
No guideline specified, but from available information it can be concluded that it has been conducted similar to OECD 401.
GLP compliance:
no
Remarks:
Study conducted prior to GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeder Winkelmann
- Weight at study initiation: 160-180 g
- Housing: 5 animals per cage

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
poloxamer
Remarks:
Lutrol
Doses:
0.5 g/kg, 0.6 g/kg, 0.7 g/kg, 0.8 g/kg and 1.0 g/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
700 mg/kg bw
Based on:
test mat.
Mortality:
0.5 g/kg group: 0/10
0.6 g/kg group: 2/10
0.7 g/kg group: 6/10
0.8 g/kg group: 7/10
1.0 g/kg group: 10/10
Clinical signs:
Sedation, dyspnoea, quivering spasms

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Although the documentation is not sufficient to assess the reliability of the study (Klimisch 4), the result should be considered regarding classification and the substance should be classified for safety reasons based on this result in the absence of any information which suggests the contrary. The determined LD50 value is 700 mg/kg bw, which would trigger a classification as acute toxic cat. IV according to Regulation (EC) No. 1272/2008, but due to the insufficient documentation, the reliability of the study and the results cannot be evaluated and hence, the study cannot be used for classification.
Executive summary:

In an acute oral toxicity study (no GLP) from 1978 groups of male rats (10/dose) were given oral doses of 0.5, 0.6, 0.7, 0.8 and 1.0 g/kg bw via gavage of the test substance and were observed for 14 days.

Result: oral LD50 = 7 g/kg bw