Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non GLP (performed 1988), only summary report, acceptable because no mortality occured

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Body weight not controlled. No information on housing conditions.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): TK 12340
- Lot/batch No.: EN-127 506.82
Specific details on test material used for the study:
- Lot/batch No.: EN-127 506.82

Test animals

Species:
rat
Strain:
other: albino
Sex:
male/female

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality occurred
Mortality:
No mortality was observed.
Clinical signs:
Piloerection, abnormal body positions, and dyspnea were seen, being common symptoms in acute toxicity testing. The animals recovered within 9 days.
Gross pathology:
No adverse findings noted.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance caused no mortality when administered dermally at a single dose of 2000 mg/kg bw to the albino rat.