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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: The data in the migrated NONS file is deficient and the study has not been seen to confirm quality.

Data source

Reference
Reference Type:
other: Body respondible for the test
Title:
Unnamed
Year:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: The method used was a modification of that described by J.H. Draize.
Principles of method if other than guideline:
The method used was a modification of that described by J.H. Draize.
GLP compliance:
yes
Test type:
other: Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Remarks:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Details on dermal exposure:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 males, 3 females
Control animals:
not specified
Details on study design:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Statistics:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA

Results and discussion

Preliminary study:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
not specified
Remarks:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Remarks on result:
other: 95% Cl and Based on data not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Mortality:
No deaths to any animals throughout study
Clinical signs:
Signs of toxicity related to dose levels: no mortality
Body weight:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Gross pathology:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Other findings:
Signs of toxicity (local): No dermal changes observed in any animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
N-(n-octyl)-2-pyrrolidinone is not classified with regards to dermal toxicity.
Executive summary:

The study does not follow a clear guideline. The LD50 value of N-(n-octyl)-2 -pyrrolidinone is found to be >2000 mg/kg bw. The findings are that N-(n-octyl)-2 -pyrrolidinone is not classified with regards to dermal toxicity.