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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: A guideline has been followed and the study is GLP compliant. However, the data in the migrated NONS file is deficient, and the study has not been seen to confirm quality.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V with modifications (see overall remarks)
Principles of method if other than guideline:
A guideline has been followed
GLP compliance:
yes

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
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

Test system

Type of coverage:
occlusive
Preparation of test site:
other: Not stated in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Vehicle:
unchanged (no vehicle)
Controls:
other: Not stated in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Amount / concentration applied:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Score:
3.9
Remarks on result:
other: Max. duration: d; Max. value at end of observation period:
Irritation parameter:
edema score
Basis:
mean
Score:
3.5
Remarks on result:
other: Max. duration: d; Max. value at end of observation period:
Irritant / corrosive response data:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Other effects:
There were no appreciable differences in the severity of the reaction on abraded and non-abraded skin. In addition to erythema and oedema, skin blanching was seen at 24 hours.
The severity of the reaction increased up to 72 hours, at which point all animals showed crusting indicative of corrosion. It would appear that the study was terminated at 72 hours.

Any other information on results incl. tables

No further information

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information
Conclusions:
N-(n-octyl)-2-pyrrolidinone is corrosive, R34
Executive summary:

An annex V guideline has been followed. N-(n-octyl)-2-pyrrolidinone is corrosive, R34.