Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Remarks:
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
Principles of method if other than guideline:
A guideline has been followed.
GLP compliance:
yes
Type of study:
other: Not stated in information from migrated NONS file as per inquiry # [06-0000024772-67-0000]. Permission to refer granted by ECHA

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(n-octyl)-2-pyrrolidinone
EC Number:
403-700-8
EC Name:
N-(n-octyl)-2-pyrrolidinone
Cas Number:
2687-94-7
Molecular formula:
C12H23NO
IUPAC Name:
N-(n-octyl)-2-pyrrolidinone
Details on test material:
Not stated in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
Not stated in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Epicutanious
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal induction: 0.05 %
Epidermal induction: 30 %
Concentration of test substance and vehicle used for each challenge: 10 and 5 %
Challengeopen allclose all
Route:
other:
Vehicle:
other: Epicutanious
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal induction: 0.05 %
Epidermal induction: 30 %
Concentration of test substance and vehicle used for each challenge: 10 and 5 %
No. of animals per dose:
No. of animals in test group: 20
No. of animals in negative control group: 10
Details on study design:
controls were challenged with the same test item concentration as the test animals
Challenge controls:
Controls were challenged with the same test item concentration as the test animals

Study design: in vivo (LLNA)

Concentration:
Not applicable, test was not LLNA
No. of animals per dose:
Not applicable, test was not LLNA
Details on study design:
Not applicable, test was not LLNA
Statistics:
Not applicable, test was not LLNA

Results and discussion

Positive control results:
Not stated in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Not applicable, test was not LLNA
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Not applicable, test was not LLNA

Any other information on results incl. tables

Evidence of sensitisation of each challenge concentration: The dermal reactions seen in two test animals were more marked than those seen in the controls. The dermal response seen in the remaining eighteen animals was similar to that seen in the controls.

The summary provided by ECHA states that this is an LLNA method, however based on the results and information given it appears to be an M&K method.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
N-(n-octyl)-2-pyrrolidinone is not a skin sensitiser
Executive summary:

An annex V guideline has been followed. N-(n-octyl)-2 -pyrrolidinone is found not to be a skin sensitiser.