N-(n-octyl)-2-pyrrolidinone

Skin sensitisation

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

Test material information

Constituent 1

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)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

other: Epicutanious

Induction 2

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 %

Challenge

Challenge 1

Route:

other:

Vehicle:

other: Epicutanious

Challenge 2

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)

Results

Results 1

Parameter:

SI

Remarks on result:

other: Not applicable, test was not LLNA

Results 2

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.