Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Tyhe migrated NONS file provided by ECHA is deficient. No guideline is specified, and it is not stated whether or not GLP standards were followed. However, the study has been accepted by ECHA previously, so it can be assumed that it was compliant with the guidelines at the time.

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: Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Principles of method if other than guideline:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
GLP compliance:
not specified
Remarks:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Type of assay:
micronucleus assay

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
Test material form:
not specified
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:
mouse
Strain:
not specified
Sex:
not specified
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

Route of administration:
oral: unspecified
Vehicle:
Corn oil
Details on exposure:
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:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Frequency of treatment:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Post exposure period:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Doses / concentrations
Remarks:
Doses / Concentrations:
1720 mg/kg
Basis:
no data
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
No. of animals per sex per dose:
Five male, five female
Control animals:
not specified
Positive control(s):
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA

Examinations

Tissues and cell types examined:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Details of tissue and slide preparation:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Evaluation criteria:
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

Test results
Sex:
male/female
Genotoxicity:
not specified
Remarks:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Toxicity:
yes
Remarks:
Doses producing toxicity: LD50 = 2843 m,g/kg bw; LD10 over 72 hour exposure period =1720 mg/kg bw
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
Observations:
There was no significant increase in the frequency of micronucleated polychromativ erythrocytes.
There was no significant decrease in the ratio of polychromatic to normochromatic erythrocytes after treatment.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
N-(n-octyl)-2-pyrrolidinone does not exhibit any genetic toxicty.
Executive summary:

A specific guideline has not been followed. However, the results show that no genotoxicity is echibited, meaning that N-(n-octyl)-2 -pyrrolidinone is not classified.

The study is considered as viable data, as the will is to not repeat any studies on animals, in accordance with regulation 1907/2006/EC.