Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: The data from the migrated NONS file is deficient, and the study has not be seen to confirm reliability. No data is provided on the guidelines followed or if the study was performed to GLP standards, so the study could be highly unreliable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
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

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 given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA

Test animals

Species:
rat
Strain:
Wistar
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
Type of inhalation exposure (if applicable):
not specified
Remarks:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Vehicle:
other: Distilled water w/0.5% Cremophor.
Details on exposure:
Method of administration or exposure: gavage
Details on analytical verification of doses or concentrations:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Details on mating procedure:
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
Duration of test:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
0 mg/kg or mg/l
Basis:
no data
Remarks:
Doses / Concentrations:
50 mg/kg or mg/l
Basis:
no data
Remarks:
Doses / Concentrations:
200 mg/kg or mg/l
Basis:
no data
Remarks:
Doses / Concentrations:
800 mg/kg or mg/l
Basis:
no data
No. of animals per sex per dose:
25 animals per sex per dose
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

Examinations

Maternal examinations:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Ovaries and uterine content:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Fetal examinations:
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
Indices:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Historical control data:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:yes. Remark: Some effects - as detailed below.

Details on maternal toxic effects:
At 800 mg/kg bw, one dam died after the 7th and one after the 10th test article administration. The females of this group had marked clinical signs of reaction to treatment, reduced food consumption, slight body weight loss during the first day of dosing and reduced corrected body weight gain.

At 50 or 200 mg/kg, no effects of treatment with the test article on the maternal parameters were evident.

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
ca. 200 mg/kg bw/day (nominal)
Based on:
other: Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:yes. Remark: Some effects - as detailed below.

Details on embryotoxic / teratogenic effects:
Effects on fetus - Gross: At 800 mg/kg bw, the mean fetal bod weight was reduced. At 50 or 200 mg/kg bw, no effects of treatment with the test article on the fetal parameters wer evident.

Effects on fetus - Skeletal:
At 800 mg/kg bw, there was delay of skeletal ossification.

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
ca. 200 mg/kg bw/day (nominal)
Based on:
no data
Remarks:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Basis for effect level:
other: embryotoxicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The NOAEL is 200 mg/kg bw/day.
Executive summary:

The guideline followed has not been given in the migrated NONS file provided by ECHA. The study finds that the NOAEL for N-(n-octyl)-2 -pyrrolidinone is 200 mg/kg bw/day. This level is not low enough for classification of n-(n-octyl)-2 -pyrrolidinone.