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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
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:
other: Body responsible for the test
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: The methods described by Hagan E.C. served as a guide
Principles of method if other than guideline:
A guideline has been followed
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

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:
rat
Strain:
Wistar
Sex:
male/female
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:
other: Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Vehicle:
other: Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Details on oral exposure:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Doses:
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:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Control animals:
other: Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
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
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

Preliminary study:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 050 mg/kg bw
Mortality:
Male: 630 mg/kg bw; No. of animals: 5; No. of deaths: 0
Male: 1000 mg/kg bw; No. of animals: 5; No. of deaths: 0
Male: 1580 mg/kg bw; No. of animals: 5; No. of deaths: 2
Male: 2520 mg/kg bw; No. of animals: 5; No. of deaths: 0
Male: 5000 mg/kg bw; No. of animals: 5; No. of deaths: 4
Female: 630 mg/kg bw; No. of animals: 5; No. of deaths: 1
Female: 1000 mg/kg bw; No. of animals: 5; No. of deaths : 3
Female: 1580 mg/kg bw; No. of animals: 5; No. of deaths: 1
Female: 2520 mg/kg bw; No. of animals: 5; No. of deaths: 1
Female: 5000 mg/kg bw; No. of animals: 5; No. of deaths: 5
Clinical signs:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Body weight:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Gross pathology:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Other findings:
Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 of N-(n-octyl)-2-pyrrolidinone is 2050 mg/kg bw.
Executive summary:

The methods followed have been described by Hagan E.C.. They result in an acute oral LD50 of 2050 mg/kg bw, meaning that N-(n-octyl)-2 -pyrrolidinone is not classified.