Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 403-700-8 | CAS number: 2687-94-7 NOP; SURFADONE LP-100 SURFACTANT
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: 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 respondible for the test
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: The method used was a modification of that described by J.H. Draize.
- Principles of method if other than guideline:
- The method used was a modification of that described by J.H. Draize.
- GLP compliance:
- yes
- Test type:
- other: Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
- Limit test:
- no
Test material
- 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
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- 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
- Type of coverage:
- occlusive
- Vehicle:
- not specified
- Remarks:
- Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
- Details on dermal exposure:
- Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 males, 3 females
- Control animals:
- not specified
- 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:
- > 2 000 mg/kg bw
- Based on:
- not specified
- Remarks:
- Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
- Remarks on result:
- other: 95% Cl and Based on data not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
- Mortality:
- No deaths to any animals throughout study
- Clinical signs:
- Signs of toxicity related to dose levels: no mortality
- 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:
- Signs of toxicity (local): No dermal changes observed in any animals.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- N-(n-octyl)-2-pyrrolidinone is not classified with regards to dermal toxicity.
- Executive summary:
The study does not follow a clear guideline. The LD50 value of N-(n-octyl)-2 -pyrrolidinone is found to be >2000 mg/kg bw. The findings are that N-(n-octyl)-2 -pyrrolidinone is not classified with regards to dermal toxicity.
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