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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005
Reference Type:
other: Amendment
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1-ethylpyrrolidin-2-one
EC Number:
220-250-6
EC Name:
1-ethylpyrrolidin-2-one
Cas Number:
2687-91-4
Molecular formula:
C6H11NO
IUPAC Name:
1-ethylpyrrolidin-2-one
Details on test material:
purity: 99.8 corr. area-%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Female animals were nulliparous and non-pregnant. Individual identification by cage cards and tail marking. The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 - 24°C for temperature and of 30 - 70% for relative humidity. There were no deviations from these ranges, which influenced the results of the study. Day/night rhythm: 12h/12h. Stainless steel wire mesh cages were used and the animals were housed singly. Diet was Kliba-Labordiät, water was available ad libitum. Acclimatization for at least 5 days. Clipping of the fur about 24 hours before the beginning of the study.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The test material was applied to the clipped skin (dorsal and dorsolateral parts of the trunk). Application area about 40 cm2 (corresponds to at least 10% of the body surface).
Observation period at least 14 days. Body weight determination: Individual body weights shortly before application (day 0), weekly thereafter and at the end of the study.
Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals. Scoring of skin findings: Individual readings 30 - 60 minutes after removal of the semiocclusive dressing (day 1), as a rule weekly thereafter and at the end of the study (last day of the observation period). A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays. Gross-pathology examination on the last day of the observation period after killing with CO2.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred
Clinical signs:
other: No systemic clinical observations were observed during clinical examination. No local effects were observed.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined at termination of the study.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU