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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

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:
no further data

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
Stainless steel cages with an floor area of 40 x 51 cm were used. One animal per cage. 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. The day/night rhythm was 12 h dark and 12 h light. No bedding were used in the cages, saw-dust in the waste trays. Kliba 341 was used as diet and about 250 ml tap water per animal per day was available. Acclimatization period: at least 8 days before the beginning of the study; same housing conditions as during the study. The mean body weights were 2.77 kg for males and 3.11 kg for females.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
Wetting of the test patch with the undiluted substance, and thus about 0.5 ml of the test liquid is absorbed.
Duration of treatment / exposure:
4 h
Observation period:
30 - 60 min after removal of the test patches and 24 h, 48 h, 72 h, 8 d after the beginning of application
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 -72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
0

Any other information on results incl. tables

Readings   Animal No.  Intact Skin     Symptoms
    Erythema  Edema  
 4 hours  1  1  0  
   2  1  0  
   3  0  0  
 24 hours  1  2  0  
   2  1  0  
   3  1  0  
 48 hours  1  2  0  
   2  1  0  
   3  1  0  
 72 hours  1  2  0  
   2  1  0  
   3  1  0  
 8 days  1  0  0  scaling
 2 0  0  
   3  0  0  

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information