Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28.8.2001 - 14.9.2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
(S)-pyrrolidine-2-carboxamide
EC Number:
231-397-0
EC Name:
(S)-pyrrolidine-2-carboxamide
Cas Number:
7531-52-4
Molecular formula:
C5H10N2O
IUPAC Name:
(S)-pyrrolidine-2-carboxamide

Test animals

Species:
rabbit
Strain:
other: New Zealand Albino rabbits

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
A sample was moistened with the smallest amount water for injection, needed to ensure good contact with the skin.
Controls:
no
Duration of treatment / exposure:
4 h
Observation period:
72 h
reading time points: 1, 24, 48 and 72 h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 0
Reversibility:
other: reversibility: not applicable
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Positive skin reaction (erythema, score 1) was detected in one animal at the 1 h reading. This effect was reversible within 24 h after removing the test substance. Two other animals were without any skin reaction. No other signs of intoxication were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified