Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Remarks:
Study in animals performed before Annex VII and VIII amendments.
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1960
Report Date:
1960

Materials and methods

Principles of method if other than guideline:
BASF-Test. See details in remarks on material and methods
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): γ-Butyrolacton
- Physical state: colorless liquid
- Analytical purity: 99.5 %

Test animals

Species:
rabbit
Strain:
Vienna White

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin site of the same animal served as control
Duration of treatment / exposure:
1 min, 5 min, 15 min or 20 h
Observation period:
8 days
Number of animals:
2

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: no symptoms
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no symptoms
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no symptoms
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no symptoms

Any other information on results incl. tables

Undiluted gamma-butyrolactone caused only very slight erythema on the day of application after a 1 min, 5 min, 15 min exposure. The 20 h exposure caused no observed effects.

Applicant's summary and conclusion

Interpretation of results:
not irritating