Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16th to 19th September 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Proprietary study conducted according to guidelines and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
e-Caprolactone, a liquid, was supplied by Solvay S.A. Brussels. Batch No: WA2809/0791. Purity: >99%. Prior to dosing, the substance was stored in a refrigerator.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Three SPF-derived male New Zealand White rabbits (2.5-3.0kg) were obtained from Harlan Olac and acclimatised for 11 days. The rabbits were individually housed in stainless steel wire cages; sawdust, woodchip, or any other extraneous material that may cause skin irritation were excluded. The rabbits received 80g standard laboratory diet per day, and they had free access to the food and water. The animal room was maintained at a temperature of 19-20oC, relative humditiy 55-72%, artificial light from 7am till 7pm, radio-sound from 7am till 7pm, and approximately 16 air changes per hour.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5g of test material 2x3cm area of skin.
Duration of treatment / exposure:
The patches were secured in place for 4 hours.
Observation period:
Observations were made at 30-60 minutes, and 24, 48 and 72 hours after substance removal.
Number of animals:
Three male rabbits.
Details on study design:
Areas on the backs of 3 rabbits were shaved (2x3cm). 0.5g e-Caprolactone was applied directly to the shaved skin, and held in place by occlusive Blenderm tape and standard adhesive tape. Elizabethan collars were fitted to the rabbits to prevent them disturbing the treatment area. The substance was left in place for 4 hours. Following this the collars and tape were removed, and the skin wiped to remove any remaining residue. Observations were made at 30 minutes, and 24, 48 and 72 hours after substance removal.
Treatment sites were scored based on erythema and eschar formation, and oedema formation (according to the scoring system in OECD 404).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: No effects noted
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: No effects noted
Irritant / corrosive response data:
No erythma or oedema was observed in the three rabbits after 4 hours skin exposure to e-Caprolactone.
Other effects:
No other effects reported.

Any other information on results incl. tables

No erythma or oedema was observed in the three rabbits after 4 hours skin exposure to e-Caprolactone, at any time point post-substance removal.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The application of e-Caprolactone caused no irritation to the shaven intact skin of 3 rabbits, therefore the substance was classified as non-irritant according to EEC labelling regulations.
Executive summary:

The primary irritation of e-Caprolactone to rabbit skin was investigated. 0.5 g e-Caprolactone was applied directly to an area of shaved skin on the backs of the rabbits (2x3cm), and held in place for 4 hours using occlusive tape. After removal of the tape the skin was wiped to remove any remaining residue, and observations were made at 0.5, 24, 48 and 72 hours after removal. No erythema or oedema was observed in the rabbits at any time point. Classification as a skin irritant is not required on the basis of this study.