Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

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:
Gro 266
Batch No.: GRO-RN-98810-003
SAT 080010

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: The gauze patch was applied to the intact skin of the clipped area.
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
0.5 g test item moistened with approximately 0.5 ml sterile water
Duration of treatment / exposure:
4 hour(s)
Observation period:
1, 24, 48, 72 hours
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hour
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 hour
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
other: animal #2 and animal #3
Time point:
other: 24 hour
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hour
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hour
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based upon the referred classification on criteria (Commission Directive 2001/59/EC of August 2001), GRO 266 is considered to be "not irritating" torabbit skin.
Executive summary:

The primary skin irritation potential of GRO 266 was investigated according to OECD test guideline no. 404 . The moistened test item was applied by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 0.00, 0.33 and 0.33, respectively and the mean oedema score was 0.00 for all three animals.

The application of GRO 266 to the skin resulted in mild signs of irritating including slight erythema. This effect was reversible and was no longer evident 48 hours after treatment in all animals. A light yellow staining produced by the test item was noted in one animal 1 hour after treatment.

No corrosive effect were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.

Thus the test item did not induce significant or irreversible damage to the skin.

Based upon the reffered classification criteria (Commission Directive 2001/59/EC of August 2001), GRO 266 is considered to be "not irritating" to rabbit skin.