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: OECD guideline, GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
• Identification, reference : UG batcli 97302300
• Appearance : white solid (pieces)
• Quantity received, packaging: 100 g, plastic box
• Date ofreceipt : November 10, 1997
• Laboratory reference: 97-369 1
• Analytical sheet: not supplied
• Homogeneity test: not required for less than 28 days studies
• Storage: at room temperature, away from the light and heat

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
- Species, strain, supplier : New-zealand albino rabbit, Charles RIVER (76110 Saint Aubin
Les Elbeuf France).
Reason for species selection : the New-zealand albino rabbit is the animal traditionally used for the evaluation of irritant potential of products and is the animal chosen by the regulatory authorities.
- Number and sex: 3 females
If strong effects are foreseeable, the test is performed in one animal. From the results obtained, the test may be flot realized in the two others.
- Average weight: 2.4 kg
- Identification: auricular ring
- Acclimatization : at ieast 5 days
- Housing, diet : environmental conditions and controls in accordance with the requirements of the 86/609/EEC guideline (individuai housing on floor grid). Complete peileted rabbit maintenance diet ERGILAP Anco, COFNA (37018 - TOURS, FRANCE).
- Preparation: approximately 24 hours before the test, fur is removed by clipping from the dorsal area of the trunk of the animais. Care is taken to avoid abrading the skin. Only animais with heaithy intact skin are used.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
14 days
Number of animals:
3
Details on study design:
The test material is applied under a semi-occlusive patch to the skin of the 3 rabbits at the dose of 0.5 g!rabbit according to the foilowing procedure
• 0.5 mi ofthe test material (previously pounded in a mostar) are appiied to the ciipped skin, then covered with a gauze (2.5 x 2.5 cm) heid in place by means of a 5 x 5 cm wide “Micropore” fastening tape. Then the animais trunk is wrapped with a 10 cm wide stretch tape (varicose vein tape) fastened by adhesive tape of the same width, place in such a way so as flot to hinder respiratory movements.
• the rabbits are returned to their cages for 4 hours at the end of which the dressing and the gauze patch are removed. Then, residuai test substance is removed, using absorbent paper moistened with distiiled water.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Max. score:
1
Remarks on result:
other: Max. duration: 1 d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Under the experimental conditions adopted, the application of the substance UG batch 97302300 for 4 hours to the skin of the rabbit, produced, 1 hour after patch removal, the formation of a slight erythema in 1 rabbit and a slight oedema in another one. No cutaneous reactions were seen on the last animal. During the first 72 hours, erythematous and oedematous reactions had disappeared in both of them.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the 67/548/EEC order classification, the substance UG batch 97302300 is unclassified among the substances irritating to skin.
Executive summary:

The application of 0.5 ml of the substance UG batch 97302300 for 4 hours under a semi-occlusive patch to the skin of 3 rabbits, produced, one hour after patch removal, a slight erythema in 1 animal and a slight oedema in another one. The third rabbit did flot exhibit any cutaneous reaction. During the 72 following hours, irritation reactions had totally disappeared.

According to the 671548/EEC order classification, the substance UG batch 97302300 is unclassified among the substances irritating to skin.