Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study performed under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
gas under pressure: refrigerated liquefied gas
Details on test material:
- Physical state: Colorless to pale yellow liquid
- Storage condition of test material: In a refrigerator at ca. 4 °C.
- Other: Stability of test article: Stable at storage conditions; Safety precaution: Gloves, goggles and face mask were sufficient to assure personnel health and safety.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: 15 weeks
- Weight at study initiation: 2809 - 3039 g
- Housing: Individually in stainless steel cages with an automatic cleaning system equipped with feed hoppers, drinking water bowls, with wood and haysticks for gnawing.
- Diet (e.g. ad libitum): Certified pellet diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod: 12 hour light / 12 hour dark

IN-LIFE DATES: From: 13/10/98 To: 22/10/98

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
Duration of treatment / exposure:
4 hours
Observation period:
3 days
Number of animals:
3 animals (1 male; 2 females)
Details on study design:
TEST SITE
- Area of exposure: dorsal area
- % coverage: 6 sq. cm (2.5 cm x 2.5 cm)
- Type of wrap if used: semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Flushed with lukewarm tap water.
- Time after start of exposure: 4 hours

SCORING SYSTEM: The skin reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours after the removal of the dressing, gauze patch and test article.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
8
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
4
Remarks on result:
other: mean of all 3 organisms
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
4
Remarks on result:
other: mean of all 3 organisms
Irritant / corrosive response data:
Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No signs of irritation were observed. No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.
Other effects:
No staining by the test article of the treated skin was observed. No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test material is considered to be not irritating to the skin.
Executive summary:

The study was performed EU Method B.4 and OECD 404 guideline in accordance with GLP to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. A dose of 0.5 ml test substance (undiluted), was applied to the intact clipped dorsal skin site under a semi-occlusive dressing for 4 hours. The patch was then removed and the application site was washed to remove residual test material. Skin observations were made 1, 24, 48 and 72 hours after patch removal. A single 4-hour, semi-occluded application of the test material to the intact skin produced no irritation effects. The test material produced a primary irritation index (PII) of 0 and is considered to be non-irritating to skin. No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.