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: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Remarks:
The study was conducted according to the guideline in effect at the time of study conduct.
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Remarks:
The study was conducted according to the guideline in effect at the time of study conduct.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
-Purity: 97.6%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: Not reported
- Weight at study initiation: 2734-3108 g
- Housing: Singly in suspended, stainless steel, wire-mesh cages
- Diet (e.g. ad libitum): 125 g rabbit chow daily, except for approximately 24 hours when in stocks
- Water (e.g. ad libitum): ad libitum, except for approximately 24 hours when in stocks
- Acclimation period: Approximately 2 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±2°C
- Humidity (%): 50±10%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: Adjacent areas of untreated skin were used for comparison.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
24 hours
Observation period:
1, 24, 48, and 72 hours after test substance removal
Number of animals:
2 female and 1 male
Details on study design:
TEST SITE
- Area of exposure: Scapular to lumbar region of the back
- % coverage: Not reported
- Type of wrap if used: A 2-inch gauze square was placed over the test site. The patch was held in place with non-irritating tape. Rubber sheeting was then wrapped around the animals and secured with clips.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were gently washed with Ivory® soap and warm water and gently wiped dry.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: range
Time point:
other: 1 hour to 72 hours
Score:
0 - 1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
other: range
Time point:
other: 1 hour to 72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
No irritation was observed in any rabbit by 1 hour after patch removal. By 24 hours, 1 rabbit exhibited slight erythema, which cleared by 48 hours. No other dermal irritation was observed throughout the study.

Any other information on results incl. tables

Table 1: Individual Animal Dermal Effects

ERYTHEMA

Rabbit Number

Evaluation after Removal of Test Substance

1 Hour

24 Hours

48 Hours

72 Hours

27900

0

0

0

0

27901

0

0

0

0

28034

0

1

0

0

 

EDEMA

Rabbit Number

Evaluation after Removal of Test Substance

1 Hour

24 Hours

48 Hours

72 Hours

27900

0

0

0

0

27901

0

0

0

0

28034

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EEC Directive 91/325
Conclusions:
The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability). No dermal irritation was observed in any rabbit by 1 hour after patch removal. By 24 hours, 1 rabbit exhibited slight erythema which cleared by 48 hours.
Executive summary:

The test substance was evaluated for acute skin irritation potential in 1 male and 2 female New Zealand White rabbits. Approximately 0.5 mL was administered to a localized test site on the back of each animal. The test sites were covered with a semi-occlusive dressing to ensure contact between the skin and test substance. The animals were exposed to the test substance for 4 hours. The test sites were evaluated and scored according to a numerical scale, 1, 24, 48, and 72 hours after the end of the 4-hour exposure period. No dermal irritation was observed in any rabbit by 1 hour after patch removal. By 24 hours, 1 rabbit exhibited slight erythema which cleared by 48 hours.