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Toxicological information

Skin irritation / corrosion

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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 labeling and/or risk assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

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 dated 2002.
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
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: 86%

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: 3033, 3167, 3044 g
- Housing: singly in stainless steel, wire-mesh cages suspended above cage boards
- Diet (e.g. ad libitum): 125 grams of rabbit food daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22ºC
- Humidity (%): 30-70%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent areas of untreated skin were used for comparison.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 m/L
Duration of treatment / exposure:
4 hours
Observation period:
up to 72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approximately 6 cm2
- % coverage: 100
- Type of wrap if used: 2-ply gauze pad which was held in place with non-irritating tape and the trunk of each rabbit was wrapped with porous tape and further secured with waterproof tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently washed with warm water to remove excess test substance and gently patted 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:
mean
Time point:
other: 0 minutes to 72 hours
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 0 minutes to 72 hours
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Erythema (score of 1 or 2) but no edema was observed in the 3 rabbits on the day of dosing. No dermal irritation was observed at 24, 48/50, or 72 hours after removal of the test substance. No clinical signs were observed, and no body weight loss occurred. See Table 1 below.

Any other information on results incl. tables

Table 1: Dermal Responses Observed in Individual Rabbits

ERYTHEMA

Rabbit

Number

Evaluation after Removal of Test Substance

0 Minutes

60 Minutes

24 Hours

48 Hours

72 Hours

264

2

2

0

0

0

275

--

2

0

0

0

276

--

1

0

0

0

 

EDEMA

Rabbit

Number

Evaluation after Removal of Test Substance

0 Minutes

60 Minutes

24 Hours

48 Hours

72 Hours

264

0

0

0

0

0

275

--

0

0

0

0

276

--

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
other: no classification is required
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the test substance produced erythema, which cleared by 24 hours, when applied to the skin of rabbits. I
This study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability).
Executive summary:

The test substance was applied as a single 0.5-mL dermal dose to the shaved intact skin of a single New Zealand White rabbit. Since no corrosion occurred, 2 additional rabbits were treated. The test substance was applied to a 6 cm² area of skin. The application area was covered with a 2-ply gauze square which was held in place with non-irritating tape and covered with porous tape for a semi-occlusive dressing. The rabbits were exposed to the test substance for 4 hours after which the test substance was removed. Test sites were evaluated and scored by the method of Draize for signs of dermal irritation approximately 60 minutes, and 24, 48/50, and 72 hours after test substance removal. The rabbit that was initially treated was also examined immediately after test substance removal. Erythema (score of 1 or 2) but no edema was observed in the 3 rabbits on the day of dosing. No dermal irritation was observed at 24, 48/50, or 72 hours after removal of the test substance. No clinical signs were observed, and no body weight loss occurred. Under the conditions of this study, the test substance produced erythema, which cleared by 24 hours, when applied to the skin of rabbits.