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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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
other: EEC Methods for the Determination of Toxicity Method B.4 Directive 92/69/EEC
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: not reported as such

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: 3001, 2416, 2447 g
- Housing: singly in stainless steel, wire-mesh cages suspended above cage boards; enrichment (e.g., toy) was placed in each cage
- Diet (e.g. ad libitum): approximately 125 grams of Rabbit LabDiet daily during the study
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
Approximately 4 hours.
Observation period:
Approximately 60 minutes after removal of the test patches, and approximately 24, 48, and 72 hours after removal of the patches.
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 held in place with non-irritating tape. The trunk of each rabbit was wrapped with porous tape. The tape was 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: Approximately 4 hours after application.

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
Irritation parameter:
edema score
Basis:
other: range
Time point:
other: 1 hour to 72 hours
Score:
0
Irritant / corrosive response data:
The rabbits exhibited no dermal irritation during the study. No clinical signs of toxicity were observed in any of the rabbits during the study and no body weight loss occurred. The dermal scores from individual animals with respect to observation time are presented in Table 1.

Any other information on results incl. tables

Table 1

Dermal Responses Observed in Individual Rabbits

Rabbit

Number

Evaluation after Removal of Test Substance

Erythema

Edema

0 Min

60 Min.

24 Hrs

48 Hrs

72 Hrs

0 Min

60 Min.

24 Hrs

48 Hrs

72 Hrs

230a

326

332

0

--

--

0

0

0

0

0

0

0

0

0

0

0

0

0

--

--

0

0

0

0

0

0

0

0

0

0

0

0

a Initial Rabbit Tested

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the test substance produced no dermal irritation when applied to the skin of rabbits.
In accordance with the provisions of Directive 67/548/EEC, classification is not required based on the results of this study.
According to the Globally Harmonized System (GHS) of classification and labeling of chemicals and under the conditions of this study, classification is not required.
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 exhibited no dermal irritation during the study. No clinical signs of toxicity were observed, and no body weight loss occurred. Under the conditions of this study, the test substance produced no dermal irritation when applied to the skin of rabbits.