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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
Study period:
28 June 2005 to 10 August 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study meets or exceeds the requirements of OECD Guideline 404 and EU Method B.4

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
A gauze patch of approximately 4 cm x 4 cm (instead of 6 cm2) was used to guarantee good contact and uniform distribution of the test substance on the skin
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
as above
GLP compliance:
yes (incl. certificate)
Remarks:
Study in compliance with Swiss Ordinance relating to GLP, which is based on OECD Principles of GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Animal specifics: SPF
- Source: Charles River Laboratories, L'Arbresle, France
- Age at study initiation: 12 weeks (male), 12-13 weeks (females)
- Weight at study initiation: 2741 g for the male, 2873 g and 2674 g for the two females, all within the normal range of variability
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet (e.g. ad libitum): standard laboratory diet ad libitum
- Water (e.g. ad libitum): community tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C (air-condition)
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml of purified water were used to moisten the test item
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approximately 4 cm x 4 cm
- Type of wrap if used: surgical gauze patch

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

SCORING SYSTEM:
as in EU Method B.4, assessed approximately 1, 24, 48, and 72 h after the romoval of the test item as well as after 7, 10 and 14 d

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours after application
Score:
0.11
Max. score:
4
Reversibility:
fully reversible within: 48 h after treatment
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours after application
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effects
Irritant / corrosive response data:
Apart from animal #2 at 24 h, all other scores (oedema or erythema) were 0 at all time points in all animals (see below for individual data).
Other effects:
No clinical signs or effects on body weight were observed. Erythema scores could not be assessed in all animals at 1 h due to marked staining produced by the test item

Any other information on results incl. tables

Animal number

Sex 

Evaluation interval (after removal of dressing )

Erythema score

Oedema score 

#1

1 hour 

not assessible due to staining

#2

F

0

#3

F

0

#1 

24 hours

0

#2

F

1

0

#3

F

0

0

#1

M

48 hours

0

0

#2

F

0

0

#3

F

0

0

#1

M

72 hours 

0

0

#2

F

0

0

#3

0

0

#1

M

7 days 

0

0

#2

F

0

0

#3

F

0

0

#1

M

10 days

0

0

#2

F

0

0

#3

F

0

0

#1

M

14 days

0

0

#2

F

0

0

#3

F

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
According to the classification criteria of Regulation (EC) No 1272/2008 the test item is not irritating to skin under these test conditions. The test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

The primary skin irritation potential of the test item was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the dressing.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 0.00, 0.33 and 0.00, respectively and the mean oedema score was 0.00 for all three animals.

The application of the test item to the skin resulted in mild, early-onset and transient signs of irritation such as erythema. These effects were reversible and were no longer evident 48 hours after treatment for all animals. However, staining prevented the assessment of a possible erythema in all animals one hour after treatment. The slight to marked staining of the treated skin was noted in all animals throughout the whole study, effectively. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.

Thus, the test item did not induce significant or irreversible damage to the skin.

Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.