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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:
2010-01-20 till 2010-03-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-conform study under GLP without deviations

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- public name of test material : Coupling reaction on diazotized (aminonaphthalen)sulfonyl)ethanol polysulfanate with 6-chloro-N-ethyl-N-(3-(ethylsulfonyl)phenyl)-N'-naphthalen-1-yl-1,3,5-triazine polysulfonate, polyhydroxide, polyamine, sodium and potassium salts
- Substance type: textile dyestuff
- Physical state: red powder
- Analytical purity: ca. 63 % of all colored components
- Lot/batch No.: BOP 07-09
- Expiration date of the lot/batch: 2014-07-31
- Storage condition of test material: At room temperature at about 20 °C

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS Young Adult New Zealand White Rabbit, SPF
- Source: Charles River Deutschland GmbH Stolzenseeweg 32-36 88353 Kisslegg / Germany
- Age at study initiation: 13 weeks (male), 12 weeks (females)
- Weight at study initiation: 2587 g (male), 2888 - 3056 g (females)
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Haysticks and wood blocks were provided for gnawing.
- Diet: Pelleted standard Kliba Nafag 3418 rodent maintenance diet available ad libitum.
- Water: Community tap water from Füllinsdorf ad libitum.
- Acclimation period:20-Jan-2010 to 24-Jan-2010 (one female); 20-Jan-2010 to 25-Jan-2010 (one male and one female)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): relative humidity between 30-70% (values above 70% during cleaning process possible),
- Air changes (per hr): Air-conditioned with 10-15 air changes per hour
- Photoperiod: automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied : 0.5 g/animal

VEHICLE
- Amount(s) applied (volume or weight with unit): The test item was moistened with approximately 0.5 mL of purified water before application
Duration of treatment / exposure:
4h
Observation period:
14d
Number of animals:
1 male and 2 females
Details on study design:
TEST SITE
- Area of exposure: approximately 100 cm² (10 cm x 10 cm). Four days before treatment, the left flank was clipped with an electric clipper The skin of the animals was examined one day before treatment, and regrown fur of all animals was clipped again.
- % coverage: A surgical gauze patch (ca. 2.5 cm x 2.5 cm) held in contact with the skin by means of an adhesive hypoallergenic aerated semiocclusive dressing and a restrainer bandage wrapped around the abdomen.

REMOVAL OF TEST SUBSTANCE
After 4 hours exposure time, the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site.

SCORING SYSTEM:
The skin reaction was assessed according to the numerical scoring system listed in the Commission Regulation (EC) No. 440/2008, B.4, at approximately 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after exposure (removal of the dressing, gauze patch and test item). 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. An animal is positive when the mean score is 2.3 or greater. The test is positive for irritation when at least 2 animals are positive for the same endpoint (erythema/eschar or edema).

GRADING OF SKIN REACTIONS
Erythema and Eschar Formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) or eschar formation (injuries in depth preventing erythema reading) 4

Edema Formation
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well-defined by definite raising) 2
Moderate edema (edges raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond the area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 7d
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 10d
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 14d
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 7d
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 10d
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 14d
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
IRRITATION
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 edema grades, separately. The individual mean score for erythema/eschar and edema for each of the three animals was 0.

CORROSION
Neither alterations nor corrosive effects were observed on the treated skin.
Other effects:
VIABILITY / MORTALITY
No intercurrent deaths occurred during the course of the study.

CLINICAL SIGNS
No clinical signs were observed throughout the entire observation period.

BODY WEIGHTS
The body weight of the animals was within the range commonly recorded for this strain and age.

SKIN REACTIONS
Slight red staining of the treated skin produced by the test item was noted in all three animals at the 1-hour observation after treatment and persisted up to 7 or 10 days in two females or up to 14 days in the male.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The individual mean score for erythema/eschar and oedema for each of the three animals was 0.
According to the referred classification (Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008), the test material does not have to be classified in respect to the skin irritation study in rabbits.
Executive summary:

The primary skin irritation potential of the test material was investigated according to OECD test guideline No. 404 and Commission Regulation (EC) No. 440/2008, B.4.

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 individual mean score for erythema/eschar and oedema for each of the three animals was 0. The application of the test material to the skin resulted in no signs of irritation. Slight red staining of the treated skin caused by the test item was observed in all animals. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.

According to the referred classification (Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008), the tets material does not have to be classified with respect to skin irritation in rabbits.