Tetra(sodium/potassium)-7-[(E)-{2-acetamido-4-[(E)-(4-{[4-chlor-6-({2-[(4-fluor-6-{[4-(vinylsulfonyl)phenyl]amino}-1,3,5-triazin-2-yl)amino]propyl}amino)-1,3,5-triazin-2-yl]amino}-5-sulfonato-1-naphthyl)diazenyl]-5-methoxyphenyl}diazenyl]-1,3,6-naphthalintrisulfonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experiment start date - 28 June 2006; Experiment completion date - 06 July 2006; Study completion date - 24 August 2006.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

not specified

Specific details on test material used for the study:

Identity: FAT 40827/A
Batch: T2 5572 BOP 01/06
Purity: determined in this study
Appearance: black sticky powder
Expiration date: 28.02.2011
Storage: at room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Test System: Young Adult New Zealand White Rabbit (SPF)
Number of animals per test: 3 (Animals of both sexes were used)
Age at treatment: 11-12 weeks (male); 13-14 weeks (females)
Identification: By unique cage number and corresponding ear number.
Acclimatization: Under laboratory conditions after health examination. Only healthy animals were used for the study.
Allocation: Male no. 7 and Female Nos: 8 – 9

Conditions
Standard Laboratory Conditions.
Air-conditioned with ranges for room temperature of 17 - 23 °C and relative humidity 30-70 % and approximately 10-15 air changes per hour. Room temperature and humidity were monitored continuously and values outside of these ranges may have occasionally occurred, usually following room cleaning. These transient variations were considered not to have any influence on the study and, therefore, these data were not reported but were retained at RCC. 12 hours artificial fluorescent light/12 hours dark, music during the light period.
Accommodation: Individually in stainless steel cages with feed hoppers, drinking water bowls. Wood blocks and haysticks 4642 were provided for gnawing.
Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet (batch 24/06) ad libitum.
Water: Community tap water, ad libitum.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

Viability/mortality: Daily from acclimatization of the animals to the termination of test.
Clinical signs: Daily from acclimatization of the animals to the termination of test.
Body weight: At start of acclimatization, on the day of application and at termination of observation.
The skin reaction was assessed at approximately 1, 24, 48 and 72 hours after exposure (removal of the dressing, gauze patch and test item)

Number of animals:

3

Details on study design:

Four days before treatment, the left flank was clipped with an electric clipper, exposing an area of approximately 100 cm² (10cm × 10cm). The skin of the animals was examined one day before treatment, and regrown fur of all animals was clipped again. On the day of treatment, 0.5 g of test item was placed on a surgical gauze patch (ca. 4 cm × 4 cm). This gauze patch was applied to the intact skin of the clipped area. The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape. The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time. The scoring of skin reaction was performed 1, 24, 48 and 72 hours after removal of the dressing.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.

Other effects:

No clinical signs of system toxicity were observed in the animals during the study and no mortality occurred. A slight red staining of the treated skin produced by the test item was observed in all animals 1 hour after removal of the dressing and persisted in one animal still at the 24-hour reading. Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin. The body weights of all rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

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

Executive summary:

The primary skin irritation potential of 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 4 hours. The scoring of skin reaction was performed 1, 24, 48 and 72 hours after removal of the dressing. The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0. A slight red staining of the treated skin produced by the test item was observed in all animals 1 hour after removal of the dressing and persisted in one animal still at the 24-hour reading. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Based on the results of this test, it indicates that the test item shall not be classified in accordance with CLP (Regulation EC No.1272/2008).