Tetrasodium 2,2''-diamino-8,8''-dihydroxy-4',4'''-{4-[bis(2-hydroxyethyl)amino]-1,3,5-triazine-2,6-diyldiimino}bis(naphthalene-1-azobenzene-2',6-disulfonate)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 16th to August 5th, 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Red LF 6339

IUPAC Name:

Red LF 6339

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: 12 weeks (male), 12-13 weeks (females)
- Housing: Individually in stainless-steel cages equipped with feed hoppers and drinking water bowls. Wood bloks and haysticks were provided for gnawing.
- Diet (e.g. ad libitum): pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): community tap water from Fullinsdorf ad libitum
- Acclimation: under laboratory conditions after health examination.

ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes: 10-15
- Photoperiod: 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Amount / concentration applied:

- Test item preparation: grounded with a pestle and mortar prior to use.
0.5 g (per animal) of test item was weighed, moistened with approximately 0.1 ml of purified water and applied to the test site. The pH of the test item was measured before the study initiation date. A formulation of 1 % in water was prepared. The pH was found to be 8.96

Duration of treatment / exposure:

4 hours

Observation period:

10 days

Number of animals:

3 per sex

Details on study design:

TEST SITE
- Area of exposure: 100 cm2 intact left flank
- Type of wrap if used: 0.5 g was placed on a surgical gauze patch (ca 4 cm × 4 cm). The dressing was wrapped around the abdomen and anchored with tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was washed with lukewarm water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
- Viability/mortality: daily from delivery of animals to the termination of the test
- Clinical signs: daily from delivery of animals to the termination of the test
- Body weights: at start of acclimatization, on the day of application and at termination of observation

SCORING SYSTEM:
- Method of calculation assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 approximately 1, 24, 48 and 72 hours as well as 7 and 10 days after the removal of the dressing, gauze patch and test item.
To allow further examination of the test site animal number 19 was re-clipped on completion of the 1-hour, 48-hour and 7-day examination. Animal number 20 was similarly re-clipped following the 48-hours and 7-day examination. In evident, corrosice or staining properties of the test item were described and recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 19

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

erythema score

Basis:

animal: 20

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal: 21

Time point:

24/48/72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within: 72 hrs

Results 4

Irritation parameter:

edema score

Basis:

other: all animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

- Irritation: erythema could not be assessed in the male rabbit one hour after removal of the dressing due to a marked violet staining present at the test site. Very slight erythema was however subsequently noted in this animal at the 24- and 72- hour examination. Very slight erythema was similarly observed in one female from 1-48 hours after removal of the dressing
- no clinical signs of systemic toxicity
- no mortality occured
- coloration: a light to marked violet coloured staining was present at the test site of all animals from 1 hour to 7 days after removal of the dressing.
- corrosion: no irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.
- Body weights were considered to be within the normal ange of variabillity

Applicant's summary and conclusion

Interpretation of results:

other: not classified as skin irritant according to the CLP Regulation (EC) No.1272/2008

Conclusions:

not skin irritant

Executive summary:

The primary skin irritation potential of the test material was investigated by topical semiocclusive 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 and 10 days after removal of the dressing.

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