Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 June 1998 to 19 June 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, performed in accordance with valid guidelines and the study was conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrasodium 7-[[4-[[4,6-bis[(3-sulfonatopropyl)thio]-1,3,5-triazin-2-yl]amino]-3-methoxyphenyl]azo]naphthalene-1,3-disulfonate
EC Number:
428-480-0
EC Name:
Tetrasodium 7-[[4-[[4,6-bis[(3-sulfonatopropyl)thio]-1,3,5-triazin-2-yl]amino]-3-methoxyphenyl]azo]naphthalene-1,3-disulfonate
Cas Number:
214559-61-2
Molecular formula:
C26H24N6O13S6Na4
IUPAC Name:
tetrasodium 7-{2-[4-({4,6-bis[(3-sulfopropyl)sulfanyl]-1,3,5-triazin-2-yl}amino)-3-methoxyphenyl]diazen-1-yl}naphthalene-1,3-disulfonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Physical state: solid
- Appearance: orange coloured granulous powder
- Storage condition of test material: at room temperature and protected from light

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.3 ± 0.3 kg (mean)
- Housing: individually in polystyrene cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): approximately 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

IN-LIFE DATES: From 16 June 1998 to 19 June 1998

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 hours
Observation period:
3 days post administration
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: On the day prior to application, the flanks of each animal were clipped using electric clippers. A dose of 500 mg of test material was applied to a 6 cm² hydrophilic gauze pad moistened with water and this was then applied to the right flank of the animals for 4 hours. The left flank did not receive any test material and served as an untreated control.
- Type of wrap if used: The test material and gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the dressing was removed and any residual test material was wiped off with a gauze pad moistened with water.
- Time after start of exposure: approximately 4 hours

SCORING SYSTEM:
The Draize scale, presented as table 1 in the field "Any other information on material and methods incl. tables" was used to assess the degree of erythema and oedema at the application sites approximately 1 hour and 1, 2 and 3 days after the removal of the dressings.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no adverse effects observed
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no adverse effects observed
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no adverse effects observed
Irritant / corrosive response data:
A well-defined erythema (grade 2) was observed in two animals on days 1 and 2, then a very slight erythema (grade 1) was noted in these animals on day 3. In the third animal, only a very slight erythema (grade 1) was observed on days 1 and 2.
A slight orange colouration of the skin was noted in all animals from day 1 up to the end of the observation period (day 4).

Any other information on results incl. tables

Table 2: Individual cutaneous examination and mean values of the scores recorded at each time point for each animal

Animal no.

Dermal irritation

Scores

Mean irritation score*

1 h

24 h

48 h

72 h

1

Erythema

2

2

1

0

1.0

Oedema

0

0

0

0

0.0

Other

C

C

C

C

2

Erythema

2

2

1

0

1.0

Oedema

0

0

0

0

0.0

Other

C

C

C

C

3

Erythema

1

1

0

0

0.3

Oedema

0

0

0

0

0.0

Other

C

C

C

C

* of the 24, 48 amd 72 hour scores

C = orange colouration of the skin

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, the test material did not elicit any reaction in any of the animals during the course of the study that meant the test material required classification as a skin irritant. Only very slight erythema was seen and this was fully reversible with 72 hours. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
Executive summary:

The skin irritation potential of the test material was determined in accordance with standardised guidelines OECD 404 and EU Method B.4. Three rabbits received a single four hour application of 500 mg of test material and were assessed for the following 3 days for any signs of skin irritation. The mean score over 24, 48 and 72 hours for each individual animal was 0.0 for oedema. The mean score over 24, 48 and 72 hours for each individual animal was 1.0, 1.0 and 0.3 for erythema. All skin reactions were fully reversible within 72 hours. Therefore, under the conditions of the study, the test material did not elicit any reaction in any of the animals during the course of the study that meant the test material required classification as a skin irritant.