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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 June 1995 to 24 June 1995
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, done to a valid guidelines and the study was conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

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 3-[[4-[[4,6-bis-[(3-sulfonatoprop-1-yl)thio]-1,3,5-triazin-2-yl]amino]-2-methyl-5-methoxy-phenyl]azonaphthalene-1,5-disulfonate
EC Number:
421-950-6
EC Name:
Tetrasodium 3-[[4-[[4,6-bis-[(3-sulfonatoprop-1-yl)thio]-1,3,5-triazin-2-yl]amino]-2-methyl-5-methoxy-phenyl]azonaphthalene-1,5-disulfonate
Cas Number:
187674-70-0
Molecular formula:
C27H26N6Na4O13S6
IUPAC Name:
tetrasodium 3-[[4-[[4,6-bis-[(3-sulfonatoprop-1-yl)thio]-1,3,5-triazin-2-yl]amino]-2-methyl-5-methoxy-phenyl]azonaphthalene-1,5-disulfonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Substance type: yellow-brown to orange powder.
- Storage condition of test material: at room temperature.
- pH: measured at the test facility at a concentration of 10% (w/w) in distilled water was 6.6.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.7 ± 0.1 kg
- Housing: Individually in polystyrene cages (35 x 55 x 32 cm or 48.2 x 58 x 36.5 cm).
- Diet: Pelleted diet ad libitum.
- Water: Filtered water ad libitum
- Acclimation period: At least 5 days.
- Animal selection: The day before treatment, the skin of ach animal was examined in order to use only animals without any signs of cutaneous irritation. Animals showing signs of cutaneous irritation, cutaneous defects or pre-existing dermal injury were not used.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 30 – 70 %
- Photoperiod: 12 hour light/dark cycle.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg per animal as supplied.
Duration of treatment / exposure:
4 hours.
Observation period:
72 hours.
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: 6 cm² on the right flank of each animal. The left flank (clipped) served as an untreated control.
- Type of wrap if used: The test material was prepared on a gauze pad moistened with 0.5 mL of distilled water, and held in place with an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: Any residual test material was removed with gauze moistened with water.
- Time after start of exposure: 4 hours.

SCORING SYSTEM:
Cutaneous examinations were performed at approximately 1, 24, 48 and 72 hours after the removal of the dressing. Dermal irritation was evaluated in accordance with the Draize scale, see Table 1. Any other lesions were noted.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: Mean of observations at 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: Mean of observations at 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: Mean of observations at 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: Mean of observations at 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: Mean of observations at 24, 48 and 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: Mean of observations at 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
Very slight orange colouration of the test site which could not mask an erythema was observed on all animals during the study.
No skin reaction was noted in one animal.
A very slight or slight erythema (grade 1 or 2) was observed one hour after treatment in two of the animals. Erythema persisted for 24 hours in one rabbit only.
No oedema was noted at any time.

Any other information on results incl. tables

Table 2: Individual Dermal Reactions

Rabbit No.

Dermal Irritation

Scores

Mean Irritation Score

1 hr

24 hrs

48 hrs

72 hrs

01

Erythema

1

0

0

0

0.0

Oedema

0

0

0

0

0.0

Other

C

C

C

*

 

02

Erythema

0

0

0

0

0.0

Oedema

0

0

0

0

0.0

Other

C

C

C

*

 

03

Erythema

2

1

0

0

0.3

Oedema

0

0

0

0

0.0

Other

C

C

C

C

 

Mean score calculated from readings taken at 24, 48 and 72 hours.

* = None

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 test, the test material is considered to be a non-irritant since none of the animals displayed a classifiable reaction.
Executive summary:

The acute dermal irritation of the test material was determined in vivo in a study conducted under GLP conditions and in accordance with the standardised guidelines OECD 404 and EU method B.4.

Three male New Zealand White rabbits were exposed to 500 mg of the test material for 4 hours. Dermal irritation was assessed 1 hour after removal and then at 24, 48 and 72 hours after removal according to the Draize scale. Any other lesions were noted.

A very slight orange colouration of the test site which could not mask an erythema was observed on all animals during the study. No skin reaction was noted in one animal. A very slight or slight erythema (grade 1 or 2) was observed one hour after treatment in two of the animals. Erythema persisted for 24 hours in one rabbit only. No oedema was noted at any time.

Under the conditions of the test, the test material is considered to be a non-irritant since none of the animals displayed a reaction severe enough to trigger classification.

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