Reaction mass of lithium sodium 5-amino-3-{[4-(2-{4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)diazenyl]-2-sulfophenyl}vinyl)-3-sulfophenyl]diazenyl}-4-hydroxynaphthalene-2,7-disulfonate 2,2'-(methylimino)diethanol (1:1) and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[6-amino-4-hydroxynaphthalene-2-sulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of lithium sodium 5-amino-3-{[4-(2-{4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)diazenyl]-2-sulfophenyl}vinyl)-3-sulfophenyl]diazenyl}-4-hydroxynaphthalene-2,7-disulfonate 2,2'-(methylimino)diethanol (1:1) and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[6-amino-4-hydroxynaphthalene-2-sulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol

EC Number:

916-916-7

Molecular formula:

not available

IUPAC Name:

Reaction mass of lithium sodium 5-amino-3-{[4-(2-{4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)diazenyl]-2-sulfophenyl}vinyl)-3-sulfophenyl]diazenyl}-4-hydroxynaphthalene-2,7-disulfonate 2,2'-(methylimino)diethanol (1:1) and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[6-amino-4-hydroxynaphthalene-2-sulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol

Test material form:

other: liquid

Details on test material:

not given in the report

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3.2-3.3 kg
- Housing: individually
- Diet ad libitum:
- Water ad libitum
- Acclimation period: at least 14 dqys

ENVIRONMENTAL CONDITIONS
- Temperature (°C):20
- Humidity (%):50
- Air changes (per hr):10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: the opposite side of the back served as control

Amount / concentration applied:

500 µl

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Details on study design:

500 µl was applied to the shaved back of each of 3 rabbits and covered by semi-occlusive dressing. The exposure time was 4 hours. The opposite side of the back served as control. After removing of the dressing the treated area was carefully washed. The observation period lasted 14 days. The area were evaluated according to prescription of the guideline.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 hour - 14 days

Score:

ca. 0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1h - 14 d

Score:

ca. 0

Max. score:

4

Irritant / corrosive response data:

the above results show that the test compound can be regarded as not irritating to the skin

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Skin irritation test was performed according to OECDTG 404 and GLP: 500 µl was applied to the shaved back of each of 3 rabbits and covered by semi-occlusive dressing. The exposure time was 4 hours.The opposite side of the back served as control. After removing of the dressing the treated area was carefully washed. The observation period lasted 14 days. The area were evaluated according to prescription of the guideline. No erythema(score0 of mac 4) or edema (score 0 of max 4) were observed in none of the 3 rabbits. Therefore, the test compound can be evaluated as not irritating to the skin. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.

Executive summary:

Skin irritation test was performed according to OECDTG 404 and GLP: 500 µl was applied to the shaved back of each of 3 rabbits and covered by semi-occlusive dressing. The exposure time was 4 hours.The opposite side of the back served as control. After removing of the dressing the treated area was carefully washed. The observation period lasted 14 days. The area were evaluated according to prescription of the guideline. No erythema(score0 of mac 4) or edema (score 0 of max 4) were observed in none of the 3 rabbits. Therefore, the test compound can be evaluated as not irritating to the skin. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.