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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD TG 402 and EEC Directive 440/2008 Part B, Method B.3

GLP compliance:

yes

Test type:

standard acute method

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:

Dye content: 41.2 %

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 9-13 weeks
- Weight at study initiation: males: 269-276g; females: 233-256 g
- Fasting period before study:
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The undiluted test item was used for treatment, considering the content of 41.2%.
2000 mg/kg bw (solid content) was applied onto the shorn back of 5 male and 5 female rats and held in place by semi-occlusive dressing The treatment time was 24 hours. After removing of the dressing the treated area was rinsed. The animals were observed for clinical signs and mortality over a period of 14 days.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw (solid content)

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not required

Details on study design:

2000 mg/kg bw was applied onto the shorn back of 5 male and 5 female rats and held in place by semi-occlusive dressing The treatment time was 24 hours. After removing of the dressing the treated area was rinsed. The animals were observed for clinical signs and mortality over a period of 14 days.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no animal died, none showed any reaction on treatment

Mortality:

No animal died

Clinical signs:

other: No clinical signs were observed

Gross pathology:

No grosspathological findings

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Bayscript Blaukomponente (konserviert) was applied dermally to the shorn back and flank of groups of male and female Wistat rats at a dose of 2000 mg/kg bw (considering solid content) under semi-occlusive conditions (OECD TG 402). After approximately 24 hours the dressings were removed and the area was rinsed with tepid water using soap and gently patting the area dry. The dose of 2000 mg/kg bw was tolerated by male and female rats without mortalities or toxcolological relevant clinical signs. No adverse effects on body weight development in males and females nor gross pathological findings were observed. Thus, the LD50 (rat, dermal) for the solid content is > 2000 mg/kg bw. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.

Executive summary:

Bayscript Blaukomponente (konserviert) was applied dermally to the shorn back and flank of groups of male and female Wistat rats at a dose of 2000 mg/kg bw under semi-occlusive conditions (OECD TG 402). After approximately 24 hours the dressings were removed and the area was rinsed with tepid water using soap and gently patting the area dry. The dose of 2000 mg/kg bw (considering solid content) was tolerated by male and female rats without mortalities or toxcolological relevant clinical signs. No adverse effects on body weight development in males and females nor gross pathological findings were observed. Thus, the LD50 (rat, dermal) for the solid content is > 2000 mg/kg bw. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.