Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts

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:

other: Guideline study and GLP

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:

Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts

EC Number:

291-454-0

EC Name:

Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts

Cas Number:

90411-76-0

Molecular formula:

Mixture of components, no definitve molecular formula existing.

IUPAC Name:

Complex mixture of phenazine dyes - IUPAC name not available

Test material form:

other: solid

Details on test material:

black solid
content: 80.7%

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 291-300 g
females 226-247 g
- 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 test substance was applied to a wet gauze layer which was then applied to the shaved area of the back of the rabbits. The patches were held in place by semi-occlusive dressing (gauze strip and a tape). After 24 hours the dressings were removed and the area was rinsed with tepid water

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

other: the opposite site of the back of each animal served as control

Details on study design:

The test substance was applied to a wet gauze layer which was then applied to the shaved area of the back of the rabbits. The patches were held in place by semi-occlusive dressing (gauze strip and a tape). After 24 hours the dressings were removed and the area was rinsed with tepid water. The opposite site of the back of each animal served as control. Animals were observed for clinical signs and mortality for 14 days, weight gain was checked weekly. after termination of the observation period the animals were sacrificed and examind macroscopically

Statistics:

Only the limit dose was tested

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

2 000 mg/kg bw

Remarks on result:

other: no death occurred and no clinical signs were reported

Mortality:

no animal died

Clinical signs:

other: no clinical sign is reported

Gross pathology:

no gross pathological f9nding

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Executive summary:

Nigrosin WLF 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 semiocclusive conditions. 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) is > 2000 mg/kg bw.