3,3'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[N-cyclohexyl-2,4,6-trimethylbenzenesulphonamide]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study according to guideline and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

ESTOFIL BLUE S-RLS; batch: C418

IUPAC Name:

ESTOFIL BLUE S-RLS; batch: C418

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf/Switzerland
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: Males: 195 - 219 g; Females: 189 - 203 g
- Fasting period before study: no data
- Housing: Makrolon type-2 cages with standard softwood bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3
- Humidity (%): 40-70%
- Air changes (per hr): > 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsum
- % coverage: 10 % of body surface
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 ml (2000 mg/kg)
- Concentration (if solution): 500 mg/ml
- Constant volume or concentration used: yes
- For solids, paste formed: yes

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation; weekly weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Statistics:

not required

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: Local findings at the site of application: erythema, necroses (males only), scales, blue discoloration (testmaterial is blue pigment)

Gross pathology:

no effects

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a limit test the material did not cause any signs of systemic toxicity. Severe but transient local effects at the site of application were observed.

Executive summary:

The test article was applied to the skin of rats of both sexes for 24 hours at a dose of 2000 mg/kg.

The following death rate was observed: 0 % at 2000 mg/kg

Therefore, the toxicity of the test material was estimated to be: greater than 2000 mg/kg

SYMPTOMS:

The following local findings were observed: 2000 mg/kg: erythema, necroses (males), scales, application area blue discolored (Test material is a blue pigment). The discoloration of the treated skin was observed until termination of observation.