Reaction products of diazotised 4,4-diaminodiphenylamine-2-sulfonic acid, subsequently coupled with 6-amino-4-hydroxynaphthalene-2-sulfonic acid, further diazotised and coupled with metaphenylendiamine, sodium salts

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

other: experimental result on similar substance

Adequacy of study:

key study

Study period:

September and October 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

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:

Similar substance 03

IUPAC Name:

Similar substance 03

Test animals

Species:

rat

Strain:

other: HanIbm: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Fullinsdorf
- Age at study initiation: 10 weeks males and 12 weeks females
- Weight at study initiation: males: 211-243 g; females: 189-205 g
- Identification: by unique cage number and corresponding colour coded spots on the tail
- Randomization: randomly selected at time of delivery
- Housing: individually in Makrolon type-8 cages with standard softwook bedding ("Lignocel", Schill AG, Muttenz)
- Diet: certificated pelleted standard Kliba 343, Batch 74/90 rat maintenance diet ("Kliba", Klingentalmuehle AG, Kaiseraugust) ad libitum.
- Water: community tap water from Itingen, ad libitum. Bacteriological assay, contaminant and chemical analysis were performed.
- Acclimation period: September 27 to October 3, 1990, one week under laboratory conditions after veterinary examination

ENVIRONMENTAL CONDITIONS
Hourly monitored
- Temperature: 22 ± 3°C
- Humidity: 40-70%
- Air changes: air-conditioned with 10-15 changes per hour
- Photoperiod: 12 hours artificial fluorescent light/12 hours dark, music during the light

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: bi-distilled water

Details on dermal exposure:

TEST SITE
- Area of exposure: approximately 24 hours before treatment, the backs of the animals were clipped with an electric clipper
- % coverage: approximately 10% of the total body surface
- Type of wrap if used: On test day 1, the test article was applied evenly on the skin with a syringe and covered with a semi-occlusive dressing. the dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm tap water
- Dry: with disposable paper towels
- Time after start of exposure: 24 hours

TEST ARTICLE PREPARATION
The test article was placed into a glass breaker on a tered Mattler PE 360 balance and the vehicle (bi-distilled water) was added. A weight/volume dilution was prepared using homogenizer.
Homogeneity of the test article was maintained during treatment using a magnetic stirrer.
The preparation was made immediately prior to dosing.

APPLICATION SUBSTANCE
- Application volume/kg bw: 4 ml at 2000 mg/kg

Duration of exposure:

24 hours; 24 hours after application, the dressing was removed.

Doses:

A single dose of 2000 mg/kg

No. of animals per sex per dose:

5 male and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
Mortality: four times during the test day 1 and daily during days 2-15;
Body Weights: test days 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes performed by experienced prosectors; all animals were necropsied. All animals surviving to the end of the observation period were euthanized by intraperitoneal injection of sodium pentobarbitone
- Other examinations performed:
Clinical signs: Each animal had an examination for changes in appearance and behaviour four times during day 1 and daily during days 2-15. all abnormalities were recorded
General Behaviour
Nose
Respiration
Eye
Motility
Body position
Motor susceptibility
Skin
Various

Statistics:

The LOGIT-Model could not applied to the observed rate of death. The toxicity was estimated without use of a statistical model.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No dead recorded

Clinical signs:

other: The rats exhibited blackened skin throughout the entire study period. No systemic signs were observed in any animals

Other findings:

Macroscopical findings: no findings noted nor in males, nor in females.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The toxicity of test substance was estimated to be greater than 2000 mg/kg

Executive summary:

Test substance was tested for oral acute toxicity according to OECD guideline 402.

A singular dose of 2000 mg/kg was administrated by semiocclusive coverage to rat HanIbm: WIST (SPF).

Result

No dead recorded