1,3-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, diazotized, coupled with diazotized 2-amino-4,6-dinitrophenol, diazotized 4-amino-5-hydroxy-2,7-naphthalenedisulfonic acid, diazotized 4-amino-3-methylbenzenesulfonic acid, diazotized 4-nitrobenzenamine and resorcinol, sodium salts

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From November 23 to December 14, 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study conducted according to internationally accepted testing guideline and following the GLP Principles.

Justification for type of information:

Justification for Read Across is detailed in the endpoint summary and it is further detailed in the report attached to the IUCLID section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

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))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

Similar substance 01 of Acid Brown 147

IUPAC Name:

Similar substance 01 of Acid Brown 147

Test material form:

solid: particulate/powder

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: (♂) 11 weeks, (♀) 13 weeksWeight at study initiation: (♂) 256 - 282 g; (♀) 199 - 213 g
Housing: individually in Makrolon type-2 cages with standard softwood bedding
Diet (ad libitum): Ad libitum Pelleted standard Kliba 343, Batch 31/88 rat maintenance diet
Water: ad libitum community tap water from Itingen
Acclimation period: at least one week under laboratory conditions after veterinary examinations
ENVIRONMENTAL CONDITIONS
Temperature: 22 ± 3 °CHumidity (%): 40 - 70 %Air changes (per hr): 10 - 15
Photoperiod (hrs dark / hrs light): 12/12 (during the light period: music)

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
Area of coverage: 10% of the total body surfaceType of wrap if used: occlusive dressing, wrapped around the abdomen and fixed with an elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
Washing: the treated skin was washed with lukewarm tap water, dried with disposable towels.
Time after start of exposure: 24 hours
TEST MATERIALAmount(s) applied (volume or weight with unit): 4 ml at concentration of 2000 mg/kg bw

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

Duration of observation period following administration: 15 days
Frequency of observations and weighing:
Mortality/viability: Four times during test day 1 and daily during days 2 - 15
Body weights: Test day 1 (pre-administration), 8 and 15
Symptoms: each animal had an examination for changes in appearance and behaviour four times during day 1, and daily during days 2 - 15
Necropsy of survivors performed: yes

Statistics:

The LOGIT-model could not be 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:

not specified

Mortality:

No death occurred

Clinical signs:

At the dose of 2000 mg/kg bw the following signs were observed: Erythema, Brown discolored application area
Scales (females)

Body weight:

No variations from the normal bodyweight increase have been observed

Gross pathology:

No macroscopic organ changes have been observed

Applicant's summary and conclusion

Interpretation of results:

other:

Remarks:

Not classified according to the CLP Regulation

Conclusions:

LD50 > 2000 mg/kg bw

Executive summary:

Method

The test has been conducted according to the OECD Guideline 402 and to the EU Method B.3.

A limit test has been conducted on 5 male and 5 female rats using the single dose of 2000 mg/kg bw.

Observations

During the test no death occurred, no variations in the normal increase of the body weight and no macroscopic organ changes have been observed.

Result

The LD50 of the test item is greater than 2000 mg/kg bw.