2-Naphthalenesulfonic acid, 4-hydroxy-3-[2-[2-methoxy-5-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-7-[(sulfomethyl)amino]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:5)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From Mar. 30, 2005 to Apr. 13, 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

464-700-1

EC Name:

-

Cas Number:

607724-42-5

Molecular formula:

Hill formula: C28H24N5Na5O23S7 CAS formula: C28H29N5O23S7.5Na

IUPAC Name:

pentasodium 4-hydroxy-3-(2-{2-methoxy-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-8-(2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-7-[(sulfonatomethyl)amino]naphthalene-2-sulfonate

Test material form:

solid: particulate/powder

Details on test material:

Reactive Red F01-0481

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstrasse 27, D-33178, Borchen.
- Age at study initiation: 6-10 weeks
- Weight at study initiation: 248.8±15.4 g (males); 215.2±5.6 g (females)
- Housing: in transparent macrolon® cages (type III) on soft wood granulate* in an air-conditioned room, 1 animal per cage
- Diet: ssniff® R/M-H (V 1534), ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: At least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C
- Humidity: 50±20 %
- Photoperiod: 12 h light/dark cycle

IN-LIFE DATES: From Mar. 30, 2005 to Apr. 13, 2005

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: 30cm2
- Type of wrap if used: Fixomull and Elastoplast

REMOVAL OF TEST SUBSTANCE
- Washing: With warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: 0.5 g
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied: 0.3 mL

Duration of exposure:

24 h

Doses:

2,000 mg/kg bw

No. of animals per sex per dose:

5/sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Twice every day (in the morning and in the afternoon), on weekends and public holidays only once.
- Necropsy of survivors performed: yes
- Other examinations performed: Mortality, body weight, clinical observations and macroscopical examinations

- Overall study design: Before dermal treatment the fur was mechanically removed from the dorsal skin of the animals over an area of approximately 30 cm². 0.5 g test substance was moistened with 0.3 mL deionized water on a two-ply gauze and an aluminum foil (6x8 cm) and distributed as uniformly as possible. Together with the foil the test substance was administered to the shaved and intact dorsal skin. The foil was held in place with an elastic plaster bandage fixed around the animal's body (Fixomull and Elastoplast, 8 cm in width, both manufactured by Beiersdorf Aktiengesellschaft).
At the end of the dermal exposure period of 24 h the bandage was removed and the treated skin area washed with warm water in order to remove any unabsorbed remnants of the test substance.
The observation period after the dermal administration lasted for 14 d. Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During this time the animals were weighed weekly. At the end of the observation period the animals were sacrificed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the whole study

Clinical signs:

other: No test substance related symptoms were observed after administration of 2,000 mg/kg bw. The skin of the animals showed substance related discolorations (by compound) starting on Day 2 in all animals and lasting up to Day 13 of the study on some animals.

Gross pathology:

The animals killed at the end of the observation period showed no macroscopically visible changes.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the dermal LD50 value for the test substance was found to be >2000 mg/kg bw.

Executive summary:

A study was conducted to assess the acute toxicity of the test substance on rats according to EU Method B.3 and OECD Guideline 402, in compliance with GLP.

The animals (5/sex) were exposed to the test substance at the dose rate of 2,000 mg/kg bw for the period of 24 h. At the end of the dermal exposure period, the bandage was removed and the treated skin area washed with warm water in order to remove any unabsorbed remnants of the test substance. The observation period after the dermal administration lasted for 14 d. Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During this time the animals were weighed weekly. At the end of the observation period the animals were sacrificed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.

No deaths occurred during the whole study. One female animal showed a slight loss of body weight at the end of the study. In the other female and male animals development of body weight was not impaired. No test substance related symptoms were observed after administration of 2,000 mg/kg bw. The skin of the animals showed substance related discolorations (by compound) starting on Day 2 in all animals and lasting up to Day 13 of the study on some animals.

Hence, under the test conditions, the dermal LD50 value for the test substance was found to be >2,000 mg/kg bw.