REAKTIVE GELB F 97494

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From October 31, 2001 to November 14, 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

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:

443-090-0

EC Name:

-

Cas Number:

477795-15-6

Molecular formula:

C26H24FN8Na3O14S4

IUPAC Name:

Trisodium 2-{2-[1-ethyl-2-hydroxy-4-methyl-6-oxo-5-(sulfonatomethyl)-1,6-dihydropyridin-3-yl]diazen-1-yl}-4-{[4-fluoro-6-({4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}amino)-1,3,5-triazin-2-yl]amino}benzene-1-sulfonate

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Reaktivgelb F-97494

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 to 10 weeks
- Weight at study initiation: Males: mean=262 g (=100%) (S.D.=±12.6 g); female animals: mean=210 g (=100%) (S.D.=±12.2 g)
- 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 7 d
-Animal identification: cage numbering
Randomization procedure: Computer generated algorithm (archived with raw data) randomization schemes 2001.0529, 2001.0530

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C (except short lasting deviations due to disturbances of air condition)
- Humidity: 50±20 % (except short lasting deviations due to disturbances of air condition)
- Photoperiod: 12 h light/dark cycle

IN-LIFE DATES: From: To: October 31, 2001 to November 14, 2001

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Remarks:

moistened with deionized water to form a paste

Details on dermal exposure:

Before dermal treatment the fur was mechanically removed from the dorsal skin of the animals over an area of approximately 30 cm².

The appropriate amount of the test substance was moistened on a two-ply gauze and an aluminum foil (6 x 8 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.

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:

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 killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No deaths occurred during the whole study.

Clinical signs:

other: No symptoms were observed after administration of test substance. The skin of four animals showed slight erythema from Day 2 to Day 5 of the study. However, the skin of the other animals showed no signs of irritation.

Gross pathology:

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

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the dermal LD50 of the test substance was found to be > 2,000 mg/kg bw in rats.

Executive summary:

A study was conducted to assess the acute dermal toxicity of the test substance in Hsd:Sprague Dawley (SD) rats according to OECD Guideline 423, EU Method B.1. and EPA OPPTS 870.1200, in compliance with GLP.

Groups of five female and five male rats received a single dermal dose of 2,000 mg/kg bw. 500 mg of test substance moistened with 0.4 mL deionized water was applied topically under occlusive conditions for 24 h.

 

No mortality occurred, no clinical signs were observed and no significant macroscopic abnormalities were seen at necropsy. Body weight was also not impaired. Only one female showed a very slight loss of weight between Days 1 and 8. However, the body weight gain returned to normal by end of the study (15 d). Although the skin of four animals showed slight erythema from Days 2 to 5 of the study, no signs of irritation were observed in the rest of the animals.

 

Under the study conditions, the dermal LD50 of the test substance was found to be > 2,000 mg/kg bw in rats.