REAKTIV-GELB F-68 072 FW

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 April 1993 to 21 April 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (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:

lithium sodium 2-amino-4-{[4-(cyanoazanidyl)-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl]amino}-5-(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)benzene-1-sulfonate

EC Number:

413-090-5

Cas Number:

189574-45-6

Molecular formula:

Hill formula: C24H18LixN10NayO12S4

IUPAC Name:

lithium sodium 2-amino-4-{[4-(cyanoazanidyl)-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl]amino}-5-(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)benzene-1-sulfonate

Test material form:

solid: particulate/powder

Details on test material:

See below

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test species: Wistar rat
Strain Hoe: WISKf(SPF71)
Source: HOECHST AG, Kastengrund, SPF breeding colony
Body Weight at start of study: males x = 200 g (= 100 %)
s = ± 5 g
x min = 193 g (- 3.5 %)
x max - 205 g (+ 2,5 %)
n = 5
females x = 193 g (= 100 %)
s = ± 3 g
x min = 188 g (- 2.6 %)
x max = 196 g (+ 1.6 %)
n = 5
Age at start of study: males approx. 7 weeks
females approx. 8 weeks
Randomisation: Randomisation schemes 270/89 and 297/89
Animal maintenance: in fully air-conditioned rooms in Makrolon cages (Type 3) on soft wood granulate one animal per cage
Room temperature: 22 ± 3 ⁰C
Relative humidity: 55 + 20 %
Lighting time: 12 hours daily
Acclimatisation: not necessary (breeding at identical conditions)
Food: Altromin 1324 rat diet (Altromin GmbH, Lage/Lippe), ad libitum
Water: tap water in plastic bottles, ad libitum
Animal identification: cage numbering

Administration / exposure

Type of coverage:

occlusive

Vehicle:

physiological saline

Details on dermal exposure:

Preparation of the test substance
0.5 g Reaktiv-Gelb F-68 072 FW was moistened with 0.25 ml isotonic saline.

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

The appropriate amount of the test substance was moistened on an aluminium foil (6x8 cm) and distributed as uniformly as possible. Together with the foil the test substance was applied 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).

At the end of the dermal exposure period of 24 hours the bandage was removed and the treated skin area washed with warm water in order to remove any unabsarbed remnants of the test substance.

Duration of exposure:

24 h

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Details on study design:

The observation period after the dermal application lasted for 14 days. Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and 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.

Mortality:

No deaths occurred during the whole study.

Clinical signs:

irregular respiration

other: squatting posture, bristling coat, decreased spontaneous activity, hyperactivity, increased respiration rate, stilted and uncoordinated gate

Gross pathology:

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

Other findings:

The skin of all animals was discoloured orange during the whole study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Acute dermal toxicity testing of Reaktiv-Gelb F-68 072 FW in the Wistar rat yielded a median lethal dose above 2000 mg/kg b,w. in both male and female animals.

Executive summary:

The present study was conducted in compliance with OECD Guidelines for Testing of Chemicals, 402 "Acute Dermal Toxicity",andEEC Guideline B.3, Acute Dermal Toxicityin Council Directive 84/449/EEC.This study was conducted in compliance with the Principles of Good Laboratory Practice(GLP).

 

Acute dermal toxicity testing of Reaktiv-Gelb F-68 072 FW in the Wistar rat yielded a median lethal dose above 2000 mg/kg b,w. in both male and female animals.

 

Beside unspecific symptoms the animals showed impairments of respiration and motility as well as diarrhea. Additionally clonic convulsions, trembling, straub tail, straddling hind limbs and hypersensitivity to touch were observed in females. Four days p.a. the animals were free of clinical symptoms.

 

The skin of the animals showed encrustations and coarse scales. Additionally the skin of all animals was discoloured orange during the whole study.

 

Body weight development of the animals was not impaired.

 

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