Reaction mass of lithium sodium hydrogen 4-amino-6-({5-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-sulfonatophenyl}diazenyl)-5-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate and lithium sodium hydrogen 4-amino-6-({5-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-sulfonatophenyl}diazenyl)-5-hydroxy-3-{[4-(vinylsulfonyl)phenyl]diazenyl}naphthalene-2,7-disulfonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10.06.86 to 24.06.86

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lithium sodium hydrogen 4-amino-6-(5-(5-chloro-2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate

EC Number:

401-560-2

EC Name:

Lithium sodium hydrogen 4-amino-6-(5-(5-chloro-2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate

Cas Number:

108624-00-6

Molecular formula:

C28H(21-x-y)ClF2Li(x)N8Na(y)O16S5

IUPAC Name:

Lithium sodium hydrogen-4-amino-6-(5-(5-chloro-2,6-difluoropyrimidine-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

Details on test material:

Reactive Blue FC 05717

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: male - 13 wk and female - 15 wk
- Weight at study initiation: male - 280 g and female - 181 g
- Diet (e.g. ad libitum): Altromin 1324 pellet feed
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22°C
- Humidity (%): 40-60%
- Photoperiod (hrs dark / hrs light): 16:8 light-dark cycle

IN-LIFE DATES: From: 10.06.86 To: 24.06.86

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

A homogeneous mixture of the test substance in water was obtained by stirring on a magnetic stirrer. Approx. 24 h before the beginning of the experiment, the fur of the test animals is removed on the back and the shoulders by shaving. In the case of shearing, care is taken that the skin is not injured as this could lead to a change in the permeability. The test substance was then applied on the shaved area and covered with a bandage.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Five

Control animals:

yes

Details on study design:

Following 24 h exposure with the test substance, the bandages were removed and the treated skin areas were rinsed with water. On the day of the application, the animals were examined several times and during the following 14-day observation period the nature, duration and intensity of the clinical symptoms were recorded. Immediately before the application, after a week and at the end of the 14-day observation period, the surviving animals were individually weighed.

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:

There was no mortality.

Clinical signs:

other: No adverse effects were observed.

Gross pathology:

No local gross lesions on the skin were visible.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the dermal LD50 of the test substance to Wistar rats was determined to be >2000 mg/kg bw.

Executive summary:

A study was conducted to determine the acute dermal toxicity of the test substance in Wistar rats according to the EU Method B.3, in compliance with GLP. Male and female Wistar rats were exposed to a single dose of the test substance as a dermal application in this limit test. There were 5 rats per sex, exposed to a nominal concentration of 2000 mg/kg bw. The animals were then observed during 14 d for mortality and clinical signs. Body weights were recorded weekly. Following sacrifice, all surviving rats were dissected and evaluated macroscopically at the end of the study. No mortality, clinical signs and effect on body weight were observed in this study. At test end, no macroscopic lesions were found. Under the study conditions, the dermal LD50 of the test substance was determined to be >2000 mg/kg bw (Ramm, 1986b).