tetrasodium 3-amino-4-{[4-({4-fluoro-6-[phenyl(2-{[2-(sulfonatooxy)ethyl]sulfonyl}ethyl)amino]-1,3,5-triazin-2-yl}amino)-2-sulfonatophenyl]diazenyl}-5-hydroxynaphthalene-2,7-disulfonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From Sept. 30, 2004 to Oct. 14, 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

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:

457-630-8

EC Name:

-

Cas Number:

2138836-26-5

Molecular formula:

Hill formula: C29H23FN8Na4O16S5

IUPAC Name:

tetrasodium 3-amino-4-[(1E)-2-[4-({4-fluoro-6-[phenyl({2-[2-(sulfonatooxy)ethanesulfonyl]ethyl})amino]-1,3,5-triazin-2-yl}amino)-2-sulfonatophenyl]diazen-1-yl]-5-hydroxynaphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

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: 254 g (males) and 224 g (females)
- Housing: in transparent macrolon® cages (type III) on soft wood granulate* in an air-conditioned room, 1 animal per cage
- Diet (e.g. ad libitum): ssniff® R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least five days

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

IN-LIFE DATES: From: Sept. 30, 2004, To: Oct 14, 2014

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Remarks:

deionized

Details on dermal exposure:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water in order to remove any unabsorbed remnants of the test substance.
- Time after start of exposure: 24 h

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: 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.
- Necropsy of survivors performed: yes

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 2,000 mg/kg bw. The skin of the animals showed substance related discolorations (reddish). From Day 8 until the end of the study no symptoms were observed.

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 test substance was determined to have the median lethal dermal dose value (LD50) of greater than 2000 mg/kg bw.

Executive summary:

An acute dermal toxicity for the test subsatnce was conducted according to OECD guideline 402, EU method B.3 and EPA OPPTS 870.1200 and in compliance with GLP.

After administration of 2000 mg/kg bw dermally, the animals were observed for 14 d for clinical signs, mortality and body weight change. No clinical signs and mortality occurred. The skin of the animals showed substance related discolorations (reddish) from Day 2 up to Day 7 of the study. Two female animals showed loss of body weight during the first week of the study, which returned to normal until the end of the study. One female animal showed a loss of body weight at the end of the study. In the other animals development of body weight was not impaired. Development of body weight in male animals was not impaired. All animals were sacrificed at the end of the observation period. They showed no macroscopically visible changes.

Under the test conditions, the test substance was determined to have the median lethal dermal dose value (LD50) of greater than 2000 mg/kg bw.