Trisodium 7-[[4-chloro-6-[ethyl[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methoxy-2-sulphonatophenyl)azo]naphthalene-2-sulphonate

Acute Toxicity: dermal

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Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

red 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, Gartenstr. 27, 33178 Borchen
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 6 - 10 weeks
- Weight at study initiation: males: 280 ± 19.2 g; females: 201 ± 6.3 g
- Fasting period before study: NA
- Housing: single
- 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 seven days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: January 20, 1999 to February 03, 1999

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Remarks:

0.45 ml deionized water to moisten test substance

Details on dermal exposure:

TEST SITE
- Area of exposure: 30 cm²
- % coverage:
- Type of wrap if used: The treated skin area was covered with a two-ply gauze and an aluminium foil (6 x 8 cm), which 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)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g pasted with 0.45 ml deionized water
- Concentration (if solution): -
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.45 mL
- Concentration (if solution): -
- Lot/batch no. (if required): -
- Purity:-

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Five per sex per group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: obsetvation twice daily; weighing 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.

Mortality:

no

Clinical signs:

none

Body weight:

no effects

Gross pathology:

no effects

Other findings:

The skin of the animals was discolored orange in a large area.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the acute dermal LD50 of the substance in rats was determined to be greater than 2000 mg/kg bw.

Executive summary:

A study was conducted to determine the acute dermal toxicity of the test substance according to OECD Guideline 402, in compliance with GLP. The acute dermal toxicity of was tested in groups of 5 Sprague-Dawley rats/sex at a limit dose level of 2000 mg/kg bw only. No deaths or clinical signs were observed during the entire study period. The skin of the animals was discoloured orange in a large area; development of body weight was not impaired. The animals killed at the end of the observation period showed no macroscopically visible changes. Under the study conditions, the acute dermal LD50 of the substance in rats was determined to be greater than 2000 mg/kg bw (Seeberger, 1999).