Pentasodium 7-(4-(4-(5-amino-4-sulfonato-2-(4-((2-(sulfonato-ethoxy)sulfonyl)phenylazo)phenylamino)-6-chloro-1,3,5-triazin-2-yl)amino-2-ureidophenylazo)naphtalene-1,3,6-trisulfonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 February 1996 to 13 May 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

FAT 40549/A

IUPAC Name:

FAT 40549/A

Test material form:

other: Yellow-brown solid

Details on test material:

- Identification: FAT 40549/A
- Description: Yellow-brown solid
- Batch Number: TV 1
- Stability of Test Article: Stable under storage conditions; expiration date: 01-JAN-2001
- Stability of Test Article in Vehicle: Stable in bi-distilled water for 48 hours.
- Storage Conditions: In the original container, at room temperature (approx. 20 °C), away from direct sunlight.
- Safety Precautions: Routine hygiene procedures were used to ensure the health and safety of the personnel.

Specific details on test material used for the study:

Identification: FAT 40549/A
Description: Yellow brown solid
Batch Number: TV 1
Stability of Test Article: Stable under storage conditions; Expiration date: 01 Jan 2001
Stability of Test Article in Vehicle: Stable in bi-distilled water for 48 hours.
Storage Conditions: In the original container at room temperature (approx. 20°C), away from direct sunlight.
Safety Precautions: Gloves, goggles and face mask were obligatory to ensure the health and safety of the personnel.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, 4414 Füllinsdorf / Switzerland
- Age at study initiation: males: 8 weeks; females: 11 weeks
- Weight at study initiation: males: 223.5 - 245.0 g; females: 191.1 - 210.4 g
- Housing: During acclimatization in groups of five in Makrolon type-4 cages with standard softwood bedding.
- Diet: libitum
- Water: libitum
- Acclimation period: One week under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): relative humidity between 40 - 70% (values above 70% during cleaning process possible)
- Air changes (per hr): Air-conditioned with 10 - 15 air changes per hour
- Photoperiod (hrs dark / hrs light): The animals were provided with a 12-hour light, 12-hour dark cycle, with light between the hours pf 6.00 am and 6.00 pm. Music was played during the daytime light period.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Remarks:

Bi-distilled

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- % coverage: 10 % of the total body surface
- Type of wrap if used: The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water
- Time after start of exposure: Twenty-four hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4.0 mL/kg body weight
- For solids, paste formed: no

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 femals and 5 males per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality / Viability: Four times during test day 1 and once daily during days 2 - 15.
Body Weights: On test days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical signs, Body weight.

Statistics:

The LOGIT-Model could not be used as no deaths occurred.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed

Clinical signs:

other: The clinical signs observed included orange discoloration of the skin in allanimals from test day 2 until termination of the study. Scales were observed in 1 male and 1 female animal from test day 4 to 10 and 4 to 7, respectively.

Gross pathology:

No macroscopic findings were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of acute dermal toxicity test, LD50 (rat, dermal) of the test substance is estimated to be greater than 2000 mg/kg bw.

Executive summary:

The purpose of this study was to assess the acute dermal toxicity of FAT 40'549/A when administered to rats by a single semi-occlusive dermal application, followed by an observation period of 14 days.

The study procedures described in this report are based on OECD Guidelines for Testing of Chemicals, Section 4, Number 402 "Acute Dermal Toxicity", adopted February 24, 1987 and Directive 92/69/EEC, B.3. "Acute Toxicity-Dermal", July 31, 1992.

The test substance was applied to the skin of Wister rats of both sexes for 24 hrs at a dose of 2000 mg/kg bw. No mortality was observed at test concentration. No deviation from normal morphology at necropsy. The body weight gain of the animals was within the normal range for rats of this strain and age.

Therefore, the LD50 of test substance was estimated to be greater than 2000 mg/kg bw, which indicates that test substance is "not classified" in accordance with CLP (Regulaton EC No. 1272/2008) for acute dermal toxicity.