Alkali salt of sulfonated aryl azo amino sulfonyl aryl azo sulfonyl aryl azo aryl sulfonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 14 July 2014 to 29 July 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guidelne study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

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

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Reactive Brown DYHY 0331/0334

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Italy s.r.l., San Pietro al Natisone (UD), Italy
- Age at study initiation: 8 - 10 weeks (at allocation)
- Weight at study initiation: 275.3 - 285.1 g for males; 225.4 - 261.1 g for females
- Housing: individually caged during the study
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): asd libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C +/-2 °C
- Humidity (%): 55% +/- 15%
- Air changes (per hr): Approximately 15 to 20 air changes per hour
- Photoperiod (hrs dark / hrs light): Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours

IN-LIFE DATES: From: 14 July 2014 (allocation day) To: 29 July 2014 (day of necropsy)

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal surface
- % coverage: 10% of the total body surface
- Type of wrap if used: A patch of surgical gauze covered by a strip of synthetic film was placed over the treated site and the whole assembly held in place by encircling the trunk of the animal with a length of elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): corn oil
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- For solids, paste formed: yes, using 1 mL of sterile water.

Duration of exposure:

24 hours

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for clinical signs on dosing, approximately 1, 2 and 4 hours after dosing on the day of treatment, daily thereafter. All animals were weighed at allocation to the study (Day -1), on the day of dosing (Day 1) and on Days 8 and 15.
- Necropsy of survivors performed: yes, gross necropsy examination for both external and internal abnormalities, with particular attention to the treatment site.

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 occurred.

Clinical signs:

other: No signs of toxicity were observed in male or female animals after treatment during the observation period. Black staining on the dorsal region, due to the colour of the test item, was observed from Day 2 up to Day 14 of the observation period in the majo

Gross pathology:

No abnormalities were found at necropsy examination performed on all animals at termination of the study.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

These results indicate that the test item, Reactive Brown DYHY 0331/0334, has no toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg body weight. The lack of mortality demonstrates the acute toxicity expected (ATE) to be greater than 2000 mg/kg.

Executive summary:

The acute toxicity of Reactive Brown DYHY 0331/0334 was investigated following dermal administration of a single dose to the rat.

A single dose of 2000 mg/kg bw was administered to a group of 5 male and 5 female animals for 24 hours. After 14 days, all animals were killed and subjected to necropsy examination.

No mortality occurred and no signs of toxicological relevance were observed in male or female animals during the observation period.

With the exception of a slight decrease seen in a single female, body weights and body weight changes observed during the study were within the expected range for this species and age of animals.

No abnormalities were found at necropsy in the animals at termination of the study.

These results indicate that the test item, Reactive Brown DYHY 0331/0334, has no toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg bw. The lack of mortality demonstrates the acute toxicity expected (ATE) to be greater than 2000 mg/kg. The dermal LD50 lies above 2000 mg/kg bw for male and female rats.