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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08 July 2014 to 01 August 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline 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 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class 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:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Rat, Hsd: Sprague Dawley SD from Harlan Italy s.r.l., san Pietro al Natisone (UD), Italy; females nulliparous and non-pregnant
- Age at study initiation: 7-8 weeks at allocation
- Weight at study initiation: 177. 1-211.0 g at allocation
- Fasting period before study: yes, approximately 17 hours prior to dosing
- Housing: 3 animals/cage
- Diet (e.g. ad libitum): ad libitum, except for the fasting period prior to dosing
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 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): 12/12

IN-LIFE DATES: From: To: 08 July 2014 to 01 August 2014

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg body weight
- Justification for choice of vehicle: solubility of the test item

DOSAGE PREPARATION (if unusual): the test item was suspended in the vehicle at concentration of 200 mg/mL

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on the day of dosing, animals were observed for clinical signs on dosing, approximately 0.5, 2 and 4 hours after dosing; daily thereafter for a total of 14 days. All animals were weighed at allocation to the study (Day -1), on the day of dosing (Day 1) and on Days 2, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic observation during the necropsy procedure

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No clinical signs were observed in the first group of animals initially dosed at 2000 mg/kg (Step 1) and in the further group of 3 females dosed at the same dose level (Step 2).

Gross pathology:

No abnormalities were observed at necropsy examination performed on all animals dosed at 2000 mg/kg at the end of the observation period.

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, did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000 mg/kg. The lack of mortality demonstrates the acute toxicity expected (ATE) to be greater than 2000 mg/kg body weight.

European Directives concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC) No. 1272/2008 and subsequent revisions) would indicate the following:
These results indicate that the test item, Reactive Brown DYHY 0331/0334, did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000 mg/kg. The lack of mortality demonstrates the acute toxicity expected (ATE) to be greater than 2000 mg/kg body weight.

European Directives concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC) No. 1272/2008 and subsequent revisions) would indicate the following:


These results indicate that the test item, Reactive Brown DYHY 0331/0334, did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000 mg/kg. The lack of mortality demonstrates the acute toxicity expected (ATE) to be greater than 2000 mg/kg body weight.
European Directives concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC) No. 1272/2008 and subsequent revisions) would indicate the following:
Classification: Not required
Signal word: None indicated
Hazard statement: None indicated

Executive summary:

The acute toxicity of Reactive Brown DYHY 0331/0334 was investigated following a single oral administration to the Sprague Dawley rat followed by a 14-day observation period.

A first group of 3 female animals was initially dosed at 2000 mg/kg bw (Step 1). No mortality occurred and no clinical signs were observed.

A second group of 3 female animals was then dosed at the same dose level (Step 2). No death occurred and no clinical signs were noted.

Body weight changes recorded during the study were within the expected range for this strain and age of animals.

No abnormalities were observed at necropsy examination performed at the end of the observation period on animals of both groups.

These results indicate that the test item, Reactive Brown DYHY 0331/0334, did not induce toxic effects in the rat following oral administration of a single dose 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 body weight. The LD50 is higher than 2000 mg/kg bw in female rats.