Benzenesulfonic acid, 4-amino-, diazotized, coupled with diazotized 4-nitrobenzenamine and resorcinol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

April, 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

study conducted on the analogue substance; the read across justification is detailed in section 13. The Reliability of the Source Study is 2.

Justification for type of information:

The read across justification is detailed in section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

Similar Substance 01

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: authorized vendor
- Weight at study initiation: 175 ± 5 g
- Housing: Makrolon cage (48 x 27 x 20 cm), with bedding of wood chips.
- Diet: free access to an experimental diet for rats, provided by an accredited supplier.
- Water: tap water bottles ad libitum
- Acclimation period: 7 days
- Health check: during acclimatation period

ENVIRONMENTAL CONDITIONS
- Temperature: 21°C (± 2°C).
- Humidity: 55% (± 25%)
- Air changes: 15 air change per hour with filtered air (5 µm)
- Photoperiod: 12 hours cycle dark/light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000 mg for 20 ml of water
- Amount of vehicle : 2 ml of solution for 100 mg of body weight

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 animals per each sex per dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes. the animals were sacrified at the end of the observation period using CO2 or cervical dislocation
- Other examinations performed:
Skin, hair, eyes, mucous membranes, respiratory, circulatory system, central and autonomic nervous system, somatomotor activity and behavior patterns. Particular attention to: tremors, convulsions, salivation, diarrhea, lethargy, sleep and coma.

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:

no clinical signs observed

Body weight:

no body weight lost

Gross pathology:

no significant macroscopic signs observed after necropsy

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to the CLP Regulation (EC) No. 1272/2008

Conclusions:

The LD50 (oral) was found to be be greater than 2000 mg/kg bw.

Executive summary:

The test item was tested for acute toxicity in a limit test, according to the EU Method B.1. Three female and three male Wistar rats were administered 2000 mg/kg bw of the test item, and were subsequently observed for mortality, clinical signs and body weight change for 14 days, after which time all surviving animals were sacrificed and subjected to necropsy.

No mortality, clinical signs or body weight change were observed during the study period including the observation period. No macroscopic signs were observed at necropsy. Therefore, the LD₅₀ (oral) was found to be greater than 2000 mg/kg bw.