sodium hydrogen [5-(diethylamino)-2-[(2-hydroxy-4-nitrophenyl)azo]phenolato(2-)][5-hydroxy-6-[(2-hydroxy-4-nitrophenyl)azo]-1-naphthalenesulfonato(3-)]-, chromate(2-)

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:

From April 19 to May 3, 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

In two males the allowed initial body weight was exceeded by 2 and 3 g, respectively.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 02

IUPAC Name:

Similar Substance 02

Test animals

Species:

rat

Strain:

other: Tif : RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production 4332 Stein/Switzerland
- Weight at study initiation: 182 to 243 g
- Fasting period before study: Prior to dosing, the animals were fasted overnight.
- Housing: The animals were housed in Macrolon cages type 4, with standardized soft wood bedding (Société Parisienne des Sciures, Pantin, France).
- Diet: Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland) ad libitum.
- Water: ad libitum.
- Acclimation period: at least for 5 days before administration.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hour/day light cycle.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Details on oral exposure:

VEHICLE
- Volume applied: 10 ml/kg body weight

Doses:

2000 mg/kg (males and females)

No. of animals per sex per dose:

5 per sex per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: - Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days: - Signs and symptoms: daily for 14 days; - Body weight: immediately before administration and on days 7 and 14.
- Necropsy of survivors performed: yes, The animals were submitted to a gross necropsy at the end of the observation period.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities occurred in this study

Clinical signs:

other: pilerection, hunched posture and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 3 days.

Any other information on results incl. tables

Necropsies:

At necropsy, no deviations from normal morphology were found in all animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 > 2000 mg/kg bw

Executive summary:

Method:

The test substance was tested for its Acute Oral Toxicity according to OECD guideline 401 and EU Method B.l.

 

Observations:

Piloerection, hunched posture and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 3 days. At necropsy, no deviations from normal morphology were found in all animals.

 

Results:

LD₅₀ > 2000 mg/kg bw