Disodium [N-(2-chlorophenyl)-2-[(2-hydroxy-5-nitrophenyl)azo]-3-oxobutyramidato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: data sharing dispute

Adequacy of study:

key study

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Disodium [N-(2-chlorophenyl)-2-[(2-hydroxy-5-nitrophenyl)azo]-3-oxobutyramidato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

EC Number:

276-649-0

EC Name:

Disodium [N-(2-chlorophenyl)-2-[(2-hydroxy-5-nitrophenyl)azo]-3-oxobutyramidato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

Cas Number:

72403-66-8

Molecular formula:

C36H21ClCrN7Na2O12S

IUPAC Name:

disodium [N-(2-chlorophenyl)-2-[(2-hydroxy-5-nitrophenyl)azo]-3-oxobutyramidato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

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 LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 175-210 g
- Fasting period before study: overnight
- Housing: caged in group of 5 in Macrolon cages type 4 (Société Parisienne des sciures, Pantin)
- Diet (e.g. ad libitum): ad libitum, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland)
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 55 ± 15%
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80

Doses:

5000 mg/kg body weight

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days or until symptoms have disappeared
- Frequency of observations and weighing: daily for mortality and sign or symptoms; on days 1, 7, 14
and at death for body weight
- Necropsy of survivors performed: yes

Statistics:

From the body weights, the group means and their standard deviations were calculated.
Where feasable, the LD50 including the 95% confidence limit were computed by the logit method (J.
Berkson, J.Am. Stat. Ass. 39. 357-65, 1944)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No dead rats observed.

Clinical signs:

other: Dyspnoea, exophthalmus, ruffled fur and curved body position were seen. In addition, a transient dia rrhoea was observed. The surviving animals recovered within 11 days.

Gross pathology:

No gross lesions were found at necropsy.

Any other information on results incl. tables

Signs and symptoms

Observations

Exposure day: hours

Days of post-exposure period

1

2

3

5

1

2

3

4

5

6

7

8

9

10

11

12

13

>13

5000 mg/kg

dyspnoea

xx

xx

xx

xx

x

x

x

x

x

x

x

x

x

x

exophthalmus

x

x

x

x

x

x

x

x

x

x

x

x

x

ruffled hair

x

x

x

x

x

x

x

x

x

x

x

x

diarrhoea

x

x

x

body position curved

x

x

x

x

x

x

x

x

x

x

 

 

 

 

 

 

 

 

 

 

 

 

 

 

x=slight              xx=moderate                   xxx=marked

 

Body weights and standard deviations

	males			females
dose mg/kg	day 1	day 7	day 14	day 1	day 7	day 14
5000	203 / 5.1	275 / 10.9	315 / 13.4	182 / 8.0	218 / 11.3	231 / 11.5

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 > 5000 mg/kg body weight.

Executive summary:

Method
The test substance was tested for acute toxicity for oral route on rats following the OECD guideline 401.
The strain chosen for the test was: Rat, Tif:RAIf, F3-crosses of RII 1/Tif x RII 2/Tif. They were caged in
groups of 5 in Macrolon cages type 4 with food and water freely available.
Prior to dosing, the animals were fasted overnight. The animals were allocated to the different dose
groups by random selection.
The test substance was administered orally by gastric intubation (gavage) at a dose level of 5000
mg/kg bw on 5 males and 5 females. The observation period was 14 days or until all symptoms have
disappeared.
Spontaneously dying animals were submitted to a gross necropsy; survivors at the end of the
observation period.
No deaths were observed during the exposure and the post exposure period and no gross lesions were
found at necropsy.
Results
The LD50 observed was higher than 5000 mg/kg bw.