Disodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxybenzenesulphonato(3-)][1-[[2-hydroxy-5-(phenylazo)phenyl]azo]-2-naphtholato(2-)]chromate(2-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Pre-guideline study comparable to OECD 401

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxybenzenesulphonato(3-)][1-[[2-hydroxy-5-(phenylazo)phenyl]azo]-2-naphtholato(2-)]chromate(2-)

EC Number:

258-027-0

EC Name:

Disodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxybenzenesulphonato(3-)][1-[[2-hydroxy-5-(phenylazo)phenyl]azo]-2-naphtholato(2-)]chromate(2-)

Cas Number:

52587-68-5

Molecular formula:

C38H25CrN8O7S.2Na

IUPAC Name:

Disodium [4-(hydroxy-kO)-3-{[5-(hydroxy-kO)-3-methyl-1-phenyl-1H-pyrazol-4-yl]diazenyl-kN1}benzenesulfonato(3-)][1-({2-(hydroxy-kO)-5-[phenyldiazenyl]phenyl}diazenyl-kN1)naphthalen-2-olato(2-)-kO]chromate(2-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Specific details on test material used for the study:

Identification: FAT 21095/A.
Purity: 80 %

Test animals

Species:

rat

Strain:

other: Tif. RAI

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 6 to 7 weeks old
- Weight at study initiation: 160 to 180 g.
- Fasting period before study: The rats were starved during one night before starting the treatment.
- Housing:The males and females were segregated and housed in Macrolon cages (Type 3) in groups of 5 in a room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 50

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

FAT 21095/A was suspended at 30 % and 40 % with carboxymethylcellulose 2 %.
VEHICLE
- Concentration in vehicle: 30 and 40 %
- Amount of vehicle (if gavage):carboxymethylcellulose: 2 %

Doses:

3170, 4640, 7750 and 10000 mg/kg

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology.

Statistics:

The LD50 was calculated by probit analysis method (Goulden A., Methods of Statistical Analysis, John Wiley and Sons, 1960, 3rd printing, pages 404-408).

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 404 mg/kg bw

Based on:

test mat.

Mortality:

At 4640 mg/kg: 2 males and 2 females died at the end of day 14.
At 7750 mg/kg: 3 males and 5 females died at the end of day 14.
At 10000 mg/kg: All rats died within 24hrs.

Clinical signs:

other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position, diarrhoea and ruffled fur. Sedation, diarrhoea and ruffled fur became more accentuated as the dose was increased. The surviving animals

Gross pathology:

No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of FAT 21095/A in rats of both sexes observed over a period of 14 days is 5404 (4460-6547) mg/kg.

Executive summary:

The acute oral toxicity of FAT 21095/A was determined using male and female rats. 5 males and 5 females were treated at different dose level (3170, 4640, 7750, 10000 mg/kg). The test item was suspend at 30 and 40 % in Carboxymethylcelullose 2 % and administered by oral intubation and observed over a period of 14 days. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position, diarrhoea and ruffled fur. Sedation, diarrhoea and ruffled fur became more accentuated as the dose was increased. At 4640 mg/kg: 2 males and 2 females died at the end of day 14. At 7750 mg/kg: 3 males and 5 females died at the end of day 14. At 10000 mg/kg: All rats died within 24hours. The surviving animals had recovered within 7 to 8 days. They were sacrified and autopsied after an observation period of 14 days. No substance related gross organ changes were seen. The LD50 was calculated by probit analysis method. The acute oral LD50 of FAT 21095/A in rats of both sexes observed over a period of 14 days is 5404 (4460-6547) mg/kg. The compound has therefore no acute toxicity to the rat by this route of administration.