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-)

Endpoint summary

Description of key information

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

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

Specific details on test material used for the study:

Identification: FAT 21095/A.
Purity: 80 %

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

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).

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 404 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because skin contact in production and/or use is not likely

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity:

A study was performed to determine the acute oral toxicity of FAT 21095/A, by treating male and female rats at different dose level (3170, 4640, 7750, 10000 mg/kg) and observed over a period of 14 days. The test item was suspend at 30 and 40 % in Carboxymethylcelullose 2 % and administered by oral intubation. 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 had recovered within 7 to 8 days. They were killed 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.

Acute dermal toxicity:

The physicochemical and toxicological properties suggest a low potential for significant rate of absorption through the skin. Furthermore, the results of laboratory animal studies performed to assess skin irritation and skin sensitization potential displayed no acute dermal toxicity. In addition, neither following acute oral application nor following repeated oral application the test substance does exacerbate systemic toxicity effects. Results from the toxicokinetics studies confirmed that upon oral administration the substance is rapidly and completely excreted without potential for bioaccumulation. Taken together, due to the good water solubility oral ingestion and subsequent gastro-intestinal absorption is considered to be the most relevant route of exposure. Since this route does not result in systemic toxicity, dermal exposure is considered to be negligible for systemic toxicity. Therefore, the study will be waived, and the intrinsic property/toxicity potential can be extrapolated from the acute oral route administration.

Acute inhalation toxicity:

The test substance has very low vapour pressure (above the lower detection limits) and a melting point of >180 ºC, therefore the potential for the generation of inhalable vapours is low. Results of laboratory animal studies performed to assess respiratory irritation and respiratory sensitization potential reported no acute inhalation toxicity. In addition, neither following acute oral application nor following repeated oral application the test substance does exacerbate systemic toxicity effects. Results from the toxicokinetics studies confirmed that upon oral administration the substance is rapidly and completely excreted without potential for bioaccumulation. Taken together, due to the good water solubility oral ingestion and subsequent gastro-intestinal absorption is considered to be the most relevant route of exposure. Since this route does not result in systemic toxicity, inhalation exposure is considered to be negligible for systemic toxicity. Therefore, the study will be waived, and the intrinsic property/toxicity potential can be extrapolated from the acute oral route administration.

Justification for classification or non-classification

The acute oral LD50 of FAT 21095/A in rats of both sexes observed over a period of 14 days is 5404 mg/kg. Therefore, FAT 21095/A showed no acute toxicity via oral route of administration.