Disodium [2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)

Endpoint summary

Description of key information

The acute oral LD50 of FAT 20013 was found to be greater than 5000 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:

Study completion date: 08 April 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

Name: FAT 20013/A
Purity: 59%

Species:

rat

Strain:

other: CFY strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

Weight: 99 to 118g

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

FAT 20013/A was prepared as a 30% suspension in water and administered at a maximum dosage volume of 16.7ml/kg bodyweight. Rats treated with water alone (16.7ml/kg) served as controls.

Doses:

0 and 5000 mg/kg

No. of animals per sex per dose:

5 animals per sex

Control animals:

yes

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 95% CL not specified

Mortality:

No mortality observed.

Clinical signs:

other: Signs of reaction to treatment, observed within a few hours of dosing included piloerection, lethargy, moderate diarrhoea and diuresis. The urine of all. animals was observed to be blue-black in colour. A slight increase in respiratory rate was observed s

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of compound FAT 20013/A in rats is greater than 5000 mg/kg bw.

Executive summary:

The acute oral toxicity of FAT 20013/A was evaluated in a limit test using rats according to method similar to OECD test guideline 401.

5 males and 5 females were administered a single dose of 5000 mg/kg bw orally. After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, animals were killed by exsanguination under ether anesthesia and an autopsy performed.

No deaths occurred. Signs of reaction to treatment, observed within a few hours of dosing included piloerection, lethargy, moderate diarrhea and diuresis. The urine of all animals was observed to be blue-black in colour. At autopsy, no changes caused by the administration of FAT 20013/A were seen.

In conclusion, the acute oral LD50 of FAT 20013/A in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute toxicity: oral

The acute oral toxicity of FAT 20013/A was evaluated in a limit test using rats according to method similar to OECD test guideline 401. 5 males and 5 females were administered a single dose of 5000 mg/kg bw orally. After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, animals were killed by exsanguination under ether anesthesia and an autopsy performed. No deaths occurred. Signs of reaction to treatment, observed within a few hours of dosing included piloerection, lethargy, moderate diarrhea and diuresis. The urine of all animals was observed to be blue-black in colour. At autopsy, no changes caused by the administration of FAT 20013/A were seen.

In conclusion, the acute oral LD50 of FAT 20013/A in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg bw.

Acute inhalation toxicity:

Currently no study to assess the acute inhalation toxicity potential of Acid Black 207 is available. The melting point of test substance was found to greater than 300°C indicating lowvapour pressure. Hence, the substance is considered to have low volatility. Synthesis and spray drying of this chemical is performed in a closed process; the final product consists of non-dusty granules. Hence, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Based on column 2, ‘Specific rules for adaptation from column 1’ of the table given in REACH Annex VII, the study on acute inhalation toxicity only needs to be conducted if an exposure via inhalation is to be expected, based on vapour pressure and/or the likelihood of an exposure to aerosols, particles or droplets. Referring to the expected low volatility of the substance, the fact that the chemical is imported into the EU in a formulated form as a dust-free powder or as a granulate, the exposure via inhalation is considered to be unlikely. Further, the chemical is found to have water solubility of 6.9 g/L, hence, in the case of dust of the substance entering the respiratory tract, it will be trapped in the mucus and cleared, thereby further limiting the absorption. The chemical showed low toxicity potential in the available acute oral toxicity study (LD50: > 5000 mg/kg bw), with no systemic toxicity being seen, hence it does not need to be classified STOT SE and low toxicity is expected for this chemical via the inhalation route. Taking into consideration the above arguments, low toxicity potential is expected on acute exposure via inhalation route and hence testing by the inhalation route was considered scientifically not necessary.

Acute dermal toxicity:

Currently no study to assess the acute dermal toxicity potential of Acid Black 207 is available. However, the molecular weight of Acid Black 207 is 821.6 g/mol, indicating it being too large for dermal absorption. It has water solubility of 6.9 g/L and n-octanol/water partition coefficient (log P) of 1.57, indicating it being hydrophilic to cross the lipid rich environment of the stratum corneum. Hence, the dermal uptake for the substance will be low. The chemical showed low toxicity potential in the available acute oral toxicity study (LD50: >5000 mg/kg bw), with no systemic toxicity observed, hence, it does not need to be classified as STOT SE. Similarly, absence of systemic toxicity in skin irritation and sensitisation studies, further supports the conclusion that no adverse effects are expected for the chemical via the dermal route. Further, experience with similar chemical substances has demonstrated that it is very unlikely that toxicity related to the intrinsic properties of the chemical only show up upon dermal exposure and not after systemic application. Taking above arguments into consideration, low toxicity is expected on acute dermal exposure of Acid Black 207 and testing by the dermal route was considered scientifically not necessary.

Justification for classification or non-classification

Based on the available data from acute toxicity study with FAT 20013, the test substance does not meet the criteria for classification for acute toxicity according to the CLP (1272/2008) Regulation.