Disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]

Endpoint summary

Description of key information

The acute oral median lethal dose (LD₅₀) of Acid Yellow 079 in rats is greater than 5000 mg/kg bw.

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:

06 June 1975

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:

yes

Specific details on test material used for the study:

Test Compound:
An orange powder, labelled FAT 21015/A.

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals:
Healthy Sprague-Dawley derived rats, bred on the premises, aged 5 weeks, having an average body weight of 148 g males and 115 g females.

Husbandry:
Rats were caged singly and kept in a room maintained at a temperature of 21°C. (+/-2°). Animals were subjected to 12 hours artificial light and 12 hours darkness in each 24 hour period. A commercial pelleted diet (Oakes Special Diet with added Vit. E) was fed ad lib. Water was available at all times.

Ten rats (5M + 5F) Were used for this study.

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Administration of Compound:
A 25 % w/ v solution of the compound in deionised water was administered as a single dose by gavage to rats which had been fasted for 18 hours, at a dose rate of 20ml/kg (equivalent to 5g/kg compound).

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

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, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy was performed.

Statistics:

None

Preliminary study:

None

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the 14 day observation period.

Clinical signs:

other: No clinical symptoms were recorded during the 14 day observation period.

Gross pathology:

At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.

Other findings:

None

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of FAT 21015/A in rats is greater than 5000 mg/kg bw.

Executive summary:

The acute oral toxicity of FAT 21015/A in rats was investigated in a study conducted according to a methodology equivalent to OECD Guideline 401. A single dose of 5000 mg/kg bw was administered to a group of 5 males and 5 females orally. No clinical symptoms were recorded and no deaths occurred during the 14 day observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen. Hence, the acute oral median lethal dose (LD50) of FAT 21015/A in rats was found to be greater than 5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Good quality study conducted following sound and accpeted scientific principles.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

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 the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute toxicity: oral

The acute oral toxicity of FAT 21015/A in rats was investigated in a study conducted according to a methodology equivalent to OECD Guideline 401. A single dose of 5000 mg/kg bw was administered to a group of 5 males and 5 females orally. No clinical symptoms were recorded and no deaths occurred during the 14 day observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen. Hence, the acute oral median lethal dose (LD50) of FAT 21015/A in rats was found to be greater than 5000 mg/kg bw.

Acute toxicity: inhalation

Currently no study to assess the acute inhalation toxicity of Acid Yellow 079 is available. However, the vapour pressure for the substance can be considered low owing to the high melting point (>300 °C). 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 substance is imported into the EU in a formulated form as a dust-free powder or as a granulate, the exposure via inhalation is unlikely. Further, Acid Yellow 079 was found to be miscible in water (water solubility 106 g/L) and have low log partition coefficient (-2.69), 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 (LD₅₀>5000 mg/kg bw), with no mortality or systemic toxicity, hence it does not need to be classified as STOT SE. Taking above arguments into account, low toxicity potential is expected on acute exposure of Acid Yellow 079 via inhalation route and study in this regard is considered to be scientifically not necessary.

Acute toxicity: dermal

Currently no study to assess the acute dermal toxicity of Acid Yellow 079 is available. However, it was found to have high molecular weight 1111.2 g/mol, hence it can be considered to be unfavourable for dermal absorption. Acid Yellow 079 was found to be miscible in water (water solubility 106 g/L), this indicates that partition of the substance from stratum corneum into the epidermis will be low, thereby further limiting the absorption if any dermal exposure occurs. Synthesis of this chemical is performed in a closed process without isolation of reaction products. Isolated products consist of either liquid formulations or dust free granules (non-dusty solid). In addition, the use of this substance will not result in aerosols, particles or droplets, so exposure to humans via the dermal route will be unlikely to occur. The chemical showed low toxicity potential in the available acute oral (LD₅₀>5000 mg/kg bw), with no mortality or systemic toxicity, hence it does not need to be classified as STOT SE.Similarly, absence of local toxicity in eye and skin irritation studies as well as absence of systemic toxicity in sensitization studies, further supports the conclusion that low toxicity is expected for the chemical via the dermal route. Taking above arguments into account, low toxicity potential is expected on acute exposure of Acid Yellow 079 via dermal route and acute toxicity testing by the dermal route was considered scientifically not necessary.

Justification for classification or non-classification

Based on the observed LD₅₀ of >5000 mg/kg bw in the acute oral toxicity study, Acid Yellow 079 does not considered to be classified according to according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.