Reaction mass of Disodium [3-{[4-chloro-2-(hydroxy-kO)-5-methoxyphenyl]diazenyl-kN2}-4-(hydroxy-kO)naphthalene-2,7-disulfonato(4-)](hydroxy)chromate(2-) and Trisodium [3-{[4-chloro-2-(hydroxy-kO)-5-methoxyphenyl]diazenyl-kN2}-4-(hydroxy-kO)naphthalene-2,7-disulfonato(4-)](dihydroxy)chromate(3-)

Endpoint summary

Description of key information

The oral median lethal dose (LD50) of test item is 7638 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:

16 August 1974

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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

Species:

rat

Strain:

other: 50 Tif. RAI rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: In-house
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: 160 to 180 g
- Fasting period before study: one night
- Housing: housed in Macrolon cages (Type 3) in groups of 5
- Diet: NAFAG, Gossau SG, rat food) ad libitum
- Water: ad libitum


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

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

polyethylene glycol (PEG 400)

Doses:

3170, 4640, 6000, 7750 and 10000 mg/kg.

No. of animals per sex per dose:

5

Control animals:

no

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)

Sex:

male/female

Dose descriptor:

LD50

Effect level:

7 638 mg/kg bw

Based on:

test mat.

95% CL:

> 6 637 - < 8 790

Mortality:

No mortality was found at 3170 mg/kg dose. One animal each was died at 4640 and 6000 mg/kg dose. 6 animal at 7750 mg/kg and 8 animals at 10000 mg/kg dose.

Clinical signs:

other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 7 to 8 days

Gross pathology:

No substance related gross organ changes were seen.

Interpretation of results:

GHS criteria not met

Conclusions:

The oral median lethal dose (LD50) of FAT 20044/A is 7638 mg/kg.

Executive summary:

An acute oral toxicity study with FAT 20044/A was carried out in rats. The dose level used in the study was 3170, 4640, 6000, 7750 and 10000 mg/kg. 5 rats per sex per dose were administered with test item. There were no mortality was found at 3170 mg/kg dose. However, one animal each was died at 4640 and 6000 mg/kg dose and 6 animal died at 7750 mg/kg and 8 animals at 10000 mg/kg dose. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 7 to 8 days. There were no substance related gross organ changes were seen. So based on the study results, oral median lethal dose (LD50) of FAT 20044/A is 7638 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Quality of whole database:

Comparable to standard acute toxicity study.

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:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute Oral Toxicity:

An acute oral toxicity study with FAT 20044/A was carried out in rats. The dose level used in the study was 3170, 4640, 6000, 7750 and 10000 mg/kg. 5 rats per sex per dose were administered with test item. There were no mortality was found at 3170 mg/kg dose. However, one animal each was died at 4640 and 6000 mg/kg dose, respectively, and 6 animal died at 7750 mg/kg and 8 animals at 10000 mg/kg dose. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 7 to 8 days. There were no substance related gross organ changes were seen. So based on the study results, oral median lethal dose (LD50) of FAT 20044/A is 7638 mg/kg.

 

Acute Inhalation Toxicity:

Currently no study to assess acute inhalation toxicity of Acid Blue 156 is available. However, low vapour pressure owing to high melting point (>350 °C), the substance is considered to have low volatility. Synthesis 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. The chemical showed low toxicity potential in the available acute oral (LD₅₀>7000 mg/kg bw) with no mortality or systemic toxicity, hence it does not need to be classified as STOT SE. Taking into consideration the above arguments, low toxicity potential is expected on acute exposure of Acid Blue 156 via inhalation route.

 

Acute Dermal Toxicity:

Currently no study to assess the acute dermal toxicity of Acid Blue 156 is available. However, this substance found to have high molecular weight 600 g/mol, 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>7000 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 the above arguments into account, low toxicity potential is expected on acute exposure of Acid Blue 156 via dermal route and hence, acute toxicity testing by the dermal route was considered scientifically not necessary.

Justification for classification or non-classification

Based on the observed LD₅₀ of >7000 mg/kg bw in the acute oral toxicity study, the test substance does not considered to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.