Sodium bis[N-(2-chlorophenyl)-2-[[2-hydroxy-5-(N-methylsulphamoyl)phenyl]azo]-3-oxobutyramidato(2-)]cobaltate(1-)

Endpoint summary

Description of key information

LD50 (oral) in rats is greater than 2000 mg/kg body weight.

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:

20 September 1995 - 26 October 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material:
9
- Expiration date of the lot/batch:
June 2000

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
In the original container at room temperature away from direct sunlight.
- Stability under test conditions:
Stable under stated storage condition;
expiration date: JUN-2000
- Stability of the test substance in the solvent/dispersant/vehicle/test medium:
Unknown in bi-distilled water, therefore is excluded from the statement of compliance.

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4 4414 Füllinsdorf / Switzerland
- Age at study initiation: males: 8 weeks; females: 10 weeks
- Weight at study initiation: males: 189.2 - 209.6 g; females: 173.6 - 185.2 g
- Housing:Groups of five in Makrol on type-4 cages with autoclaved standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet:Pelleted standard Kliba 343, Batch no. 65/95 rat maintenance diet ("Kuba", Klingentalmuehle AG, CH-4303 Kaiseraugst) available ad libitum (except for the overnight fasting period prior to dosing). Results of analyses for contaminants are included in the report.
- Water: Community tap water from Füllinsdorf, available ad libitum. Results of bacteriological, chemical and contaminant analyses are included in the report.
- Acclimation period: One week under laboratory conditions, after health examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 42-79
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):12 hours artificial fluorescent light (approx. 100 Lux) / 12 hours dark (light period between 6.00 a.m. to 6.00 p.m.), music during the light period.

In-life phase: 20-SEP-1995 to 04-0CT-1995

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

bi-distilled water

Details on oral exposure:

VEHICLE
- Concentration in vehicle:10 ml/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality

Statistics:

The LOGIT-Model could not be used as no deaths occurred.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths as a result of treatment with the test article.

Clinical signs:

other: Diarrhoea was observed in 2 males from test day 1 to 5 and in all females from test day 1 to 4. No other clinical signs were observed during the observation period.

Gross pathology:

No organ abnormalities were observed at necropsy.

Other findings:

None

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose (LD50) of FAT 20035/D in Wistar rats of both sexes is greater than 2000 mg/kg body weight.

Executive summary:

The test article FAT 20035/D was administered to a group of 5 male and 5 female Wistar rats by oral gavage, at a single dose of 2000 mg test article/kg body weight according to OECD guideline 401 and EU method B.1. Based on the study results, there were no deaths as a result of treatment with the test article. Diarrhea was observed in 2 males from test day 1 to 5 and in all females from test day 1 to 4. No other clinical signs were observed during the observation period. The body weight of the animals was within the normal range for rats of this strain and age. No organ abnormalities were observed at necropsy. So, the mean lethal dose (LD50) of FAT 20035/D after single oral administration to Wistar rats of both sexes, observed over a period of 14 days, is greater than 2000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

GLP compliance guideline 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:

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 Oral Toxicity:

In a GLP-compliant study performed according to OECD guideline 401 the test article FAT 20035/D was administered to a group of 5 male and 5 female Wistar rats by oral gavage, at a single dose of 2000 mg test article/kg body weight according to OECD guideline 401 and EU method B.1. Based on the study results, there were no deaths as a result of treatment with the test article. Diarrhea was observed in 2 males from test day 1 to 5 and in all females from test day 1 to 4. No other clinical signs were observed during the observation period. The body weight of the animals was within the normal range for rats of this strain and age. No organ abnormalities were observed at necropsy. So, the mean lethal dose (LD50) of FAT 20035/D after single oral administration to Wistar rats of both sexes, observed over a period of 14 days, is greater than 2000 mg/kg.

In another two supporting studies, the acute oral LD50 in rats was established to be >2000 and >11260 mg/kg, respectively.

 

Acute inhalation Toxicity:

Currently, no study to assess acute inhalation toxicity of Acid Yellow 116 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>2000 mg/kg bw) with no mortality or systemic toxicity, hence it does not need to be classified as STOT SE. Considering the above arguments, low toxicity potential is expected on acute exposure of Acid Yellow 116 via inhalation route.

 

Acute Dermal Toxicity:

Currently, no study to assess the acute dermal toxicity of Acid Yellow 116 is available. However, this substance found to have high molecular weight 927.61 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>2000 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. Considering the above arguments, low toxicity potential is expected on acute exposure of Acid Yellow 116 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 LD₅₀of >2000 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.