Reaction mass of Cobaltate(2-), [2-[[[4-hydroxy-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]phenyl]sulfonyl]amino]benzoato(3-)][2-[[2-hydroxy-5-[(phenylamino)sulfonyl]phenyl]azo]-3-oxo-N-phenylbutanamidato(2-)]-, disodium and Cobaltate(3-), bis[2-[[[4-hydroxy-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]phenyl]sulfonyl]amino]benzoato(3-)]-, trisodium and sodium bis[2-[[2-hydroxy-5-[(phenylamino)sulphonyl]phenyl]azo]-3-oxo-N-phenylbutyramidato(2-)]cobaltate(1-)

Endpoint summary

Description of key information

Oral LD50 (male and female) > 2000 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

Remarks:

source of read across

Adequacy of study:

key study

Study period:

From September the 13th to October the 04th, 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted February 24, 1987

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Remarks:

Hanlbm: WIST (SPF)

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
- Fasting period before study: overnight fasting period prior to application.
- Housing: groups of five in Makrol on type-4 cages with autoclaved standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet: a pelleted standard Kliba 343, Batch no. 65/95 rat maintenance diet ("Kuba", Klingentalmuehle AG, CH-4303 Kaiseraugst) available ad libitum.
- Water: community tap water from Füllinsdorf, available ad libitum.
- Acclimation period: one week under laboratory conditions, after health examination.

ENVIRONMENTAL CONDITIONS
- Temperature: 21-23 °C
- Humidity: 42-79 %
- Air changes: 10-15 air changes per hour
- Photoperiod: 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.

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

- Volume dose:10 ml/kg
- Preparation of test article: the test article, previously reduced with a mortar was placed into a glass beaker on a tared Mettler PM 480 balance, and the vehicle (bi-distilled water) was added. Homogeneity of the test article in the vehicle was maintained during treatment using a magnetic stirrer. The preparation was made shortly before dosing.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of mortality / viability recording: four times during test day 1 and daily during days 2-15.
- Frequency of observation: each animal was examined for changes in appearance and behaviour four times during day 1 and once daily during days 2-15. All abnormalities were recorded.
- Frequency of weighing: on test day 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes. At the end of the observation period all animals were anesthetized by intraperitoneal injection of NARCOREN at a dose of at least 2.0 ml/kg body weight (equivalent to at least 320 mg sodium pentobarbitone/kg body weight) and sacrificed by exsanguination. The animals were examined macroscopically.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

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

Clinical signs:

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.

Body weight:

The body weight of the animals was within the normal range for rats of this strain and age.

Gross pathology:

No organ abnormalities were observed at necropsy.

Interpretation of results:

other: not classified, according to the CLP Regulation (EC) No 1272/2008

Conclusions:

LD50 (male and female) > 2000 mg/kg bw

Executive summary:

The acute toxicty of the substance by oral route was investigated in accordance with the OECD guideline 401. The test article was administered to a group of 5 male and 5 female rats by oral gavage, at a single dose of 2000 mg test article/kg body weight.  

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.  

The mean lethal dose after single oral administration to rats of both sexes, observed over a period of 14 days, could not be estimated. Hence, the LD50 resulted to be greater than 2000 mg/kg.

Conclusion

LD50 (male and female) > 2000 mg/kg bw

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

There is no information about the acute toxicity of Acid Yellow 235, thus the available data on structural analogous Similar Substance 01 has been taken into account. The read across approach can be considered as reliable and adequate for the purpose; details and explanations are detailed in the report attached to the IUCLID section 13.2.

The acute toxicity of the Similar Substance 01 by oral route was investigated in accordance with the OECD guideline 401. The test article was administered to a group of 5 male and 5 female rats by oral gavage, at a single dose of 2000 mg test article/kg body weight.  

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.  

The mean lethal dose after single oral administration to rats of both sexes, observed over a period of 14 days, could not be estimated. Hence, the LD50 resulted to be greater than 2000 mg/kg.

Justification for classification or non-classification

According to the CLP Regulation (EC) No 1272/2008, 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

The oral LD50 value was established to be greater than 2000 mg/kg bw, therefore the test substance is out of any classification limit for acute oral toxicity (oral acute toxicity category 4: 300 < ATE ≤ 2000 mg/kg bw).

In conclusion, the test substance does not meet the criteria to be classified for oral acute toxicity, according to the CLP Regulation (EC) No 1272/2008.