trisodium 4-hydroxy-6-(sulfonatomethylamino)-5-(2-(2-sulfatoethylsulfonyl)phenylazo)naphthalene-2-sulfonate

Endpoint summary

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:

November 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted 1996

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source: BRL, Biological Research Laboratories Ltd. Wolferstrasse 4, CH-4414 Fullinsdorf/Switzerland
Age when treated: males: 8 weeks, females: 10 weeks
Body weight range: males (197.1-207.7 g), females (171.8-181.8 g)
Identification: by unique cage number and corresponding color-coded spots on the tail
Acclimatization: one week under laboratory conditions after health examination

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

bi-distilled water

Details on oral exposure:

Test article preparation
The test article was placed into a glass beaker on a tared Mettler PM 460 balance and the vehicle (bi-distilled water) was added. A weight by volume dilution was prepared using a magnetic stirrer as homogenizer. Homogeneity of the test article in vehicle was maintained during treatment.
The preparation was made shortly before dosing.
During formulation trials performed before treatment start, the test substance was readily soluble in bi-distilled water.
The animals received a single dose of the test substance on a mg/kg body weight basis by oral gavage following fasting for approximately 16.5 hours, but with free access to water. Food was provided again approximately 3 hours after dosing.

Application volume/kg body weight 10 mL

Doses:

Dose/kg body weight: 2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

Observations
Mortality/viability: four times during test day 1 and once daily for surviving animals during days 2-15
Body weights: on test day 1 (pre-administration), 8and 15 for surviving animals.
Clinical signs: each animal was examined for changes in appearance and behavior four times during day 1, and once daily for surviving animals during days 2-15. All abnormalities were recorded.

Pathology
Necropsies were performed by experienced prosectors. At the end of the observation period all animals were sacrificed by intraperitoneal injection of Narcoren (Rhone Merieux GmbH) at a dose of at least 2.0 mL/kg body weight (equivalent to at least 320 mg sodium pentobarbitone/kg body weight). The animals were examined macroscopically and all abnormalities recorded. Thereafter, they were discarded.

Statistics:

No statistical analysis was used as no deaths occurred.

Key result

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:

None

Clinical signs:

other: No clinical signs noted

Gross pathology:

No findings noted

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the oral LD50 (gavage) of the test substance was found to be >2000 mg/kg bw in male and female rats.

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance in HanIbm: WIST (SPF) rats according to OECD Guideline 423 and EU Method B.1, in compliance with GLP. One group of 3 females and 3 males were dosed with 2000 mg/kg bw of the test substance. The animals were observed through 14 d. The following observations and examinations were performed: mortality / viability, clinical signs, body weight, clinical pathology and macroscopy at termination. Concentration, homogeneity and stability in the bi-distilled water used as the vehicle were examined by HPLC. The limit dose of 2000 mg/kg bw did not cause death, evident signs of toxicity or body weight loss during the 14 d long observation period. The test substance found to be homogeneous and stable in bi-distilled water at room temperature (about 20°C) for at least 2 h. Under the study conditions, the oral LD50 of the test substance in rat was > 2000 mg/kg bw (Arcelin, 1998).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 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

Oral

A study was conducted to determine the acute oral toxicity of the test substance in HanIbm: WIST (SPF) rats according to OECD Guideline 423 and EU Method B.1, in compliance with GLP. One group of 3 females and 3 males were dosed with 2000 mg/kg bw of the test substance. The animals were observed through 14 d. The following observations and examinations were performed: mortality / viability, clinical signs, body weight, clinical pathology and macroscopy at termination. Concentration, homogeneity and stability in the bi-distilled water used as the vehicle were examined by HPLC. The limit dose of 2000 mg/kg bw did not cause death, evident signs of toxicity or body weight loss during the 14 d long observation period. The test substance found to be homogeneous and stable in bi-distilled water at room temperature (about 20°C) for at least 2 h. Under the study conditions, the oral LD50 of the test substance in rat was > 2000 mg/kg bw (Arcelin, 1998).

Justification for classification or non-classification

Based on the results of an acute oral toxicity study in rats, the substance does not require classification for this endpoint according to CLP (EC 1272/2008) criteria.