Disodium 3-[[2,4-bis(2-methylphenoxy)phenyl]azo]-4-hydroxy-5-[[(p-tolyl)sulphonyl]amino]naphthalene-2,7-disulphonate

Endpoint summary

Description of key information

LD50 oral acute rat > 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:

1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study well documented, test procedure in accordance with 401, meets generally accepted scientific principles, acceptable for assessment. not GLP compliant

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Species:

rat

Strain:

other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif x RII 2/Tif

Sex:

male/female

Details on test animals or test system and environmental conditions:

Initial Body Weight Range: 159-193 gInitial Age: 7-8 weeksIndividual Identification: by colour code using picric acidRat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland), and water were provided ad libitum.The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 3 with standardized soft wood bedding (Société Parisienne des sciures, Pantin).The animal room was air conditionned: temperature 22±3° C, relative humidity 55+15%, 12 hours light/day, approximately 15 air changes/h.

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Doses:

2500, 5000, 7500 mg/kg

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

no

Details on study design:

Pretreatment: The animals were allocated to the different dose groups by random selection. Prior to dosing, the animals were fasted overnight.Administration: oral f by gastric intubation (gavage)Observation Period: 14 days or until all symptoms have disappeared, whichever lasts longerAdministration of the Test Article: one single dose, per osObservations and RecordsMortality: daily, a.m. and p.m. on working daysSigns and Symptoms: dailyBody weight: on days 1, 7, 14 and at deathNecropsies: Spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period.

Statistics:

From the body weights, the group means and their standard deviations were calculated.Where feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944)

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

1/5 female died at 5000 mg/kg dose and 3/5 females died at 7500 mg/kg dose

Clinical signs:

other: no specific symptoms were seen

Gross pathology:

No compound related gross organ changes were observed.

Other findings:

Spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

LD50 in rats of both sexes: >5000 mg/kg bw

Executive summary:

The aim of this study was to determine the acute oral toxicity potency of Acid violet 054 in rats, according to the OECD Guideline 401 (Acute Oral Toxicity).

The test was performed on rats (5 males and 5 females) per dose level, at three dose level: 2500, 5000 and 7500 mg/kg.

The test material was dissolved in distilled water.

The observation period was 14 days or until all symptoms have disappeared, whichever lasts longer

Prior to dosing by gastric intubation, the animals were fasted overnight. After administration, the animals were observed daily for clinical signs and mortality. Body weight was recorded immediately before administration, on day 7 and day 14.

1/5 female died at 5000 mg/kg dose and 3/5 females died at 7500 mg/kg dose. Spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period.

No specific symptoms were seen and Normal weight was gain. No compound related gross organ changes were observed.

Conclusion:following LD50 were determined

LD50 in male rats; >5000 mg/kg bw.

LD50 in female rats; > 5000 mg/kg bw.

LD50 in rats of both sexes; >5000 mg/kg bw

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 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

One study (Huntsman, 1982) has been chosen as key study for acute oral toxicity endpoint.

The test follows OECD 401 and it was performed on Acid violet 054.

The test was performed on rats (5 males and 5 females) per dose level, at three dose level: 2500, 5000 and 7500 mg/kg. 1/5 female died at 5000 mg/kg dose and 3/5 females died at 7500 mg/kg dose.

Spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period.

After the treatment with the tested substance, no specific symptoms were seen and normal weight was gain. No compound related gross organ changes were observed.

The LD50 in rats of both sexes is > 5000 mg/kg bw.

 

Another study (Huntsman, 1975) is available for Acid Violet 054 and was used as supporting. 

No guideline are followed and the tested substance was administered as a single dose of 5 g/kg by gavage to rats .

After administration of the compound, the animals were observed for 14 days.

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.

The acute oral median lethal dose (LD50 ) was found to be greater than 5 g/kg body weight.

 

A summary (Dystar, 1977) is also available for Acid Violet 054, confirming an LD50 > 5 g/kg body weight

Justification for selection of acute toxicity – oral endpoint
The study is well described and assesses the end point completely

Justification for classification or non-classification

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 shown in Table 3.1.1 of CLP Regulation. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE). The limit value that can trigger to Classification is 2000 mg/Kg for oral and dermal exposure pattern and 5 mg/l for inhalation exposure pattern. Based on the consideration in the discussion above, no classification for acute toxicity oral is warranted under Regulation 1272/2008