Benzoic acid, 2-hydroxy-5-[[4-[[4-[[8-hydroxy-7-[[4-[(8-hydroxy-3,6-disulfo-1-naphthalenyl)azo]-2-methoxy-5-methylphenyl]azo]-3,6-disulfo-1-naphthalenyl]amino]-6-(phenylamino)-1,3,5-triazin-2-yl]amino]phenyl]azo]-, pentasodium salt

Endpoint summary

Description of key information

LD50 = 3800 mg/kg in rats.

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:

supporting study

Study period:

From April 17 to May 14, 2007

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

2001

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Route of administration:

oral: gavage

Vehicle:

arachis oil

Doses:

300 and 2000 mg/kg

No. of animals per sex per dose:

1 female: 300 mg/kg
5 females: 2000 mg/kg

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, body weight changes

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality at 300 and 2000 mg/kg.

Body weight:

Body weight gains were as expected.

Other findings:

No signs of systemic toxicity at 300 and 2000 mg/kg.
At 2000 mg/kg, black stained faeces were noted up to 4 days after treatment.

Interpretation of results:

other: not classified according to the CLP Regulation (EC 1272/2008)

Conclusions:

LD50 > 2000 mg/kg in rats.

Executive summary:

Method

Female rats were dosed by gavage with 300 and 2000 mg/kg as single oral dose. Observations were continued up to 14 days after dosing. Mortality and clinical signs were recorded. At the end of the observation period, all animals were subjected to gross necropsy.

Results

LD50 > 2000 mg/kg.

At both dose levels, there were no deaths and signs of systemic toxicity. Black stained faeces were noted for up to 4 days after dosing.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

3 800 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

Two studies on acute toxicity of the substance were available. In both studies, test samples were administered by gavage to rats.

In the key study, doses from 2500 to 4200 mg/kg were tested and an LD50 = 3800 mg/kg was identified.

In the supporting study, doses of 300 and 2000 mg/kg were tested according to OECD guideline 420. No mortality was recorded.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), substances can be allocated to one of four toxicity categories based on acute toxicity by oral, dermal or inhalation route according to 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 3800 mg/kg bw, therefore the test substance is above the classification threshold for acute oral toxicity (Category 4: 300 < ATE ≤ 2000 mg/kg).