Disodium 4-hydroxy-3-[[2-methoxy-5-methyl-4-[(4-sulphonatophenyl)azo]phenyl]azo]-7-(phenylamino)naphthalene-2-sulphonate

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:

other: read across from similar substance

Adequacy of study:

key study

Study period:

2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

yes

Remarks:

No analysis of the test item formulation

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: ENVIGO laboratories
- Health: rats were submitted to a sanitary control.
- Age at study initiation: 8-12 weeks
- Housing: 4 rats in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: free access to specific food. No food on the night before the test and for 3/4 hours after dosing.
- Water: tap water ad libitum. No water on the night before the test and for 3/4 hours after dosing.
- Acclimatation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 30-70%
- Air changes (per hr): 15 air changes
- Photoperiod (hrs dark / hrs light): 12/12 by timer

Route of administration:

oral: gavage

Vehicle:

water

Doses:

300 and 2000 mg/Kg bw

No. of animals per sex per dose:

1 female at 2000 mg/kg
5 female at 300 mg/kg

Control animals:

not specified

Details on study design:

- Administration: oral administration by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fatsed bw at the time of the dosing.
- Duration of observation period following administration: up to 14 days
- Frequency of observations: In the first day frequent observations (30 min, 1, 2 and 4 hours), and then, once every working day
- Sacrifice: cervical dislocation
- Necropsy performed: gross necroscopy

Preliminary study:

1 female was trated with a dose of 2000 mg/kg bw. Due to mortality at this dose level, a 300 mg/kb bw was chosen for the fixed dose test.

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Mortality at 2000 mg/Kg bw was observed 1 day after dosing.
No mortality at 300 mg/kg bw.

Clinical signs:

There were no signs of systemic toxicity noted at a dose level of 300 mg/kg. Purple colored staining of the urine was noted in the animai treated at a dose level of 2000 mg/kg.
Black/purple colored staining of the feces was noted in the cage of the four additional animals treated at a dose level of 300 mg/kg.

Body weight:

Normal body weight variation

Gross pathology:

Abnormalities noted at necropsy of the animai treated at a dose level of 2000 mg/kg were abnormally red lungs, dark liver, dark kidneys, dark purple coloured substance present in the stomach and purple colored staining of the small intestine. No abnormalities were noted at necropsy of animals treated at a dose level of 300 mg/kg.

Other findings:

No abnormalities were observed

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

LD50 oral rat = 300-2000 mg/Kg bw.

Executive summary:

Based on the effects observed in the test, the LD50 value is 300 -2000 mg/kg bw. The substance needs to be classified as Acute Tox. Oral 4, H302 (Harmful if swallowed) based on the criteria in the Regulation (EC) No. 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

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

Based on the test result for acute oral toxicity, the tested substance is considered as harmful for oral route with a LD50 between 300 and 2000 mg/kg bw.

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:

For Acute toxicity oral route:

Category 1: ATE <= 5 mg/kg bw

Category 2: 5 < ATE <= 50 mg/kg bw

Category 3: 50 < ATE <= 300 mg/kg bw

Category 4: 300 < ATE <= 2000 mg/kg bw

The LD50 of the test substance was determined to be between 300 and 2000 mg/kg bw in the test and the test substance needs to be classified for Acute toxicity by oral exposure in category 4 with the hazard statement H302, Harmful if swallowed.