Hexasodium 4,4'-[1,4-phenylenebis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino]]bis[5-hydroxy-6-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate]

Endpoint summary

Description of key information

Five rats/sex received a single oral dose of the substance at 4175 mg/kg bw (vehicle water). No effects on mortality and clinical signs were reported during the 14 day observation period. Necropsy showed reddish discoloration of the kidney. The LD50 is > 4175 mg/kg bw (Ciba 1974). This finding of very low toxicity is confirmed in two additional studies, both indicative for a LD50 of > 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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non GLP study, information limited to what is included in the summary

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: bred on premises
- Age at study initiation: 6 weeks
- Average weight at study initiation: males 196g/ females 149g
- Fasting period before study: 18 hour
- Housing: individually
- Diet: pelleted diet (Oakes Special Diet with added Vit.E ) ad libitum
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21± 2 °C
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 33.3% (0.835 * 33.3= 27.8% ai)

MAXIMUM DOSE VOLUME APPLIED: 15 mL/kg

Doses:

5000 mg/kg bw (4175 mg/kg bw as ai)

No. of animals per sex per dose:

5 males + 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, clinical signs and body weight

Statistics:

NA

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 175 mg/kg bw

Based on:

act. ingr.

Mortality:

none

Clinical signs:

none

Body weight:

no data

Gross pathology:

reddish staining of the kidney

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the substance is > 4175 mg/kg bw

Executive summary:

Five rats/sex received a single oral dose of the substance at 4175 mg/kg bw (vehicle water). No effects on mortality and clinical signs were reported during the 14 day observation period. Necropsy showed reddish discoloration of the kidney. The LD50 is > 4175 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

4 175 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

The acute dermal toxicity study has been waived based on low acute toxicity. A prediction with the OECD toolbox has been included in section 13 (Cramer class 1).

Justification for classification or non-classification

Based on the available data the substance does not need to be classified for acute toxicity according to Regulation ((EC) No 1272/2008 (CLP)