4,4'-[(6-chloro-1,3,5-triazine-2,4-diyl)diimino]bis[5-hydroxy-6-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonic] acid, sodium salt

Endpoint summary

Description of key information

The test substance is practically non-toxic

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:

07. October 1992 to 21. October 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: males: 183 to 194 g; females: 174 to 185 g
- Fasting period before study: 16 hours prior to 3-4 hours after dosing
- Housing: 5 per cage
- Diet: Altromin 1324 ad libitum
- Water: tap water in plastic bottles ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 35 to 75
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 07. Oct To: 21. Oct 1992

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

deionised

Details on oral exposure:

VEHICLE
- Deionised water
- Justification for choice of vehicle: highly soluble in water

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Clinical signs: twice daily - on weekends or public holidays: once daily
- Body weight: weekly
- Necropsy of survivors performed: yes

The prepared test substance was administered by gavage to fasted animals at the stated dosage. The observation period following treatment lasted for 14 days. Symptoms were recorded twice every day (in the morning and in the afternoon), on week-ends and public holidays only once. During this time the animals were weighed weekly. At the end of the observation period the animals were killed, dissected and examined for macroscopically visible changes.

Statistics:

mean and standard deviation of body weight data

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths.

Clinical signs:

other: During the first day of the study dark red discolored bedding and feces were noted.

Gross pathology:

No abnormalities detected.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results obtained in this study, the oral median lethal dose value (LD50) of Reaktiv-Rot F-67787 for the male and female rat is greater than 2000 mg/kg bw.

Executive summary:

Acute oral toxicity testing of Reaktiv-Rot F-67787 in the Wistar rat yielded a median lethal dose (LD50) above 2000 mg/kg bw in both male and female rats.

No signs of intoxication were observed after the application of 2000 mg/kg bw Reaktiv-Rot F-67787. No deaths occurred.

During the first day of the study dark red discolored feces and bedding were noted.

Development of body weight was not impaired.

The animals killed at the end of the observation period showed no macroscopically visible changes. The substance is not classified for oral toxicity.

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

Justification for classification or non-classification

The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for acute effects is therefore required.