5-[[4-chloro-6-[(3-sulphophenyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[[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:

December 08, 1998 to December 29, 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

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: HARLAN WINKELMANN
- Age at study initiation: 6-10 weeks
- Weight at study initiation: Mean weight - Males; 194g (189-199g), Females; 179g (169-190g)
- Fasting period before study: from about 16 hours before
- Housing: in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet (e.g. ad libitum): ssniff® R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least seven days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 (± 3°C)
- Humidity (%): 50 (± 20 %)
- Photoperiod (hrs dark / hrs light): 12 hours daily

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

Deionised

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): 80%
- Justification for choice of vehicle: No data

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg body weight

Doses:

2000 mg/kg body weight

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: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During this time the animals were weighed weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the whole study.

Clinical signs:

other: stilted gait, ataxia, squatting posture, irregular respiration, diarrhea and red discolored feces.

Gross pathology:

The animals killed at the end of the observation period showed no macroscopically visible changes.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results obtained in this study the median lethal dose value (LD50) of the substance for the male and female rat is greater than 2000 mg/kg body weight.

Executive summary:

Acute oral toxicity testing of Reactive Red 198 in the rat yielded a median lethal dose (LD50) above 2000 mg/kg body weight in both male and female animals. No lethality occurred after application of 2000 mg/kg body weight. Beside unspecific symptoms the animals showed impairments of motility and respiration. Additionally diarrhea and red discolored feces were observed. At day seven of the study the irritations were reversible. Development of body weight was not impaired. The animals killed at the end of the observation period showed no macroscopically visible changes. Based on the results obtained in this study the median lethal dose value (LD50) of the substance for the male and female rat is greater than 2000 mg/kg body weight.

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

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 November to 16 November 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

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: 6 to 7 weeks
- Weight at study initiation: males: 203 to 214 g; females: 189 to 198 g
- Housing: single
- 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 (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2. Nov To: 16. Nov 1989

Type of coverage:

occlusive

Vehicle:

physiological saline

Details on dermal exposure:

1 g test compound moistened with 0.8 ml 0.9% NaCl-solution was applied to a shaved skin area of approximately 30 cm2

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

not required

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

Prior dermal treatment the fur was removed mechanically from the dorsal skin of the animals over an area of approximately 30 cm2.

The adequate amount of the test substance was pasted and evenly spread on sheets (size 6x8 cm) of aluminium foil. Afterwards the foil covered with test compound was applied to the shaved and intact dorsal skin and fixed with an elastic plaster bandage (Fixomull and Elastoplast, width 8 cm, Beiersdorf AG) wrapped around the animal's body.

After the end of the 24 hours dermal exposure period the bandage was removed and the treated skin area rinsed with lukewarm water to wash off any non-absorbed remnants of the test compound.

The observation period after treatment was 14 days. Clinical symptoms were recorded twice daily (morning and afternoon), on weekends and public holidays only once a day. Body weight development was determined weekly. At the end of the observation period the animals were killed by CO2 asphyxiation, dissected and examined for macroscopically visible changes.

Statistics:

mean and standard deviation of body weight data

Preliminary study:

Not applicable

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No Deaths occured.

Clinical signs:

other: No clinical signs were observed in male and female rats during the whole course of study. Only the surface of the skin was red discolored to a smaller or larger extend.

Gross pathology:

No macroscopically visible changes were observed in all animals killed at end of the observation period.

Other findings:

None

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results obtained in this study, the dermal median lethal dose value (LD50) for the male and female rat is greater than 2000 mg/kg bw.

Executive summary:

Acute dermal toxicity testing of structural analogue 01 in the rat yielded a dermal median lethal dose (LD50) above 2000 mg/kg bw in both male and female rats. After administration of 2000 mg/kg bw neither deaths nor clinical signs occurred. Only the surface of the skin was red discolored to a smaller or larger extend. Development of body weight was not impaired. The animals killed at the end of the observation period showed no macroscopically visible changes.

Based on the results obtained in this study, the dermal median lethal dose value (LD50) for the male and female rat is greater than 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Testing on the above endpoints gave the following results:

 Acute toxicity: Oral.

-         LD50: >2000 mg/kg

Acute toxicity: Dermal.

-         LD50: >2000 mg/kg

Acute toxicity: Inhalation.

Not measured.

 

The test substance has a presumed very low vapour pressure and is a granular product; hence the potential for the generation of inhalable forms is low. In addition, production and use is done in a closed process without isolation of reaction products. The isolated product are dust free granules (non-dusty solid) which may be formulated into a liquid preparation of low volatility and the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. Dermal exposure is considered to be the appropriate route of exposure and has been assessed accordingly. No acute inhalation test was performed.

The following information is taken into account for any hazard / risk assessment:

Oral, inhalation and dermal acute toxicity are all considered.

Value used for CSA:

LD50 (oral): 2000 mg/kg bw

LD50 (dermal): 2000 mg/kg bw

Justification for classification or non-classification

The above studies have all been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP and in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.

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.