C.I. Reactive Blue 224

Endpoint summary

Description of key information

An acute oral and dermal toxicity study were performed according to the EC guideline 84/449, which is similar to the OECD guidelines.

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:

1985-Aug-13 to 1985-Aug-27

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to EC guideline 84/449, which is similar to OECD 401.

Qualifier:

according to guideline

Guideline:

other: EC Regulation No. 84/449 (L 251, 96)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

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: Winkelmann, Borchen, SPF breeding colony
- Age at study initiation: 9 weeks (Male) to 14 weeks (Female)
- Weight at study initiation: Male=176 g; Female 172 g
- Fasting period before study: 16 h
- Housing: macrocolon cages (type III) on wood granulate, in groups of 5 animals per cage
- Diet (e.g. ad libitum): Altromin R 1324, ad libitum (except 16h before to 4h after substance application)
- Water (e.g. ad libitum): Water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 10%
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Animals obtained one single dose of 5000 mg of Reactive Blue FC 15353 per kg bodyweight by gavage using a rigid metal stomach tube. The total application volume was 20 ml per kg of bodyweight.

Doses:

5000 mg Reactive Blue FC 15353 per kg bodyweight, corrseponding to an applied volume of 20 ml/kg of the prepared solution.

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: Symptoms were recorded twice every day; on weekend and public holidays only once. Animal weighing: 1/week
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

Male: 5000 mg/kg body weight; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg body weight; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: No abnormal clinical signs were observed.

Gross pathology:

No gross pathology changes

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of Reactive Blue FC 15353 for male and female Wistar rats is >5000 mg/ kg body weight.

Executive summary:

In an acute oral toxicity study, groups of 16 hours fasted 9 (male) to 14 (female) weeks old Wistar rats, 5/sex were given a single oral dose of Reactive Blue FC 15353 in water by gavage at a dose of 5000 mg/ kg body weight and observed for 14 days.

 

Oral LD50

Males = >5000 mg/kg body weight

Females = >5000 mg/kg body weight

Combined = >5000 mg/kg body weight

 

Reactive Blue FC 15353 is of LOW toxicity based on the LD50 > 5000 mg/kg body weight in male and female rats.

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

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 1985-Aug-20 to 1985-Sep-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performed according to EC guideline 84/449, which is similar to OECD 402.

Qualifier:

according to guideline

Guideline:

other: EC-directive 84/449 (L251,96)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

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: Winkelmann, Borchen, SPF breeding colony
- Age at study initiation: 9 weeks (male) to 14 weeks (female)
- Weight at study initiation: 180 g (male), 184 g (female)
- Housing: macrolon cages (type III) on wood granulate, in groups of 5 animals/cage
- Diet (e.g. ad libitum): Altromin R 1324, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2 °C
- Humidity (%): 50±10 %
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: approximately 10% skin surface
- Type of wrap if used: aluminum foil and fixed with non-irritating plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 ml/kg body weight
- For solids, paste formed: yes - using water

Duration of exposure:

24 h

Doses:

5 ml/kg body weight

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: Symptoms recorded twice every day (once on weekends and public holidays); animals were weighed weekly
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Mortality:

Male: 2500 mg/kg body weight; Number of animals: 5; Number of deaths: 0
Female: 2500 mg/kg body weight; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: No symptoms were observed.

Gross pathology:

No gross pathological changes

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median LD50 of Reactive Blue FC 15353 for mals and female Wistar rats is >2500 mg/kg body weight.

Executive summary:

In an acute dermal toxicity study, Wistar rats, 5/sex, were dermally exposed to Reactive Blue FC 15353 in deionized water for 24 hours to 10 % of body surface area at a dose of 2500 mg/kg body weight. Animals then were observed for 14 days. No mortality or clinical signs were observed after administration.

Dermal LD50:

Males = >2500 mg/kg body weight

Females = >2500 mg/kg body weight

Combined = >2500 mg/kg body weight

Reactive Blue FC 15353 is of LOW Toxicity based on LD50 > 2500 mg/kg body weight.

 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

In two acute oral and dermal toxicity studies, groups of 5 Wistar rats per sex were given a single dose of Reactive Blue FC 15353 in deionized water at a dose of 5000 mg/kg body weight (oral) or 2500 mg/kg body weight (dermal). Animals were then observed for 14 days. The experiments were limit tests. No mortality or clinical signs were observed after administration.

The oral LD50 is >5000 mg/kg body weight, the dermal LD50 is >2500 mg/kg body weight, therefore, Reactive Blue FC 15353 is of low toxicity.

Justification for selection of acute toxicity – oral endpoint
An acute oral toxicity study was performed according to the EG guideline 84/449, which is similar to the OECD guideline 401.

Justification for selection of acute toxicity – dermal endpoint
An acute dermal toxicity study was performed according to EG regulation No. 84/449 (L251,96)

Justification for classification or non-classification

No adverse effects were observed in an acute oral and dermal toxicity study, performed according to EC guideline 84/449.