C.I. Reactive Blue 224

Acute Toxicity: oral

Administrative data

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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

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

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Reactive Blue FC 15353

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels

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

Applicant's summary and conclusion

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.