Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to
Guideline:
other: EC Regulation No. 84/449 (L 251, 96)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
No abnormal clinical signs were observed.
Body weight:
Development of body weight was not impaired.
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.