Registration Dossier

Administrative data

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:
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
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
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:
No abnormal clinical signs were observed.
Body weight:
Development of body weight was not impaired.
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:
other: EC-directive 84/449 (L251,96)
Qualifier:
equivalent or similar to
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 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:
No symptoms were observed.
Body weight:
Animal development was not disturbed.
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.