Registration Dossier

Administrative data

Description of key information

No adverse effects were seen in an acute oral and an acute dermal toxicity study, performed according to OECD 401 and 402, respectively, at the limit dose of 2000 mg/kg bw.

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:
1998-Mar-24 to 1998-Apr-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstr. 27, D-33178 Borchen
- Age at study initiation: 6-10 weeks
- Weight at study initiation: Male = 203 g; Female = 191 g
- Fasting period before study: from about 16 hours before to 3 - 4 hours after treatment
- 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 RIM-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 dark / 12 hours light
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: received the compound as a 20 % solution in deionized water
- Amount of vehicle (if gavage): 10 ml/kg body weight

DOSAGE PREPARATION (if unusual):
- Reaktiv Rot FC 73270 was dissolved in the stated concentration in deionized water and distributed homogeneously by means of a magnetic stirrer.
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5/sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed frequently on day 1, thereafter twice daily and once on weekends and public holidays; weighed once weekly
- Necropsy of survivors performed: yes
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Red discoloured faeces and diarrhea. Within 2 days all clinical symptoms were reversible.
Body weight:
Development of body weight was not impaired
Gross pathology:
No gross pathology changes.
Interpretation of results:
GHS criteria not met
Conclusions:
The LD0 and LD50 of Reactive Rat FC 73270 in male and female rats is > 2000 mg/kg body weight.
Executive summary:

In an acute oral toxicity study, groups of 6-10 weeks old Hsd:Sprague Dawley rats, 5/sex were given a single oral dose of Reactive Red FC 73270 in deionized water at a dose of 2000 mg/kg body weight and observed for 14 days.

Oral LD0 and LD50:

Male >2000 mg/kg body weight

Female >2000 mg/kg body weight

Combined >2000 mg/kg body weight

 

Reactive Red FC 73270 is of low toxicity based on the LD0 > 2000 mg/kg/d in both male and female Hsd:Sprague Dawley 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:
1998-Apr-01 to 1998-Apr-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmlann, Gartenstrasse 27, 33178 Borchen
- Age at study initiation: 6-10 weeks
- Weight at study initiation: M=259g; F=217g
- Housing: in fully air-conditioned rooms in macrocolon cages (type III) on soft wood granulate, 1 animal per cage
- Diet (e.g. ad libitum): ssniff R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottels, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 50 ± 20%
- 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 30 cm²
- Type of wrap if used: the test substance was moistened on an aluminum foil (6x8 cm) and distributed as uniformly as possible. The foil was held in place with an elastic plaster bandage fixed around the animal's body.

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g Reaktiv Marineblau FC 63805 was moistened with 0.45 ml deionized water
- Constant volume or concentration used: yes
Duration of exposure:
24 h
Doses:
2000 mg/ kg body weight
No. of animals per sex per dose:
5/sex
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 weekend and public holidays only once.
- Necropsy of survivors performed: yes
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Male: 2000 mg/kg body weight; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg body weight; Number of animals: 5; Number of deaths: 0
Clinical signs:
No clinical signs
Body weight:
Development of body weight was not impaired. (All animals gained weight: M=49.4g; F=13.8g)
Gross pathology:
No gross pathology changes
Other findings:
- Other observations: The skin of the animals showed red discolorations up to day 13 of the study.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD0 of Reactive Red FC 73270 for male and female Sprague Dawley rats is >2000mg/kg body weight.
Executive summary:

In an acute dermal toxicity study according to OECD 402, HSD Sprague Dawley rats, 5/sex, were dermally exposed to the test substance in deionized water for 24 hours to 30 cm² of body surface area at a dose of 2000 mg/kg body weight. Animals then were observed for 14 days.

 

The acute dermal toxicity testing in the rat yielded a median lethal dose above 2000 mg/kg body weight in both male and female animals.

After administration of 2000 mg/kg bw neither deaths nor symptoms occurred. The skin surface of the animals was large discoloured red from staining with the test substance. This discolouration had not disappeared up to the end of the study in three animals.

Body weight was above the initial weight during the whole observation period.

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

 

Dermal LD0 and LD50:

Males             >2000 mg/kg body weight

Females          >2000 mg/kg body weight

Combined      >2000 mg/kg body weight

 

Reactive Red FC 73270 is of low toxicity based on LD0 > 2000 mg/kg body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

In acute oral and dermal toxicity studies, groups of 5 Sprague Dawley rats per sex were exposed to a single dose of Reactive Red FC 73270 at 2000 mg/kg body weight. Animals were then observed for 14 days. These experiments were limit tests; no mortalities were observed. For acute dermal toxicity no clinical signs were observed. A red discoloration of the skin was visible for up to 13 days. For acute oral toxicity reversible red colored feces and diarrhea were observed.

The oral and dermal LD50 is >2000 mg/kg body weight. Reactive Red FC 73270 is of low acute toxicity.


Justification for selection of acute toxicity – oral endpoint
An acute oral study was performed according to OECD 401 following GLP guidelines.

Justification for selection of acute toxicity – dermal endpoint
An acute dermal toxicity study was performed according to OECD 402 following GLP guidelines

Justification for classification or non-classification

No adverse effects were observed in an acute oral and dermal toxicity study, performed according to OECD 401 (oral) and 402 (dermal) GLP guidelines.