Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998-Jan-29 to 1998-Feb-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Reaktiv Marineblau FC 63805

Test animals

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 = 170 g; Female = 162 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

Administration / exposure

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 Marineblau FC 63805 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 twice daily and once on weekends and public holidays; weighed once weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
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:
Blue discoloured faeces and diarrhea. Within 2 days all clinical symptoms were reversible.
Body weight:
No changes in the bodyweigth development.
Gross pathology:
No gross pathology changes.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of Reactive Navy FC 63805 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 Navy FC 63805 in deionized water at a dose of 2000 mg/kg body weight and observed for 14 days.

Oral LD50:

Male = >2000 mg/kg body weight

Female= >2000 mg/kg body weight

Combined = >2000 mg/kg body weight

 

Reactive Navy FC 63805 is of low toxicity based on the LD50 > 2000 mg/kg/d in both male and female Hsd:Sprague Dawley rats.