Reaction mass of copper complex of [(2,6-difluoroheterocycl-4-yl)amino]hydroxy{[2-hydroxy-3-sulfonato-5-(vinylsulfonyl)phenyl]diazenyl}naphthalene sulfonic acid, dialkali salt and copper complex of [(2,6-difluoroheterocycl-4-yl)amino]-hydroxy{[2-hydroxy-3-sulfonato-5-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl]diazenyl}naphthalene sulfonic acid, trialkali salt

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003-Feb-18 to 2003-Mar-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Conducted in accordance with OECD 423 Acute oral toxicity under GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

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 the study report): Reaktiv Rot F00-0124

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann, Gartenstr. 27, D-33178 Borchen
- Age at study initiation: 6-10 weeks
- Weight at study initiation: 180 ± 6.8 g
- Housing: MacroIon cages (type 4) on soft wood granulate in groups of 3 animals per cage
- Diet (e.g. ad libitum): ssnif R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): Tap water in plastic bottles, ad libitum
- Acclimation period: At least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 50±20 °C
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE:
- concentration in vehicle: 20% suspension
- Amount of vehicle (if gavage): 10 mL/kg body weight

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends
and public holidays only once. The animals were weighed weekly.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Female: 2000 mg/kg body weight; Number of animals: 6; Number of deaths: 0

Clinical signs:

10-30 minutes after administration: stilted and uncoordinated gait, squatting posture, irregular respiration, diarrhea and feces, anal region and tray bedding were discolored (reddish).
From day 4 until end of the study no symptoms 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 median LD50 of Reactive Red F00-0124 for female HSD Sprague Dawley rats is >2000mg/kg body weight.

Executive summary:

In an acute oral toxicity study, a group of 6 female Hsd:Sprague Dawley Rats aged 6-10 weeks, were given a single oral dose of Reactive Red F00-0124 in deionized water at a dose of 2000 mg/kg body weight and observed for 14 days.

 

Oral LD50

Female = >2000 mg/body weight

 

Reactive Red F00-0124 is of Low toxicity based on the LD50 in female rats.