Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1. November 1989 to 15. November 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to OECD Guideline 401, GLP compliant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Certificate of Analysis: 4921 dated 4. September 1989
Appearence: red powder
- Code: HOE CG 0128 OD ZD71 001
- Analytical purity: 71.2%
- Impurities: sodium chloride, sodium sulphate
- Purity test date: August 1989
- Lot/batch No.: Z 396

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: males: 183 to 191 g; females: 175 to 182 g
- Fasting period before study: 16 hours prior to 3-4 hours after dosing
- Housing: 5 per cage
- Diet: Altromin 1324 ad libitum
- Water: tap water in plastic bottles ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1. Nov To: 15. Nov 1989

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
deionised
Details on oral exposure:
VEHICLE
- Deionised water
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage) 10 mL/kg:
- Justification for choice of vehicle: highly soluble in water


Doses:
2000 mg/kg
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:
- Clinical signs: twice daily - on weekends or public holidays: once daily
- Body weight: weekly
- Necropsy of survivors performed: yes

The prepared test substance was administered by gavage to fasted animals at the stated dosage. The observation period following treatment lasted for 14 days. Symptoms were recorded twice every day (in the morning and in the afternoon), on week-ends and public holidays only once. During this time the animals were weighed weekly. At the end of the observation period the animals were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.
Statistics:
mean and standard deviation of body weight data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths.
Clinical signs:
Reddish discoloration of bedding and feces in males and females on Day 1 and 2. One females showed diarrhea on Day 1. No clinical sings from Day 3 onwards.
Body weight:
No effects on body weight development.
Gross pathology:
No macroscopic findings at necropsy.
Other findings:
None reported

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results obtained in this study, the oral median lethal dose value (LD50) of Reaktiv-Rot F-66 813 FW for the male and female rat is greater than 2000 mg/kg bw.
Executive summary:

Acute oral toxicity testing of Reaktiv-Rot F-66 813 FW in the rat yieldeda median lethal dose (LD50) above 2000 mg/kg bw in both male and female rats. After administration of 2000 mg/kg bw no deaths occurred. Discolored feces and tray/bedding was observed. One female showed diarrhea. On day three of the study all symptoms were reversible.

Development of body weight was not impaired.

The animals killed at the end of the observation period showed no macroscopically visible changes. The substance is not classified for oral toxicity.