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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07. October 1992 to 21. October 1992
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:
1993
Report date:
1992

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
4,4'-[(6-chloro-1,3,5-triazine-2,4-diyl)diimino]bis[5-hydroxy-6-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonic] acid, sodium salt
EC Number:
303-152-9
EC Name:
4,4'-[(6-chloro-1,3,5-triazine-2,4-diyl)diimino]bis[5-hydroxy-6-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonic] acid, sodium salt
Cas Number:
94158-79-9
Molecular formula:
C39H32ClN9O26S8.xNa C39H26ClN9Na6O26S8 as hexasodium salt
IUPAC Name:
4,4'-[(6-chloro-1,3,5-triazine-2,4-diyl)diimino]bis[5-hydroxy-6-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonic] acid, sodium salt
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Reaktiv-Rot F-67787

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: males: 183 to 194 g; females: 174 to 185 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 (%): 35 to 75
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 07. Oct To: 21. Oct 1992

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
deionised
Details on oral exposure:
VEHICLE
- Deionised water
- 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, 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:
During the first day of the study dark red discolored bedding and feces were noted.
Body weight:
Development of body weight was not impaired.
Gross pathology:
No abnormalities detected.
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-67787 for the male and female rat is greater than 2000 mg/kg bw.
Executive summary:

Acute oral toxicity testing of Reaktiv-Rot F-67787 in the Wistar rat yielded a median lethal dose (LD50) above 2000 mg/kg bw in both male and female rats.

No signs of intoxication were observed after the application of 2000 mg/kg bw Reaktiv-Rot F-67787. No deaths occurred.

During the first day of the study dark red discolored feces and bedding were noted.

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.