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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From September 27, 2004 to October 14, 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
457-630-8
EC Name:
-
Cas Number:
2041206-19-1
Molecular formula:
Hill formula: C29H23FN8Na4O16S5
IUPAC Name:
Tetrasodium 3-amino-4-(4-(4-fluoro-6-(phenyl-(2-(2-sulfonyld ioxyethylsulfonyl)-ethyl)-amino)-1,3,5-triazin-2-ylamino)-2- sulfonato-phenylazo)-5-hydroxy-naphthalene-2,7-disulfonate
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstrasse 27, D-33178 Borchen.
- Age at study initiation: 6 to 10 weeks
- Body weight range at treatment: 178-191 g
- Housing: In transparent macrolon cages (type IV) on soft wood granulate in an air-conditioned room, 3 animals per cage
- Diet: Ssnif R/M-H (V 1534), ad libitum
- Water: Tap water in plastic bottles, ad libitum
- Acclimation period: At least 5 d
- Animal identification: Fur marking with KMnO4 and cage numbering
- Randomization procedure: Computer generated algorithm (archived with raw data) Randomization scheme 2004.0213

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C (short lasting deviations are permissible, e.g., during cleaning processes)
- Humidity: 50±20% (short lasting deviations are permissible, e.g., during cleaning processes)
- Photoperiod: 12 h light/dark cycle

IN-LIFE DATES: From: To: September 27, 2004 to October 14, 2004

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
deionized
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20% solution in deionized water

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION (if unusual): Test substance was dissolved in the stated concentration in deionized water and distributed homogeneously by means of a magnetic stirrer. The stability and the homogeneity of the test substance in the vehicle was determined by analytical methods.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Limit test (according to toxicity data of related compounds).
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
six (female only)
Control animals:
no
Details on study design:
TEST PROCEDURE
The prepared test substance was administered by gavage to fasted animals at the stated dosage. The observation period following treatment lasted for 14 d. Symptoms were recorded twice every day (i.e., in the morning and in the afternoon), on weekends 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.

Results and discussion

Effect levels
Key result
Sex:
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:
No deaths occurred during the whole study.
Clinical signs:
Reddish discolored urine and feces were observed in the animals starting 2-4 h after the administration of test substance. From Day 3 until the end of the study no symptoms were observed.
Body weight:
Development of body weight was not impaired.
Gross pathology:
The animals killed at the end of the observation period showed no macroscopically visible changes.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the oral LD50 was found to be >2000 mg/kg bw in rats.
Executive summary:

A study was conducted to assess the acute oral toxicity of the test substance in female Hsd:Sprague Dawley (SD) rats according to OECD Guideline 423 and EU Method B.1, in compliance with GLP.

Group of six female fasted rats received a single oral (gavage) dose of 2000 mg/kg bw. A 20% solution of test substance was prepared in deionized water and administered at a volume of 10 mL/kg bw.

 

No mortality occurred, no effect on body weight was observed and no significant macroscopic abnormalities were seen at necropsy. Reddish discolored urine and feces were observed after the administration of test substance for up to 2 d. There were no further symptoms from Day 2 until end of the study.

 

Under the study conditions, the oral LD50 was found to be >2,000 mg/kg bw in rats.