Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From June 29, 1999 to July 13, 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD Guideline 401 and EU Method B.1, in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

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
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Name of test material (as cited in study report): Reaktiv Orange F97-0318

Test animals

Species:
rat
Strain:
other: HSD: Sprague Dawley SD
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, Gartenstr. 27, 33178 Borchen, SPF breeding colony.
- Age at study initiation: 6-10 weeks
- Body weight range at treatment: Males: 192-204 g; Females: 182-192 g
- Housing: In fully air-conditioned rooms in macrolon cages (i.e., type 4) on soft wood granulate in groups of 5 animals
- Diet: Ssnif R/M-H (V 1534), ad libitum
- Water: Tap water in plastic bottles, ad libitum
- Acclimation period: At least 7 d
- Animal identification: Fur marking with KMnO4 and cage numbering
- Randomization procedure: Randomization schemes 98.0691, 98.0690
- Withdrawal of food: From about 16 h before to 3-4 h after treatment

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

IN-LIFE DATES: From: To: June 29, 1999 to July 13, 1999

Administration / exposure

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

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

PREPARATION OF THE TEST SUBSTANCE: Test substance was suspended 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
Doses:
2,000 mg/kg bw
No. of animals per sex per dose:
Five/sex/dose
Control animals:
not specified
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 (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
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the whole study.
Clinical signs:
Irregular respiration, diarrhea and orange discolored feces were observed after the administration of test substance.
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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the study conditions, the oral LD50 was found to be >2,000 mg/kg bw in rats.
Executive summary:

A study was conducted to assess the acute oral toxicity of the test substance in HSD:Sprague Dawley rats according to OECD Guideline 401 and EU Method B.1, in compliance with GLP.

 

Groups of five female and five male fasted rats received a single oral (gavage) dose of 2,000 mg/kg bw. A 20% suspension 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. Irregular respiration, diarrhea and orange discolored feces were observed after the administration of the test substance.

 

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