Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 23, 2006 - November 14, 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study has been performed in accordance with OECD 423 (2001) and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(2001)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Leuchtstoffmuster L 130
- Appearance: light green microcrystalline solid
- Storage condition of test material: at room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
- Source: Harlan Winkelmann GmbH, Gartenstrasse 27, 33178 Borchen, Germany
- Age at study initiation: no data
- Weight at study initiation:
Group 1: 194-211 g (mean: 203.67 g)
Group 2: 182-195 g (mean: 186.67 g)
- Body weight variation: less than 20% of the mean weight
- Housing: individually in Makrolon cages
- Diet: SDS RM1 Nagerfutter, Withham Essex, England. Twice 8 g daily.
- Water: Free access to tap water
- Acclimation period: 5 days
- Fasting period before study: overnight before the day of administration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 – 25
- Humidity (%): 30 - 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
(1 mL)
Details on oral exposure:
DOSE VOLUME APPLIED:
Group 1: 389-422 mg/rat (dissolved in 1 mL water)
Group 2: 364-390 mg/rat (dissolved in 1 mL water)

DOSAGE PREPARATION:
Calculated amounts of the test material according to the dosage of 2000 mg/kg bw were dissolved in 1 mL water and administered to the rats in a single dose with the aid of a stomach tube.

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 (2 groups of three females in a stepwise manner)
Control animals:
other: not required
Details on study design:
- Animals were deprived of food overnight prior to dosing and until 4 hours after administration of the test substance. Water was available ad libitum.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: daily
Body weights: daily
Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- 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.
Remarks on result:
other: No mortalities and no clinical signs of toxicity occurred
Mortality:
Group 1: No mortalities occurred.
Group 2: No mortalities occurred.
Clinical signs:
No clinical signs of toxicity occurred in any of the animals.
Body weight:
No abnormalities occurred in any of the animals.
Gross pathology:
Macroscopic examination of the animals did not reveal any abnormalities.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute oral toxicity study in female rats with the substance, conducted in accordance with OECD 423 (2001) and according to GLP principles, a LD50 oral of >2000 mg/kg was determined.
Executive summary:

The acute oral toxicity of the substance in female rats has been studied in accordance with OECD 423 (2001) and according to GLP principles. The substance was dosed in water at 2 g/kg bw in 6 female rats, in 2 steps. No mortalities and no clinical signs of toxicity occurred in any of the animals. Necropsy did not show any abnormality. The acute oral toxicity (LD50) was determined to be >2000 mg/kg bw. Based on this result, the substance does not need to be classified for acute toxicity by the oral route.