Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch: 19B 2059
- Expiration date of the lot/batch: 14 January, 2001
- Purity test date: 14 January, 2000

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Darkness at approximately 20 C in a fume cupboard under inert conditions (N2).
- Solubility and stability of the test substance in the solvent/vehicle: Soluble and guranteed for 4 hours.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test article was emulsified in deionized water and distributed homogeneously by magnetic stirrer. The stability and homogeneity of the test substance in the vehicle was determined by analytical methods.

FORM AS APPLIED IN THE TEST (if different from that of starting material): Emulsified in deionized water.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, Gartenstr. 27, 33178 Borchen SPF breeding colony
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 6-10 weeks
- Weight at study initiation: Meal mean: 199 grams, Female mean: 167 grams
- Fasting period before study: 16 hours prior to treatment and 3-4 hours following treatment
- Housing: Group housed in macrolon (type 4) cages on soft wood granulate
- Diet (e.g. ad libitum): ssniff R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: At least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-25 C
- Humidity (%): 30-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 15 March, 2000 To: 29 March, 2000

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20% emulsion in water
- Amount of vehicle (if gavage): 10 mL/kg body weight
- Justification for choice of vehicle: Test article stability

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight

DOSAGE PREPARATION: The test article was emulisifed in deionized water.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No data
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) and body weghts (weekly) were noted.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred during the study.
Clinical signs:
No abnormal clinical signs were noted during the study.
Body weight:
Body weight gain was not adversely impacted by treatment.
Gross pathology:
No gross abnormalities were noted in any animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of the study, the oral LD50 of the test article is greater than 2000 mg/kg body weight.
Executive summary:

The acute oral toxicity potential of the test article was evaluated in male and female rats. The study was performed in accordance with OECD GLP (1999). The study design was based on OECD 401 (1987). The test article was emulsified at 20% in deionized water. Rats (5/sex) received 2000 mg/kg test article via a single oral gavage. Parameters evaluated: clinical observations (daily), body weights (weekly), and gross necropsy (termination). All animals were terminated 14 days post-dose. All animals survived. There were no abnormalities in clinical observations, body weights, or gross necropsy observations. Based on the results of the study, the oral LD50 of the test article is greater than 2000 mg/kg body weight.