Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: Product no. B4429, Lot no. SLBK5235V
- Expiration date of the lot/batch: 30 April 2018
- Purity test date: na

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no

Test animals

Species:
rat
Strain:
other: Crl:WI
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: TOXI COOP ZRT. Cserkesz u. 90., 1103 Budapest, Hungary
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks
- Weight at study initiation: 199 - 201 g
- Fasting period before study: 1 day
- Housing: group caging (3 rats/cage)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5-6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): approx. 10/h
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10mL/kg bw
- Justification for choice of vehicle: standard vehicle
- Lot/batch no. (if required):
- Purity: aqua purificata Ph.Hg. VIII. from Parma Produkt Kft.

MAXIMUM DOSE VOLUME APPLIED: 2 mL

DOSAGE PREPARATION (if unusual): not applicable

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Selection was based on the basis of the available information about the test item and similar substances
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: rats were observed at least twice daily and weighted on days 0, 7 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, appearance of tissue and organs
Statistics:
not applicable

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
2000 mg/kg bw: 0 of 6
Clinical signs:
none
Body weight:
normal development
Gross pathology:
no changes found
Other findings:
none

Any other information on results incl. tables

In a GLP-study according to OECD TG 423 (acute class method) with rats, the LD50 of the substance was determined as > 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

The acute oral toxicity of the substance was investigated in a GLP study according to OECD TG 423.

All six female rats treated with 2000 mg/kg bw by oral gavage survived the observation period of 14 days, showing no clinical signs, no pathological changes and normal body weight development.

According to the results of this study the substance is not classified for acute toxicity according to CLP-Regulation (EC) No 1272/2008.