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Administrative data

Description of key information

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.

The subsequent evaluation on the necessity of a acute test via a second route was done in accordance with Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance, Version 6.0, July 2017, p 374f.

Based on the absence of systemic effects after single and repeated oral administration up to the limit dose, a study on acute dermal toxicity is not required.

Therefore, and due to the fact that inhalation is not likely, a study on acute inhalation is not required.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06.09.2005 - 20.10.2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Test material (Batch No. 05030139/131) provided by the sponsor Raschig GmbH
- Expiration date of the lot/batch: not available
- Purity test date: not available

RADIOLABELLING INFORMATION (if applicable): not applicable

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stable
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: highly soluable in water, stable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: none

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: none
- Preliminary purification step (if any): none
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable

FORM AS APPLIED IN THE TEST (if different from that of starting material): not applicable

OTHER SPECIFICS: none
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage JANVIER (53490 Le Genest St Isle, France)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: not available
- Weight at study initiation: 184 - 208 g
- Fasting period before study: not available
- Housing: not available
- Diet (e.g. ad libitum): not available
- Water (e.g. ad libitum): not available
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22 °C
- Humidity (%): 37 - 56%
- Air changes (per hr): not available
- Photoperiod (hrs dark / hrs light): not available

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
distilled
Details on oral exposure:
VEHICLE
- Concentration in vehicle: not available
- Amount of vehicle (if gavage): 5 mL/kg
- Justification for choice of vehicle: not available
- Lot/batch no. (if required): not required
- Purity: not applicable

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg

DOSAGE PREPARATION (if unusual): not applicable

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not available
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
3
Control animals:
yes
Remarks:
6 females
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 4 times (day 0, 2, 7, 14)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: clinical signs
Statistics:
not applicable
Preliminary study:
not applicable
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
none
Body weight:
developed normal (as compared to the control group)
Gross pathology:
no findings

In a GLP-study according to OECD TG 423, no mortality or other effects were observed at 2000 mg substance per kg body weight.

Interpretation of results:
GHS criteria not met
Executive summary:

In a GLP-study according to OECD TG 423, Sprague-Dawley rats were administered 2000 mg test substance per kg body weight by gavage.

No mortality or other effects were observed until day 14.

According to the results of this study the GHS category of the substance is not classified in the absence of any relevant toxicological findings at the tested concentration and the LD50 value of the test substance is considered to be >2000 mg/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

Justification for classification or non-classification

In an experimental study under GLP conditions according to OECD Test Guideline 423 with rats, the LD50 value of the test substance is considered to be >2000 mg/kg bw.

Therefore, the substance is not classified for acute toxicity according to CLP-Regulation (EC) No 1272/2008.