Registration Dossier

Administrative data

Description of key information

Acute oral toxicity (OECD TG 401): LD50 >2000 mg/kg bw

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:
February 2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Not in accordance with GLP conditions
Reference:
Composition 1
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-97633 Sulzfeld, Germany
- Age at start of adaptation: 35 days (males) and 44 days (females)
- Weight at study initiation: between 169 and 188 g

ENVIRONMENTAL CONDITIONS
- No data available
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
DOSE VOLUME APPLIED: 2.36 mL/kg bw
Doses:
2000 mg/kg bw
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: The animals were observed before and immediately, 5, 15, 30 and 60 minutes, as well as 3, 6 and 24 hours after application and thereafter at least once a day until all symptoms had subsided, thereafter each wordking day.
- Necropsy of survivors performed: yes, at the end of the observation period the animals were sacrificed, necropsied and subjected to examination for gross pathological changes.
- Body weights: Individual body weights were recorded immediately before treatment (day 1) and thereafter in weekly intervals up to the end of the study and, when necessary, at death.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality observed.
Clinical signs:
No toxic symptoms were noted.
Body weight:
No treatment related changes were recorded in the body weights of the animals during the study period.
Gross pathology:
No abnormalities observed.
Interpretation of results:
other: not classified
Remarks:
Criteria not met according to EU CLP 1272/2008 and its amendments.
Conclusions:
Under the conditions of this study, the acute oral LD50 for the substance in male and female rats was determined to be >2000 mg/kg bw. Based on this result, the test material does not need to be classified for acute oral toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC) and its amendments.
Executive summary:

In the acute oral toxicity study, performed according to OECD guideline 401, 10 rats (5 males and 5 females) were administered the substance at a dose level of 2000 mg/kg bw by oral administration. Under the test conditions the test animals revealed neither toxic symptoms nor mortality. No body weight or macroscopical abnormalities were detected. The acute oral LD50 for the substance in male and female rats was determined to be >2000 mg/kg bw. Based on this result, the test material does not need to be classified for acute oral toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC) and its amendments.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The acute oral toxicity result is of sufficient quality and adequate for this dossier.

Additional information

In the acute oral toxicity study, performed according to OECD guideline 401, 10 rats (5 males and 5 females) were administered the substance at a dose level of 2000 mg/kg bw by oral administration. Under the test conditions the test animals revealed neither toxic symptoms nor mortality. No body weight or macroscopical abnormalities were detected. The acute oral LD50 for the substance in male and female rats was determined to be >2000 mg/kg bw.

Justification for classification or non-classification

Based on the result from the acute oral toxicity study, the test material does not need to be classified for acute oral toxicity in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP) and its amendments.