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Diss Factsheets

Administrative data

Description of key information

An acute oral toxicity test was conducted.

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: JMAFF Notification No. 8147, Nov 2000
Deviations:
not specified
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: 8-9 weeks
- Weight at study initiation: Body weight variation did not exceed +/- 20% of the sex mean (mean bodyweights on Day 1; 186 and 191 g for Groups 1 and 2 both receiving 2000 mg/kg respectively).
- Fasting period before study: Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance.
- Housing: Group housing of 3 animals per cage in labelled Makrolon cages, containing sterilised sawdust as bedding material and paper as cage-enrichment.
- Diet (e.g. ad libitum): Free access to pelleted rodent diet, except overnight prior to dosing and 3-4 hours after dosing.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: At least 5 days before start of treatment under laboratory conditions.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24°C
- Humidity (%): 40-70%
- Air changes (per hr): At least 10 per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark cycle.

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
Oral gavage, using plastic feeding tubes.
Vehicle: Propylene glycol 400 (Merck, Darmstadt, Germany) (specific gravity 1.125)
Preparation: The formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level.
Adjustment was made for specific gravity of the vehicle. No correction was made for purity of the test substance.
Doses:
2000mg/kg body weight to two successive groups
No. of animals per sex per dose:
3 (6 in total, two successive doses)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Bodyweights - Days 1 (pre-administration), 8 and 15.
Clinical signs - At periodic intervals on the day of dosing (Day 1) and once daily thereafter until Day 15.

- Necropsy of survivors performed: Yes
- Other examinations performed: Macroscopic abnormalities
Statistics:
No statistical analysis was performed.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No unscheduled mortality occured
Clinical signs:
other: Hunched posture was noted for all animals between Days 1 and 3
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The oral LD50 value of the test substance in Sprague-Dawley rats was established to exceed 2000 mg/kg bw/day.

According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.


Justification for selection of acute toxicity – oral endpoint
According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.

Justification for classification or non-classification

The oral LD50 value of the test substance was established to exceed 2000 mg/kg bodyweight, and accordingly this substance is not classified under the CLP regulation (1272/2008/EC), as amended.