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:
2001

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: semi-solid, wax-like (at 20°C)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS: rats, Wistar Crl:(WI) BR (outbred, SPF-Quality)
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: ca. 7 weeks
- Housing: group housing of 3 animals per sex per cage (Macrolon cages, type IV)
- Fasting period before study: up to 20h prior to dosing, 3-4h after administration of the test material
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: the vehicle was tested in a pre-test.
Doses:
single dose: 2000 mg/kg bw
No. of animals per sex per dose:
3 animals/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: twice daily (mortality//viability), at periodic intervals on Day 1 (administration) and thereafter once daily until Day 15 (clinical signs)
- Frequency of weighing: Days 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Statistics:
not performed

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured.
Clinical signs:
Lethargy, hunched posture, uncoordinated movements and/or piloerection were noted among the females on Day 1. No clinical signs of systemic toxicity were noted in males.
Body weight:
The mean body weight gain shown by the surviving animals over the study period was considered to be similar to that expexted of normal untreated animals of the same age and strain.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:
other: no acute lethal toxicity
Conclusions:
Based on the results and according to the EU REGULATION (EC) 1272/2008 the substance does not have to be classified for oral toxicity.