Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 17 AUG 1999 to 07 SEP 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
22 MAR 1996
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
30 SEP 1996
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Batch: V.N0199.064
Expiry: 09.07.2001

Test animals

Species:
rat
Strain:
other: HanIbm: WIST (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, CH-4414 Füllinsdorf / Switzerland
- Age at study initiation: females 10 weeks, males 8 weeks
- Body weights at study initiation: females 161.7, 180.1, 181.1 g, males 223.9, 214.3, 218.8 g
- Fasting period before study: overnight 16-16.5 h
- Housing: groups of three in Makrolon type-4-cages with standard softwood bedding
- Diet: pelleted standard Kliba 3433, batch no. 39/99 rat maintainace diet, ad libitum
- Water: Community tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
PEG 300
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle (if gavage): 10 mL
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing on test day 1 (pre-administration), 8 and 15, observations four times during test day 1, once daily from day 2-15
- Necropsy of survivors performed: yes
- Other examinations performed: observation of changes in appearance and behaviour
Statistics:
No statistical analysis was done as no death occurred.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: exact LD50 not determinable due to absence of adverse toxic effect
Mortality:
No deaths occurred.
Clinical signs:
No clinical sign were observed.
Body weight:
Body weight was in the normal range of animals of this strain and age
Gross pathology:
No effects observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Single application of the limit dose of 2000 mg test substance per kg bw did not cause lethality in 3 male and 3 female HanIbm: WIST rats during the 14 day observation period, resulting in a LD50 > 2000 mg/kg bw.
Executive summary:

3 Male and 3 female rats (HanIbm: WIST) were subjected to test acute oral toxicity according to the acute class method (OECD TG 423, Limit test). The test substance was administered by gavage at the limit dose of 2000 mg/kg bw in polyethylene glycol. No animal died within the observation period, resulting in a LD50 > 2000mg/kg bw.