Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-10-24 to 1990-01-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted Feb 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
adopted Mar 1984
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 9 weeks (males), 11 weeks (females)
- Weight at study initiation: 192-209 g (males), 172-183 g (females)
- Fasting period before study: 12-18 h
- Housing: Groups of five animals in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet: Pelleted standard Kliba 343, Batch 55/89 rat maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum.
- Water: Community tap water, ad libitum
- Acclimation period: 1 week

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:
water
Remarks:
bi-distilled
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 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 and weighing:
Mortality/Viability: four times on Day 1 and daily thereafter until Day 15
Body Weights: on Day 1 (pre-administration), 8 and 15
Clinical Signs: four times during Day 1 and daily thereafter until Day 15
- Necropsy of survivors performed: yes

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 occurred up to the end of the 14-day observation period.
Clinical signs:
Hunched posture was observed in one male on Day 1 after treatment. Ruffled fur was observed in 3 males between Day 1 and 6 and in 2 females between Day 1 and 3. No clinical signs were observed in males and females from Day 7 and 4, respectively, until the end of the study.
Body weight:
The body weight gain of the animals was not affected by the test article treatment throughout the entire study period.
Gross pathology:
Macroscopical findings were limited to one male animal showing pale discolouration of the lungs and clay-coloured left lateral lobe of the liver. No abnormalities were observed in the remaining males and in any females.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 in male and female Wistar rats was determined to be greater than 2000 mg/kg bw. There were no treatment-related deaths and no abnormal changes in body weight. Clinical signs (hunched posture and ruffled fur) were observed in a few males and were fully reversible by study Day 7. Macroscopical findings (pale discolouration of the lungs and clay-coloured left lateral lobe of the liver) were limited to one male animal.
Based on the study results, the substance does not fulfil the criteria for classification in accordance with Regulation (EC) 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), and is thus considered to be not acutely toxic by the oral route.