Registration Dossier

Administrative data

Description of key information

Acute oral toxicity in rats: 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:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From July 20 to August 21, 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Complete read-across justification is attached in section 13. Source study has reliability 1.
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
1996
Deviations:
yes
Remarks:
no overnight fasting prior dosing based on Swiss Tierschutzkommission.
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
1996
Deviations:
yes
Remarks:
no overnight fasting prior dosing based on Swiss Tierschutzkommission.
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
other: Hanlbm: WIST (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Biotechnology & animal breeding division, Wölferstrasse 4, CH 4414 Füllinsdorf, Switzerland
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: males 239.7 - 249.7 g; females 175.5 - 188.3 g
- Housing: groups of 3 in Makrolon type-4 cages with standard softwood bedding
- Diet: ad libitum
- Water: ad libitum
- Fasting period before study: 1 h
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 22 - 23.5 °C
- Humidity: 39 - 61 %
- Air changes: 10 - 15 per h
- Photoperiod: 12 h artificial fluorescent light, 12 h dark cycle
Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
VEHICLE
- Amount of vehicle in gavage: 10 ml
- Lot/batch no. (if required): 405374/1 30600


MAXIMUM DOSE VOLUME APPLIED: 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 observation for mortality: once daily during acclimatisation period, 1, 2, 3 and 5 h after test item administration on test day 1 and twice daily during days 2 - 15.
- Frequency of observation body weights: on test day 1 (pre-administration), 8 and 15
- Frequency of observation for clinical signs: each animal was examined for changes in appearance and behaviour once daily during acclimatisation period, 1, 2, 3 and 5 h after test item administration and once daily during days 2 - 15.
- Necropsy of survivors performed: yes
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths.
Clinical signs:
No clinical signs.
Body weight:
Body weight of animals was withn the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings at necropsy.

Body weight in g

dose level (mg/kg) animal no. group mean body weights
day of treatment day 8 day 15
2000 (F) 1 175.5 184.7 191.2
2 188.3 196.5 203.2
3 178.2 185.8 197.7
2000 (M) 4 239.7 262.9 286.0
5 240.4 148.4 273.5
6 249.7 166.3 287.4
Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
LD50 (rat) > 2000 mg/kg bw.
Executive summary:

Method

Acute toxicity by oral route based on acute toxic class method, according to OECD 423. The study was carried out as limit test. A dose of 2000 mg/kg bw was adminstered by gavage to 3 animal/sex using PEG 300 as vehicle. Animals were observed up to 14 days after dosing.

Results

No deaths occurred, thus an LD50 > 2000 mg/kg was established. Body weight gains during the study period were normal.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

 

The oral LD50 value was established to be greater than 2000 mg/kg bw, therefore the test substance is above the classification threshold for acute oral toxicity (Category 4: 300 < ATE ≤ 2000 mg/kg).