Registration Dossier

Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
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

Test material

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

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels
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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.