Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(Z)-[(octadec-9-enyloxy)methyl]oxirane
EC Number:
262-268-7
EC Name:
(Z)-[(octadec-9-enyloxy)methyl]oxirane
Cas Number:
60501-41-9
Molecular formula:
C21H40O2
IUPAC Name:
2-[(octadec-9-en-1-yloxy)methyl]oxirane
Details on test material:
- Name of test material (as cited in study report): Cremophor verstufe
- Lot/batch No.: 58

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: DR. K. Thomae GMBH, D-7950 Biberach, FRG
- Weight at study initiation: males 181 g and females 192
- Fasting period before study: food depreviation 16 hours before test substance administration (water was available ad libitum).
- Housing: Five animals per stainless steel wire mesh cages, DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba labordiaet 343, Klingentalmuehle AG CH-4303 Kaiseraugst, Switzerland, ad libitum.
- Water: tap water, ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes: fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 40 g/100 mL
- Justification for choice of vehicle: test substance is insoluble in water.

MAXIMUM DOSE VOLUME APPLIED:
5 mL/kg
Doses:
2000 mg/kg
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: Recording of signs and symptoms several times on the day of test substance administration (at least once each workday). Check for moribund and dead animals twice each workday and once on public holidays.
- Necropsy of survivors performed: yes, sacrifice with CO2; then necropsy with gross-pathological examination. Necropsy of all animals that die as soon as possible.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed.
Clinical signs:
No abnormalities observed.
Body weight:
Males: 181 g at study start, 279 g after 13 days
Females: 192 g at study start, 238 g after 13 days
Gross pathology:
No pathological findings noted.

Applicant's summary and conclusion