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Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well- documtented study report which meets basic scientific principles (analytical purity of test substance is not specified).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Principles of method if other than guideline:
The test samples are given at various concentrations by tail venapunction. Thereafter, the animals are observed for a 14 day period after which necropsies of survivors are carried out.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopropyl laurate
EC Number:
233-560-1
EC Name:
Isopropyl laurate
Cas Number:
10233-13-3
Molecular formula:
C15H30O2
IUPAC Name:
isopropyl laurate
Details on test material:
- Name of test material (as cited in study report): isopropyllaurate
- Physical state: clear, colorless liquid
- Analytical purity: not given

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: from Institute's colony
- Weight at study initiation: male - 98 - 186g; female - 78 - 134g
- Housing: in groups of five in screenbottomed stainless steel cages
- Diet: stock diet, ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 - 25°C
- Air changes (per hr): weel-ventilated room

Administration / exposure

Route of administration:
intravenous
Vehicle:
propylene glycol
Doses:
2.88, 3.46, 4.15, 4.98 mL/kg bw (of a 10% dilution)
(2470, 2970, 3560, 4270 mg/kg bw - calculated using density (0.857 g/cm3) from hapter 4.4)
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
0.405 mL/kg bw
Based on:
test mat.
95% CL:
0.36 - 0.436
Sex:
male/female
Dose descriptor:
LD50
Effect level:
347 mg/kg bw
Based on:
other: calculated using density (0.857 g/cm3)
Mortality:
2.88 mL/kg - no animals died
3.46 mL/kg - 3 male and 1 female animal died
4.15 mL/kg - 3 male and 4 female animals died
4.98 mL/kg - 4 male and 4 female aninamls died
Clinical signs:
within one minute of dosing the animals showed convulsive movement of the hind legs, this disappaered after 10 to 30 seconds, thereafter, most rats showed short moments of aimless running, followed by loss of consciousness. Unconsciouness was observed for all treated animals, some recovered within 2 to 5 minutes after dosing, others died in this period by asphyxia.
Gross pathology:
no treatment related gross alterations
Other findings:
- Other observations: convulsive movements immediately after dosing were also observed in rats given propylene glycol

Applicant's summary and conclusion