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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 May - 26 May 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with acceptable restrictions; analytical purity data on test item not given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted in 1987
Deviations:
yes
Remarks:
analytical purity of test material not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl palmitate
EC Number:
203-966-3
EC Name:
Methyl palmitate
Cas Number:
112-39-0
Molecular formula:
C17H34O2
IUPAC Name:
methyl palmitate
Details on test material:
- Name of test material (as cited in study report): Palmitinsäuremethylester
- Physical state: solid, pasty, white
- Analytical purity: not given
- Stability under test conditions: stable in arachidis oil, DAB 9
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann GmbH, Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 175 g (males), 164 g (females)
- Housing: groups of 5 animals per cage, in Makrolon Type 3 cages
- Fasting period before study: 16 h before until 3 h after dosing
- Diet: pelleted Altromin Maintainance diet 1314 (Altromin GmbH, 4937 Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): 43-75
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 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/clinical signs twice daily; body weight on day -1, 1, 2, 7 and 14
- Necropsy of survivors performed: yes, macroscopic examination of all external orifices and organs in the thoracic and visceral cavities.

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 occurred during the study period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Body weight:
No effect on body weight was noted.
Gross pathology:
Gross pathology revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified