Methyl 12-hydroxyoctadecanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl laurate

EC Number:

203-911-3

EC Name:

Methyl laurate

Cas Number:

111-82-0

Molecular formula:

C13H26O2

IUPAC Name:

methyl laurate

Test material form:

liquid

Details on test material:

Dodecanoic acid methyl ester [methyl laurate, CAS No. 111-82-0], manufactured by Tokyo Chemical Industry Co., Ltd., Lot. No. GD 01, content 99.2%, molecular weight 214.35, melting point 5 ° C., boiling point 141 ° C., specific gravity 0.8706 (20 ° C.). Colorless and transparent liquid

Specific details on test material used for the study:

Methyl Dodecanoate, purity 99.2%; lot/batch # GD01

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories Japan, Inc.
- Females (if applicable) nulliparous and non-pregnant: no
- Age at study initiation: 5 wk
- Weight at study initiation: 154 - 167 g for males and 130 - 141 g for females, at dosing
- Fasting period before study: yes; fasting period for 16 hrs before administration to 3 hrs after administration
- Housing: 5/cage, stainless steel mesh
- Diet (e.g. ad libitum): Ad libitum, solid feed MF manufactured by the Oriental Yeast Co., Ltd (Chuo-ku, Tokyo). Analysis of the contaminants in the feed and water were implemented by request of Oriental Yeast Co., Ltd to the Japan Food Product Analysis Center Foundation (Shibuya-ku, Tokyo).
- Water (e.g. ad libitum): ad libitum, tap water via automatic water supply nozzle.
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): 20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 40% w/v%
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:

MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg bw

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Statistics:

Verification was performed using statistical methods (not specified)

Results and discussion

Preliminary study:

Preliminary results in 3 animals per sex at 2000 mg/kg bw showed no lethality at this dose. This dose was used in the main study

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

0 of 10

Clinical signs:

Soft stool in males and females up to 3 h after administration.

Body weight:

All animals gained weight during the study.

Gross pathology:

No abnormalities observed during necropsies.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

An OECD 401 Acute Toxicity assay in rats was undertaken with the test material at a limit dose of 2000 mg/kg bw in corn oil by oral gavage. No deaths or adverse effects were observed in any animal within the 14 days of the study. The substance is not classified for acute oral toxicity effects.