Isooctadecanoic acid, monoester with glycerol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 Dec 1988 - 18 Jan 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study. Lack of details on test material.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted in 1987

Deviations:

yes

Remarks:

lack of details on test material

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isooctadecanoic acid, monoester with glycerol

EC Number:

266-124-4

EC Name:

Isooctadecanoic acid, monoester with glycerol

Cas Number:

66085-00-5

Molecular formula:

C21H42O4

IUPAC Name:

1,3-Dihydroxy-2-propanyl 16-methylheptadecanoate

Details on test material:

- Name of test material (as cited in study report): [trade name] glycerol mono-isostearate
- Physical state: light yellow, thick liquid
- Analytical purity: no data

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: IFFA CREDO (L'Arbresle, France)
- Age at study initiation: 2 months
- Weight at study initiation: 174.7 ± 3.2 g (males), 178.8 ± 4.0 g (females)
- Fasting period before study: 16 h
- Housing: 5 animals of the same sex in makrolon boxes (46.5 x 31 x 19 cm) whose floor was covered with soft wood sawdust (UAR 96360 Villemoison). The stainless steel wire cover was fitted with a feeding device and a 500 mL drinking bottle.
- Diet: UAR A04C, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: during the 3 h following administration, the animals were continuously observed for clinical signs of toxicity. Daily observations were made on the following 14 days. Symptoms were recorded for each sex. A mortality check was made at least twice a day.
All animals were individually weighed on Day 0 prior to administration as well as on Days 3, 4, 7 and 14 post-dose.
- 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 were recorded.

Clinical signs:

other: No sign evidencing any toxicity at the level of the central nervous system or neuro-vegetative system was reported.

Gross pathology:

The autopsies performed at the end of the trial did not reveal any lesion at the level of the organs examined.

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