Squalene-rich fraction obtained from vegetable oil deodorizer distillate by transesterification, crystallisation and vacuum distillation

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

July 1984 to December 1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18 and C18-unsatd.

EC Number:

266-932-7

EC Name:

Fatty acids, C16-18 and C18-unsatd.

Cas Number:

67701-08-0

Molecular formula:

Not available for this UVCB

IUPAC Name:

C16-18 and C18-unsatd. fatty acyl

Test material form:

other: Clear yellow liquid

Details on test material:

- Name of test material (as cited in study report): Edenor Ti 05
- Physical state: Clear yellow liquid

Test animals

Species:

rat

Strain:

other: TNO Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann GmbH, Lage, Germany
- Weight at study initiation:
* Males: 170 d on Day -1, 159 g on day of administration
* Females: 151 g on Day -1, 141 g on day of administration
- Fasting period before study: From 16 h pre-dose to 3 h post-dose
- Housing: Macrolon Type 3 cages
- Diet (e.g. ad libitum): Altromin-Haltungsdiät 1324, Fa. Altromin GmbH, 4937 Lage, Germany
- Water (e.g. ad libitum): tap water
- Acclimation period: 6 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 21°C
- Humidity (%): ca. 51%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Doses:

5,000 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 d
- Frequency of observations and weighing: Mortality and clinical signs: sevaral times on the day of administration, twice daily after that; bodyweight once pre-dose, once on day of adminsitration, then after 48 h, 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic observation of organs

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

Rough fur in males and females 10 min to 1 h after dosing.
No other symptoms.

Body weight:

- Bodyweight gain in males: 67 g at Day 14 post-application
- Bodyweight gain in females: 26 g at Day 14 post-application

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the LD50 of the constituent in rats was determined to be greater than 5,000 mg/kg bw.

Executive summary:

A study was conducted to determine the acute oral toxicity of the constituent 'fatty acids, C16 -18 and C18 -unsatd.' to rats, according to EU Method B1. No treatment-related effects were noted at 5,000 mg/kg bw. Under the conditions of the study, the LD50 of the constituent in rats was therefore considered to be >5,000 mg/kg (Potokar, 1984).