Fatty acids, C16-18 (even numbered), aluminum salts

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented publication which meets basic scientific principles.

Data source

Reference

Reference Type:

publication

Title:

Oral toxicities of lauric acid and lauric acid derivates

Author:

Fitzhugh O.G. et al.,

Year:

1960

Bibliographic source:

Toxicol Appl Pharmacol. 2:59-67

Materials and methods

Principles of method if other than guideline:

Feeding study, with lauric acid given at a concentration of 10% in the diet to 5 male rats for a study period of 18 weeks.

GLP compliance:

no

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lauric acid

EC Number:

205-582-1

EC Name:

Lauric acid

Cas Number:

143-07-7

IUPAC Name:

lauric acid

Details on test material:

- Name of test material (as cited in study report): lauric acid
- Analytical purity: no data

Test animals

Species:

rat

Strain:

Osborne-Mendel

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 40-50 g
- Housing: animals were housed individually
- Diet: basal diet of ground commercial biscuit, ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

DIET PREPARATION
- Rate of preparation of diet (frequency): every two weeks

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

18 weeks

Frequency of treatment:

available by feed

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
10%
Basis:
nominal in diet

Doses / concentrations 2

Remarks:

Doses / Concentrations:
ca. 5000 mg/kg bw/day
Basis:
other: calculated assuming an average daily food consumption of 5 g/100 g bw (WHO, 1987)

No. of animals per sex per dose:

5

Control animals:

yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes

DETAILED CLINICAL OBSERVATIONS: Yes

BODY WEIGHT: Yes
- Time schedule for examinations: weekly

HAEMATOLOGY: Yes
- Time schedule for collection of blood: at the end of the study period (no further details)
- How many animals: 5

Sacrifice and pathology:

GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: No

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

not specified

Clinical biochemistry findings:

not specified

Urinalysis findings:

not examined

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

not examined

Histopathological findings: neoplastic:

not examined

Details on results:

CLINICAL SIGNS AND MORTALITY
No mortality and no clinical signs of toxicity were noted during the study period.

BODY WEIGHT AND WEIGHT GAIN
No effects on body weight were noted during the study period.

ORGAN WEIGHTS
No significant differences in organ weight between the control and test animals were noted.

GROSS PATHOLOGY
During necropsy no differences between the control and test animals were noted.

Effect levels

1

Dose descriptor:

NOAEL

Effect level:

>= 10 other: % in diet

Based on:

test mat.

Sex:

male

Basis for effect level:

other: overall effects

2

Dose descriptor:

NOAEL

Effect level:

>= 5 000 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male

Basis for effect level:

other: overall effects

Target system / organ toxicity

Critical effects observed:

not specified