Tetradecyl laurate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given. The analytical purity of the substance in the test product was not reported. Instead, it was based upon the estimated ranges for the product derived from the production recipe.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

the analytical purity of the test substance is not reported

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetradecyl laurate

EC Number:

244-966-3

EC Name:

Tetradecyl laurate

Cas Number:

22412-97-1

Molecular formula:

C26H52O2

IUPAC Name:

tetradecyl laurate

Constituent 2

Reference substance name:

Tetradecyl myristate

EC Number:

221-787-9

EC Name:

Tetradecyl myristate

Cas Number:

3234-85-3

Molecular formula:

C28H56O2

IUPAC Name:

tetradecyl myristate

Constituent 3

Reference substance name:

112-72-1

Cas Number:

112-72-1

IUPAC Name:

112-72-1

Details on test material:

- Name of test material (as cited in study report): Ceraphyl 424
- Analytical purity: mixture of tetradecyl myristate, tetradecyl laurate and tetradecanol (approx. 60-30-10 %w/w)
- Received: November 13, 1975

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- 30 young albino rats, equal number of male and female rats
- Weight at study initiation: 200-300 g
- Fasting before study: yes, 24 h
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no information

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30%
- Amount of vehicle + substance: 2, 4, 6, 16, 20, 25, 32, 64 mL/kg

Doses:

0.7, 1.3, 2.0, 5.3, 6.7, 8.3, 10.7, 21 g/kg bw

No. of animals per sex per dose:

5 animals per dose, male or female, both sexes were equally distributed..

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- After dosage animals on the same dosage level were placed in a common cage with free access to food and water.
- The animals were observed daily for a two week period.
- No postmortem, or histopathology examinations were performed in this particular study.

Statistics:

LD50 calculation based on probit analysis.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

8 600 mg/kg bw

Based on:

test mat.

95% CL:

>= 7 670 - <= 9 600

Mortality:

Total dose Test material Animals Animals
exposed dead % mortality
20 6.7 5 0 0
25 8.3 5 2 40%
32 10.7 5 5 100%
64 21.3 5 5 100%

Clinical signs:

The animals dosed at 0.7-1.3 g/Kg: unkempt coats for 12-16 hours after dosing. At 2.7 g/Kg: sluggish and impaired locomotion and unkempt coats whch recovered within 48 hours. At 5.3 and 6.7 g/kg: Staggering gait and impaired locomotion accompanied with ruffled and unkempt coats. At higher doses: Loss of motor control and dirty unkempt coats were evident, coma prior to death.

Body weight:

No information available.

Gross pathology:

No information available.

Other findings:

No information available.

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