Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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.
Qualifier:
equivalent or similar to
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
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals 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
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.
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.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
8 600 mg/kg bw
Quality of whole database:
Klimisch code 2, pre-GLP studies with basic data on methods and results.

Additional information

The key study performed with a product containing both tetradecyl laurate and tetradecyl myristate resulted in an LD50 of 8.6 g/kg bw (8600 mg/kg bw). No mortality occurred at 6700 mg/kg bw. A supporting study with tetradecyl myristate confirmed that the LC50 is > 5000 mg/kg bw. Hence, tetradecyl laurate does not require classification or labeling according to the CLP regulation.


Justification for selection of acute toxicity – oral endpoint
Study performed with a product containing approximately 90% of tetradecyl myristate and laurate.

Justification for classification or non-classification

Sonce both studies included in the dossier confirm that the LC50 for fatty alkyl esters is > 5000 mg/kg bw, the substance is not classified for acute oral toxicity.