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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Justification for selection of acute toxicity

– oral endpoint:
Key studies performed with products containing tetradecyl lactate or C12 -C16 (even) lactates.

Ceraphyl®50 containing C14 lactate, Ceraphyl®31 containing C12 -C16 (even) lactates and Ceraphyl®41 containing C12 -C15 lactates all have an oral LD50 of 20,000 mg/kg

- inhalation endpoint:

The inhalation LC50 of lactate esters is generally above 5000 mg/m3.

– dermal endpoint:
A combination of dodecyl and tridecyl lactates, linear and branched, proved to be non-toxic. Supporting test with other alkyl lactates confirm the low acute dermal toxicity of the product for registration.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is non-GLP, but well described except for ommissions in experimental conditions like temperature and humidity.
no guideline followed
Principles of method if other than guideline:
Thirty young adult rats were distributed into three dosage groups of each ten rats and exposed to various dosages of test material administered by intragastric intubation.
GLP compliance:
Test type:
standard acute method
Limit test:
other: Holtzman
Details on test animals or test system and environmental conditions:
Type: young adult albino rats
Housing: in mesh bottom cages and fasted 24 h prior to dosing
Route of administration:
oral: gavage
unchanged (no vehicle)
yelow liquid
Details on oral exposure:
No further details.
0.5, 10, 20 ml/kg bw.
No. of animals per sex per dose:
Control animals:
Details on study design:
The rats received food and water ad libitum after dosage and were observed daily for 14 days following administration.
The LD50 was calculated according to the method of Miller and Tainter (Proc. Soc. Biol. Med. 57, 261, 1944)
Dose descriptor:
Effect level:
> 20 mL/kg bw
Based on:
test mat.
Dosage Animals Number of deaths daily day 14
mL/kg dosed 1 2 3 4 5 6 7 8 9 10 11 12 13 14 % Mortality
2.5 5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
5.0 5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
10.0 5 0 0 0 1 0 0 0 0 0 0 0 0 0 0 20
20.0 5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
40.0 5 0 0 0 1 0 1 1 0 1 0 0 0 0 0 80

Clinical signs:
other: No details.
Gross pathology:
No details.
Other findings:
No details.
Interpretation of results:
practically nontoxic
Migrated information Criteria used for interpretation of results: EU
The LD50 of Ceraphyl 50 for rats is more than 10 times higher than the maximum limit for classification of 2000 mg/kg bw .
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
20 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Read across study with analogue alkyl lactates.

Additional information

Justification for classification or non-classification

The oral LD50 of tetradecyl 2-hydroxypropanoate (CAS# 1323-03-1 and EC# 215-350-1) for rats is more than 10 times higher than the maximum limit for classification of 2000 mg/kg bw. Also dermal exposure to alkyl lactates show no adverse effects above 2000 mg/kg bw. Thus, tetradecyl 2 -hydroxypropanoate is not classified.