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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
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1964
Reliability:
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.
Qualifier:
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:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Holtzman
Sex:
female
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
Vehicle:
unchanged (no vehicle)
Remarks:
yelow liquid
Details on oral exposure:
No further details.
Doses:
0.5, 10, 20 ml/kg bw.
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
The rats received food and water ad libitum after dosage and were observed daily for 14 days following administration.
Statistics:
The LD50 was calculated according to the method of Miller and Tainter (Proc. Soc. Biol. Med. 57, 261, 1944)
Sex:
female
Dose descriptor:
LD50
Effect level:
> 20 mL/kg bw
Based on:
test mat.
Mortality:
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
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
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:
LD50
Value:
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.