Tetradecyl lactate

Endpoint summary

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.

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.