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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 hexadecyl lactate or C12 -C16 (even) lactates.

Ceraphyl®28 containing C16 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

Referenceopen allclose all

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: no GLP and limited data on method and results.
Qualifier:
no guideline followed
Principles of method if other than guideline:
The method used was based on scientifically accepted method.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Holtzman
Sex:
female
Details on test animals or test system and environmental conditions:
The text animal were maintained on the regular diet of fox blox and water during the observation period of 7 days.
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
A single dose of 5,10 and 20 ml /kg bw were administered intragastrically using a rigid stomach tube.
Doses:
5-20ml per kg bw of rat
No. of animals per sex per dose:
10
Control animals:
no
Sex:
female
Dose descriptor:
LD50
Effect level:
> 20 other: ml/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
none
Body weight:
no data
Gross pathology:
no data
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Did not produce any vissible toxic effect.
Executive summary:

The LD50 of the test material is more than 10 times than the maximum limit for classification of 2000 mg/kg bw.The results show that even at highest dose of 20ml/kg bw, no vissible toxic effect was seen.

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:
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 7 days following administration.
Statistics:
The LD50 was calculated according to the method of Miller and Tainter (Proc. Soc. Biol. Med. 57, 261, 1944)
Key result
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:
No details.
Body weight:
Rats were weighing between 200-300 grams, no effects recorded on body weights.
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 31 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 study available

Additional information

The study used for acute toxicity was based on weight of evidence because of very limited data on methods and results. The study of oral acute toxicity covers that of inhalation and dermal acute toxicity according to Annex 7 of REACH-Legistration.

Justification for classification or non-classification

The test material was not classified. This was because the acute toxicity estimates (ATEs) which was assigned based on lethality exceed the upper limits for classification as satated in Guiadance on the application of the GLP criteria.