2-ethylhexyl 12-hydroxyoctadecanoate

Toxicity to reproduction

Administrative data

Endpoint:

reproductive toxicity, other

Remarks:

reproductive toxicity embryo-/fetotoxicity

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

REPORTING FORMAT FOR THE CATEGORY APPROACH

1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
Cetyl esters is a constituent of a broader group of cosmetic ingredients, the alkyl esters, which consist ofthe reaction products of fatty acids and alcohols. The 237 alkyl esters being reviewed in a safety assessment by The Cosmetic Ingredient Review (CIR) Expert Panel (Panel).
The ingredients in this review are alkyl esters. The substance of interest (2-ethylhexyl 12-hydroxyoctadecanoate) is a member of the category group.
The members have the same functions, similar metabolic pathways and similar hazardous profile.

2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL)
Data considered in the CIR safety assessment of the group of substances were judged as reliabile and adequate for the purpose of the REACH registration and to fill the gap information.

(i) A clear substance characterisation is available: in the category definition (Fiume MM. et al., 2015) a description of the category members is available in the category members are listed in a table. A general chemical structure of the members is also provided. That means the chemical identity of chemicals is sufficiently clear for a meaningful assessment of the proposed read-across. where necessary, the degree of purity is reported.
(ii) description of the substances: a clear and unambiguous description of each member of the category is submitted (Name, CAS and/or EC number and chemical structure for the source substance and for the target)
(iii) similarity (characteristics in common between substances): the members of the category are alkyl esters. The core relationship between these ingredients is a carboxyl ester functional group flanked on both sides by extended alkyl chains.
structural differences: some of these alkyl chains are saturated and some are unsaturated, and some of the chains are straight and some branched.
(iv) The study that was reported for is considered as adequate and reliable for the purpose of the
prediction based on read-across: the study results are adequate for the purpose of classification and labelling and risk assessment.

Data source

Reference

Reference Type:

review article or handbook

Title:

Safety Assessment of Alkyl Esters as Used in Cosmetics

Author:

Fiume MM. et al.

Year:

2015

Bibliographic source:

Int J Toxicol. 2015; 34(2 Suppl): 5S-69S.

Materials and methods

Test guideline

Qualifier:

no guideline available

GLP compliance:

not specified

Remarks:

This experimental study was reviewed in The Cosmetic lngredient Review Expert Panel (Panel) which assess the safety of 237 alkyl esters for use in cosmetics. The year is referred to the publication of the assessment.

Test material

Test material information

Constituent 1

Reference substance name:

Isononyl 3,5,5 trimethylhexanoate

EC Number:

609-993-0

Cas Number:

42131-25-9

Molecular formula:

C18H36O2

IUPAC Name:

Isononyl 3,5,5 trimethylhexanoate

Test material form:

not specified

Details on test material:

- State of aggregation:
not specified
- Particle size distribution:
not specified
- Mass median aerodynamic diameter (MMAD):
not specified
- Geometric standard deviation (GSD):
not specified
- Shape of particles:
not specified
- Surface area of particles:
not specified
- Crystal structure:
not specified
- Coating:
not specified
- Surface properties:
not specified
- Density:
not specified
- Moisture content:
not specified
- Residual solvent:
not specified
- Activation:
not specified
- Stabilisation:
not specified
- Other: not specified

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
no data
- Expiration date of the lot/batch:
no data
- Purity test date:
no data

RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
not applicable
- Specific activity:
not applicable
- Locations of the label:
not applicable
- Expiration date of radiochemical substance:
not applicable

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
no data
- Stability under test conditions:
no data
- Solubility and stability of the test substance in the solvent/vehicle:
no data
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
no data

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
no data
- Preliminary purification step (if any):
no data
- Final dilution of a dissolved solid, stock liquid or gel:
no data
- Final preparation of a solid:
-

FORM AS APPLIED IN THE TEST (if different from that of starting material)
: no data

TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)
not applicable

OTHER SPECIFICS:
- measurement of pH, osmolality, and precipitate in the culture medium to which the test chemical is added:
no data
- other information: The Cosmetic lngredient Review Expert Panel (Panel) assessed the safety of 237 alkyl esters for use in cosmetics.

Test animals

Species:

rat

Strain:

not specified

Details on species / strain selection:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: not specified
- Females (if applicable) nulliparous and non-pregnant: [yes/no] not specified
- Age at study initiation: (P) x wks; (F1) x wks not specified
- Weight at study initiation: (P) Males: x-x g; Females: x-x g; (F1) Males: x-x g; Females: x-x g not specified
- Fasting period before study: not specified
- Housing: not specified
- Use of restrainers for preventing ingestion (if dermal): yes/no not specified
- Diet (e.g. ad libitum): not specified
- Water (e.g. ad libitum): not specified
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified
IN-LIFE DATES: From: To: not specified

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on exposure:

PREPARATION OF DOSING SOLUTIONS: not specified

DIET PREPARATION
- Rate of preparation of diet (frequency): not specified
- Mixing appropriate amounts with (Type of food): not specified
- Storage temperature of food: not specified

VEHICLE
- Justification for use and choice of vehicle (if other than water): not specified
- Concentration in vehicle: not specified
- Amount of vehicle (if gavage): not specified
- Lot/batch no. (if required): not specified
- Purity:not specified

Details on mating procedure:

not relevant

Analytical verification of doses or concentrations:

not specified

Details on analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

6-17 postcoitum

Frequency of treatment:

not specified

Details on study schedule:

not specified

Doses / concentrations

Dose / conc.:

300 mg/kg bw/day

No. of animals per sex per dose:

not specified

Control animals:

not specified

Details on study design:

not specified

Positive control:

not specified

Examinations

Parental animals: Observations and examinations:

not specified

Oestrous cyclicity (parental animals):

not specified

Sperm parameters (parental animals):

not specified

Litter observations:

not specified

Postmortem examinations (parental animals):

not specified

Postmortem examinations (offspring):

not specified

Statistics:

not specified

Reproductive indices:

not specified

Offspring viability indices:

not specified

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:

not specified

Dermal irritation (if dermal study):

not specified

Mortality:

not specified

Body weight and weight changes:

not specified

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

not specified

Clinical biochemistry findings:

not specified

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Immunological findings:

not specified

Organ weight findings including organ / body weight ratios:

not specified

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Other effects:

not specified

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:

not specified

Reproductive function: sperm measures:

not specified

Reproductive performance:

not specified

Details on results (P0)

not specified

Effect levels (P0)

Dose descriptor:

NOAEL

Effect level:

300 mg/kg bw/day

Based on:

not specified

Sex:

not specified

Basis for effect level:

other: embryo-/fetotoxicity

Applicant's summary and conclusion

Conclusions:

Not embryotoxic or fetotoxic in rats dosed by gavage with 300 mg/kg/d on days 6-17 postcoitum

Executive summary:

Not embryotoxic or fetotoxic in rats dosed by gavage with 300 mg/kg/d on days 6-17 postcoitum