C10-14-alkyl-1-(ethenyloxy)-

Endpoint summary

Description of key information

The LLNA returned a negative result. Therefore this substance is not classified as a skin sensitiser.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in chemico

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

direct peptide reactivity assay (DPRA)

Positive control results:

Cinnamaldehyde

Key result

Run / experiment:

other: Cysteine and Lysine reactivity

Parameter:

other: Pepteide reactivity

Value:

0

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Interpretation of results:

study cannot be used for classification

Conclusions:

waiting for study to be completed

Reference 2

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 to 22 January 2019

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Kyoeisha Chemical Co. / Bx 7080101
- Expiration date of the lot/batch: 01 Aug 2019
- Purity test date:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature.
- Stability under test conditions: Stable
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:

FORM AS APPLIED IN THE TEST (if different from that of starting material)

Species:

mouse

Strain:

CBA:J

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Commercial laboratory animal breeder.
- Females nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: no data
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: 18.8 to 26.4g
- Housing: Solid floor polypropylene mice cages (size: 290 mm x 220 mm x 140 mm). Each cage is fitted with a top grill having provision for keeping rodent pellet feed and water bottles.
- Diet (e.g. ad libitum): Teklad Certified Global High Fiber Rat/Mice Feed manufactured by Envigo, USA, was provided
- Water (e.g. ad libitum): Each cage was supplied with a polypropylene water bottle (capacity 300 mL) with a stainless steel nozzle.
- Acclimation period: 07 days
- Indication of any skin lesions: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23 °C
- Humidity (%): 64 to 66%
- Air changes (per hr): Minimum 15 air changes/hour
- Photoperiod (hrs dark / hrs light): The photoperiod was 12 h artificial light and 12 h darkness, light hours being 06:00 – 18:00 h (photoperiod maintained through an automatic timer).
- IN-LIFE DATES: From: To:

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

5%; 25% and 50%.;

No. of animals per dose:

5

Details on study design:

PRE-SCREEN TESTS:
- Compound solubility: up to 75%
- Irritation: In the preliminary assay, no erythema was observed at the site of application at tested concentrations of 10% and 50% (v/v) C10-C14 alkyl ether in AOO. Very slight erythema (score of 1) was observed from days 3 to 5 at the site of application at tested concentrations of 75% (v/v) in AOO and 100% C10-C14 alkyl ether.
- Systemic toxicity: no data
- Ear thickness measurements: ear thickness increases were below 25% at 10% and 50% (v/v) C10-C14 alkyl ether in AOO, while an increase of ≥ 25% in ear thickness was observed at 75% (v/v) in AOO and 100% C10-C14 alkyl ether. Therefore, dose concentrations of 5%, 25%, and 50% (v/v) C10-C14 alkyl ether in AOO were evaluated in the main LLNA study.
- Erythema scores: none

MAIN STUDY

ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:
- Criteria used to consider a positive response: A Stimulation Index (SI) value of three or more (SI value of the treated group over the control group) indicates potential to cause skin sensitisation.

TREATMENT PREPARATION AND ADMINISTRATION:

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Positive control results:

25% v/v HCA in AOO gave a group mean DPM of 6697±622.89*
* = Significantly higher than control (p<=0.01)

Parameter:

SI

Value:

1.76

Test group / Remarks:

G2 5% v/v

Parameter:

SI

Value:

2.38

Test group / Remarks:

G3 25% v/v

Parameter:

SI

Value:

2.72

Test group / Remarks:

G4 50% v/v

The vehicle and all test concentratuion returned no erythema scores in a 5 day period.

Interpretation of results:

GHS criteria not met

Conclusions:

This substance returned no erythema scores and the stimulation index did not reach 3 or more. Therefore this substance is not classified as a skin sensitiser under the conditions of this study.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The LLNA returned a negative result. Therefore this substance is not classified as a skin sensitiser.