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Administrative data

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

Referenceopen allclose all

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
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.