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Description of key information

Skin sensitizing test was performed in 25 human at 4% concentration in petrolatum. The induction given on five alternate-days for 48hr on forearm under occlusion. Patch sites were pretreated for 24 h with 5% aqueous sodium lauryl sulfate (SLS) under occlusion before induction exposure.After 10 days rest period , challenge application given for 48hr having same concentration as induction exposure. Evalution done after 24hr. Challenge applications were preceded by 1-hour applications of 10% aqueous SLS under occlusion.No sensitization was observed in any human thereforecinnamyl propionate (103-56-0) was considered to be not sensitizing in human.

 

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data from peer reviewed journal
Qualifier:
equivalent or similar to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
The skin sensitization study of cinnamyl propionate was performed on human.
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
No data available
Specific details on test material used for the study:
Name of the test chemical:3-phenylprop-2-en-1-yl propionate, Cinnamyl propionate
Molecular Formula: C12H14O2
Molecular Weight: 190.241 g/mol
InChI: 1S/C12H14O2/c1-2-12(13)14-10-6-9-11-7-4-3-5-8-11/h3-9H,2,10H2,1H3/b9-6+
Substance Type: Organic
Physical State: Liquid
Species:
other: Human
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
No data available
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
4%
Day(s)/duration:
48hr
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
4%
Day(s)/duration:
48hr
No. of animals per dose:
25
Details on study design:
Details on study design
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5
- Exposure period:48hr
- Test groups:25
- Control group:00
- Site: Forearms
- Frequency of applications: five alternate-day
- Duration:10 days
- Concentrations:4%

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge:10days after last induction application
- Exposure period:48hr
- Test groups:25
- Control group:00
- Site: fresh site
- Concentrations:4%
- Evaluation (hr after challenge):24hr

Other: Patch sites were pretreated for 24 h with 5% aqueous sodium lauryl sulfate (SLS) under occlusion before induction exposure while Challenge applications were preceded by 1-hour applications of 10% aqueous SLS under
occlusion
Challenge controls:
No data available
Positive control substance(s):
not specified
Statistics:
No data available
Positive control results:
No data available
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
4%
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
No skin sensitization reaction was observed
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: not sensitizing
Conclusions:
The cinnamyl propionate (103-56-0) was considered to be as not sensitizing in human.
Executive summary:

Skin sensitizing test was performed in 25 human at 4% concentration in petrolatum.The induction given on five alternate-days for 48hr on forearm under occlusion. Patch sites were pretreated for 24 h with 5% aqueous sodium lauryl sulfate (SLS) under occlusion before induction exposure. After 10 days rest period, challenge application given for 48hr having same concentration as induction exposure. Evaluation done after 24hr. Challenge applications were preceded by 1-hour applications of 10% aqueous SLS under occlusion.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Skin sensitization 

In different studies, cinnamyl propionate (103-56-0) has been investigated for potential of skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in guinea pig and human for target chemical cinnamyl propionate (103-56-0) and its structurally similar read across substancesCinnamyl acetate(103-54-8)andEthyl cinnamate (103-36-6) the predicted data using the OECD QSAR toolbox has also been compared with the experimental data of read across.

The experimental study conducted by D.L.J. Opdyke(Food and Cosmetics Toxicology, Vol. 12, Pg. 859, 1974) to evaluate the skin sensitizing potential of cinnamyl propionate (103-56-0) in human. Skin sensitizing test was performed in 25 human at 4% concentration in petrolatum.The induction given on five alternate-days for 48hr on forearm under occlusion. Patch sites were pretreated for 24 h with 5% aqueous sodium lauryl sulfate (SLS) under occlusion before induction exposure. After 10 days rest period, challenge application given for 48hr having same concentration as induction exposure. Evaluation done after 24hr. Challenge applications were preceded by 1-hour applications of 10% aqueous SLS under occlusion.No sensitization was observed in any human therefore cinnamyl propionate (103-56-0) was considered to be not sensitizing in human.

The skin sensitization potential Cinnamyl propionate (103-56-0) was estimated by SSS (2017) using OECD QSAR toolbox v3.3 with log kow as the primary descriptor and considering the six closest read across substances Cinnamyl propionate (103-56-0) was predicted to be not sensitizing to the skin of female Dunkin-Hartley guinea pig.

Prediction done using the Danish (Q) SAR Database, the skin sensitization was estimated to be negative on guinea pig and human for3-phenylprop-2-en-1-yl propionate, Cinnamyl propionate. Using Battery algorithm model of Danish QSAR, Allergic Contact Dermatitis for 3-phenylprop-2-en-1-yl propionate, Cinnamyl propionate (103-56-0) estimated to be not sensitizing when applied to human and guinea pig skin.

Supported by experimental study conducted by D.L.J. Opdyke(Food and Cosmetics Toxicology. Vol. 11, Pg. 1063, 1973) to evaluate the skin sensitizing potential of read across substance Cinnamyl acetate(103-54-8) in human. Skin sensitizing test was performed in 25 human at 5% concentration in petrolatum.The induction given on five alternate-days for 48hr on forearm under occlusion. Patch sites were pretreated for 24 h with 5% aqueous sodium lauryl sulfate (SLS) under occlusion before induction exposure. After 10 days rest period, challenge application given for 48hr having same concentration as induction exposure. Evaluation done after 24hr. Challenge applications were preceded by 1-hour applications of 10% aqueous SLS under occlusion. No sensitization was observed in any human therefore Cinnamyl acetate(103-54-8) was considered to be not sensitizing when exposed to human.

Also it is further Supported by experimental study conducted by D.L.J. Opdyke(Food and Cosmetics Toxicology. Vol. 12, Pg. 721, 1974)to evaluate the skin sensitizing potential of read across substance Ethyl cinnamate (103-36-6) in human. Skin sensitizing test was performed in 25 human at 4% concentration in petrolatum.The induction given on five alternate-days for 48hr on forearm under occlusion. Patch sites were pretreated for 24 h with 5% aqueous sodium lauryl sulfate (SLS) under occlusion before induction exposure. After 10 days rest period , challenge application given for 48hr having same concentration as induction exposure. Evaluation done after 24hr. Challenge applications were preceded by 1-hour applications of 10% aqueous SLS under occlusion. No sensitization was observed in any human therefore Ethyl cinnamate (103-36-6) was considered to be not sensitizing when exposed to human.

 

Thus based on the above predictions on cinnamyl propionate (103-56-0) as well as its read across and applying weight of evidence, it can be concluded that cinnamyl propionate (103-56-0) is not a skin sensitizer. Thus comparing the above studies with the criteria of CLP regulation, cinnamyl propionate (103-56-0) can be considered as not classified for skin sensitization.

 

 

Justification for classification or non-classification

Thus comparing the above studies with the criteria of CLP regulation, cinnamyl propionate (103-56-0) can be considered as not classified for skin sensitization.

 

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