Cinnamyl formate

Endpoint summary

Description of key information

Cinnamyl formate when used as a test material to evaluate its skin sensitization potential by human maximization test in concentration 4% (2760 µg/cm2) in petrolatum .Cinnamyl formate when applied on 25 male human volunteer .

No skin reaction was observed after induction and challenge exposure. Cinnamyl formate can be considered as not sensitizing on human skin.

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 is from peer reviewed journals

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To evaluate skin sensitization potential of cinnamyl formate on 25 human male volunteers.

GLP compliance:

not specified

Type of study:

other: human maximization test

Justification for non-LLNA method:

Not specified

Specific details on test material used for the study:

Name of test material (IUPAC name): Cinnamyl formate
- Common name: 3-Phenylallyl formate
- Molecular formula: C10H10O2
- Molecular weight: 162.187 g/mol
- Smiles notation: c1(\C=C\COC=O)ccccc1
- InChl: 1S/C10H10O2/c11-9-12-8-4-7-10-5-2-1-3-6-10/h1-7,9H,8H2/b7-4+
- Substance type: Organic
-physical state- colourless to yellowish liquid

Species:

other: human

Sex:

male

Details on test animals and environmental conditions:

no data available

Route:

other: not specified

Vehicle:

petrolatum

Concentration / amount:

4% (2760 µg/cm2)

Day(s)/duration:

not specified

Adequacy of induction:

not specified

No.:

#1

Route:

other: Not specified

Vehicle:

petrolatum

Concentration / amount:

4% (2760 µg/cm2)

Day(s)/duration:

not specified

Adequacy of challenge:

not specified

No. of animals per dose:

25 male human volunteer

Details on study design:

No data available

Challenge controls:

not specified

Positive control substance(s):

not specified

Reading:

1st reading

Group:

test chemical

Dose level:

4% (2760 µg/cm2)

Total no. in group:

25

Clinical observations:

no skin reaction observed

Remarks on result:

no indication of skin sensitisation

Interpretation of results:

other: non skin sensitizing

Conclusions:

Cinnamyl formate when applied on 25 male human volunteer did not gave any skin reaction after induction and challenge exposure. Cinnamyl formate can be considered as not sensitizing on human skin.

Executive summary:

Cinnamylformate when used as a test material to evaluate its skin sensitization potential by human maximization test in concentration 4% (2760 µg/cm2) in petrolatum .Cinnamyl formate when applied on 25 male human volunteer .

It did not gave any skin reaction after induction and challenge exposure. Cinnamyl formate can be considered as not sensitizing on human skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Skin sensitization:

In different studies, Cinnamyl formate has been investigated for potential for dermal irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits along with human data for target chemical Cinnamyl formate and its structurally similar read across substance Benzyl formate (CAS: 104-57-4) and structurally and functionally similar read across substance Methyl cinnamate (103-26-4) . The predicted data using the OECD QSAR toolbox has also been compared with the experimental data.

Skin sensitization potential was evaluated by experimental study conducted by Food and Chemical Toxicology 45 (2007) S1–S23 and The Food Chemicals Codex (1972) for the target Cinnamyl formate when used as a test material to evaluate its skin sensitization potential by human maximization test in concentration 4% (2760 µg/cm2) in petrolatum .Cinnamyl formate when applied on 25 male human volunteer . It did not gave any skin reaction after induction and challenge exposure. Cinnamyl formate can be considered as not sensitizing on human skin.

The above experimental data was supported by prediction done by using Danish QSAR for the target

In the prediction done using the Danish (Q) SAR Database, the skin sensitization was estimated to be negative on guinea pig and human for Cinnamyl formate .Using Battery algorithm model of Danish QSAR, Allergic Contact Dermatitis for Cinnamyl formate (104 -65 -4) estimated to be not sensitizing when applied to human and guinea pig skin.

The above results are further supported by experimental study conducted by Food and Chemical Toxicology 50 (2012) S402–S406 forstructurally similar read across substance Benzyl formate (CAS: 104-57-4)

Benzyl formate was not sensitizing to guinea pigs in a modified Draize sensitization study. In the induction phase, a 0.625% concentration of benzyl formate was injected intradermally at four sites on 10 Hartley albino guinea pigs. On day 14, the guinea pigs were challenged with a 0.25% intradermal injection at one site and 20% topical concentration at a different site. Scoring was done 24 h later. In the absence of a sensitization reaction in the first challenge the induction and challenge procedures were repeated, but this time a confirmatory challenge with controls was included irrespective of any apparent sensitization reaction at the previous challenge. Benzyl formate showed no reaction when treated intradermally in induction treatment and intradermally and topically in challenge treatment . Benzyl formate is considered to be non skin sensitizing to guinea pig skin.

The above results are further supported by experimental study conducted by Food and Chemical Toxicology 45 (2007) S1–S23 forstructurally and functionally similar read across substance Methyl cinnamate (103-26-4) .

Methyl cinnamate was used as a test material to evaluate its skin sensitization potential by human maximization test in concentration 2% (1380 µg/cm2) in petrolatum .Methyl cinnamatewhen applied on 25 male human volunteer did not gave any skin reaction after induction and challenge exposure.Methyl cinnamatecan be considered as not sensitizing on human skin.

 Based on the available data for the target as well as it read across substances;and applying the weight of evidence approach, it can be concluded that Cinnamyl formate was not skin sensitizing . Itcan be classified under the category “Not Classified” as per CLP regulation.

 

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available data for the target as well as it read across substances;and applying the weight of evidence approach, it can be concluded that Cinnamyl formate was not skin sensitizing . Itcan be classified under the category “Not Classified” as per CLP regulation.