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EC number: 203-093-8 | CAS number: 103-26-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: pre-guideline study but performed fulfilling basic scientific principles
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Modified Challenge with intradermal and occlusive application
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Route:
- intradermal
- Vehicle:
- other: water, Freund's Complete Adjuvant (FCA) and petrolatum
- Concentration / amount:
- Induction: 2 intradermal injections of 5% aqueous solution and 2 5%solutions in Freunds' Complete Adjuvant (each 0.1 ml) and 25% in petrolatum on day 8 occlusive for 2 days (total dose 20 mg intradermally plus 250 mg epicutaneously)
Challenge: On day 21 with 25% in petrolatum occlusive for 24 hours. - Route:
- epicutaneous, occlusive
- Vehicle:
- other: water, Freund's Complete Adjuvant (FCA) and petrolatum
- Concentration / amount:
- Induction: 2 intradermal injections of 5% aqueous solution and 2 5%solutions in Freunds' Complete Adjuvant (each 0.1 ml) and 25% in petrolatum on day 8 occlusive for 2 days (total dose 20 mg intradermally plus 250 mg epicutaneously)
Challenge: On day 21 with 25% in petrolatum occlusive for 24 hours. - No. of animals per dose:
- 5 animals
- Details on study design:
- On day 0, the animals were injected intradermally with 0.1 ml of a 5% solution of the compound, with 0.1 ml of a 5% emulsion of the compound in FCA and with 0.1 ml of FCA alone, each injection was given twice. In addition, on day 8 the compound, dissolved in petrolatum up to 25%, was applied to a clipped skin area of the neck and kept under occlusive bandage for 2 days (total dose 20 mg intraderzzally plus 250 mg epicutaneously).0n day 21, an occlusive patch test with the compound in petrolatum was applied to the flank for 24 hours and the reactions were read 24 and 48 hours after removing the patch.
- Positive control substance(s):
- no
- Reading:
- other: 1st (24h after challenge) and 2nd (48 after challenge) reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% solution
- No. with + reactions:
- 3
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: other: 1st (24h after challenge) and 2nd (48 after challenge) reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% solution. No with. + reactions: 3.0. Total no. in groups: 5.0.
- Reading:
- rechallenge
- Hours after challenge:
- 144
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 4
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 144.0. Group: test group. Dose level: 25%. No with. + reactions: 4.0. Total no. in groups: 5.0.
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The treatment with methyl cinnamate causes sensitization in about 60% (first and second reading) and 80% (rechallenge) of the guinea pigs in the Maximization test.
- Executive summary:
In this Maximization test (intradermal induction and occlusive challenge) 4 out of 5 animals showed positive reaction following rechallenge.
Thus, in this test methyl cinnamate is considered a skin sensitizer.
Reference
Authors conclusion: 60% of the animals show positive test reactions 24 h and 48 h after removing the occlusive challenge patch. Furthermore, epicutaneous tests one week later are positive in 4/5 of the guinea pigs.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Methyl cinnamate has been studied for skin sensitisation in multiple tests.
In the key study (Maximization test) the test article was intradermally and epicutaneously induced (deviation from guideline) and occlusively challenged showing positive reactions in 60% resp. 80% of test. Also, in this study rather high doses were applied (total dose 20 mg intradermally plus 250 mg epicutaneously). Nevertheless, the substance is considered sensitising in this test. This finding is supported by three more studies, performed by the same author, testing the substance in a Draize test model, an Open Epicutaneous test and a Freund's Complete Adjuvant test, all showing positive reaction when high doses were applied but also showing, that with 3% challenge concentration no sensitisation was observed.
Thus, in this array of sensitisation tests the Authors concluded that methyl cinnamate is a weak sensitizer.
A guinea pig sensitization test used as supportive study (RIFM, 1971b) was conducted on white male guinea pigs, weighing approximately 311–397 g. Methyl cinnamate was tested as a 0.1% suspension in 5% ethyl alcohol in distilled water. Induction consisted of ten intradermal injections made over a period of three and a half weeks. A 0.05 ml aliquot of methyl cinnamate was used for the first intradermal induction injection and a 0.1 ml aliquot of methyl cinnamate was used for the second - tenth intradermal injections. Following a ten-day rest period, an intradermal challenge injection with a 0.05 ml aliquot of a 0.1% suspension of methyl cinnamate in 5% ethyl alcohol in distilled water was administered. Reactions were read 24 h later. No sensitization reactions were produced.
The results from other reports (Hausen et al., 1995) supported the conclusion for negative sensitisation at low concentrations as above. Two separate modified FCATs were conducted in guinea pigs to evaluate sensitization to 10% methyl cinnamate in acetone. No sensitization effects were observed.
The absence of skin sensitisation potential through methyl cinnamate in low concentrations is also supported by a study where methyl cinnamate was applied to 25 volunteers (see IUCLID section 7.10.4) confirming no sensitisation potential. However, no information on the amount applied in this test is available.
Migrated from Short description of key information:
Skin sensitization was observed with test article based on the available data (60% at 1st and 2nd challenge resp. 80% sensitisation at re-challenge).
Justification for selection of skin sensitisation endpoint:
Available test (Maximization test) according to current OECD 406 guideline.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data, methyl cinnamate does require classification as a skin sensitizer. In the guinea pig maximisation test identified as the key study 60% of the animals showed a positive response after intradermal induction with 5% test substance. Therefore, the substance is classified as a Category 1B according to CLP (Regulation EC No.1272/2008) and as a skin sensitiser, R43, according to DSD (Directive 67/548/EEC). Data on respiratory sensitization are lacking..
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