Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 639-566-4 | CAS number: 165184-98-5
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Based on the grouping approach including their toxicological profile (see § 7.1), studies on Cinnamaldehyde, its tautomer alcohol (Cinnamic alcohol) and their corresponding acid (cinnamic acid) were considered reliable to assess the developmental toxicity of HCA and justify the read-across approach. Study published in german langage and only english summary is available. This is a published study following a stablished screening protocol that makes it adequate as a preliminary developmental toxicity study. It contains sufficient details to regard it as reliable for use in hazard assessment in a weight of evidence approach.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- It follows a short-term in vivo screening test based on proposal by Chernoff and Kavlock: Chernoff and Kavlock. An in vivo teratology screen utilizing pregnant mice as desccribed in J. Toxicol Environ Health 10: 541-550, 1982. Pregnant mice were dosed from day 6 to day 13 on gestation and were then allowed to deliver litters. Then litter size, birth weight, and neonatal growth and survival to postnatal day 3 were recoreded as indices of potential developmental toxicity.
This is also address in: Hardin et al. Workshop on the Chernoff/Kavlock preliminary developmental toxicity test. Teratog Carcinog Mutagen 7, 119-27, 1987. - GLP compliance:
- not specified
- Limit test:
- no
Test material
- Details on test material:
- - Name of test material (as cited in study report):Cinnamaldehyde
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Charles River Breeding Laboratories
- Age at study initiation: 6-8weeks at receipt
- Weight at study initiation:no data
- Fasting period before study:no data
- Housing: singly housed in solid-bottom boxes
- Diet (e.g. ad libitum):ad libitum (BP Nutrition rat mouse breeder diet no. 3, Purina certified rodent chow)
- Water (e.g. ad libitum):ad libitum
- Acclimation period:3-5 days. Mice were received from vendor on gestation day 1-3, and on day 6 those judge unsuitable for the study were discarded
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%):no data
- Air changes (per hr):no data
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: To:no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Standard dosing volume was 10ml/kg. Volume was determined on the basis of body weights on day 6 of gestation.
- Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- Time-mated mice were received from the vendor on days 0-2 of gestation.
- Duration of treatment / exposure:
- From day 6-13 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- Total approximately 20 days:
Mice were allowed to deliver their pups. This was expected on day 18 of gestation. On postnatal day 3 dams and litter were discarded. On day 22 those that didn't deliver were killed.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1200 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 49 time-mated females to ensure at least 20 surviving pregnant mice at term. This was in consideration to the fact that it was expected that 10% of them would not survive and a pregnancy sucess of 50%.
- Control animals:
- other: corn oil
- Details on study design:
- - Dose selection rationale: A dose range finding study was conducted with 5 doses using ten virgin female mice per group. The LD10 predicted on the basis of this study was the single dose used.
- Rationale for animal assignment (if not random): random
- Other:
Examinations
- Maternal examinations:
- Body weights
CAGE SIDE OBSERVATIONS: Yes
- Time schedule:twice daily during treatment and once daily on gestation days 14-17
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: on gestation day 6, 17 and postnatal day 3
FOOD CONSUMPTION : No
WATER CONSUMPTION : No
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice only of those females that failed to deliver a litter by the presumed gestation day 22.
- Organs examined: uteri - Ovaries and uterine content:
- uteri of females that failed to deliver litter by presumed gestation day 22
- Fetal examinations:
- litter weight on post natal day 1 and 3
number of live and dead pups on postnatal day 1 and 3 - Statistics:
- 2-tail ANOVA for body weights on day 6 of gestation.
1-tail Fisher's exact test for proportion of pregnant animals delivering a viable litter (at least one liveborn pup) compared to control group.
2-tail Mann-Whitney U-test for mice that delivered viable litter: maternal body weight change from gestation day 6 to postnatal day 3, number of livborn pups per litter, percent neonatal survival to postnatal day 3, average pup weight at birth, average pup weight gain by postnatal day 3. - Indices:
- Liveborn per litter, percentage survival of litter.
- Historical control data:
- none
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No mortality was observed. There was no difference in body weight gain or number of viable litters compared to control group.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- >= 1 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOEL
- Effect level:
- >= 1 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
Liveborn per litter, percentage survival of litter, pup birth weight and pup weight gain were comparable in the cinnamaldehyde treated group and control group.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, the NOEL for maternal toxicity and the NOEL for developmental toxicity are 1200 mg/kg bw/day or higher cynnamaldehyde since no adverse effects were observed in mice.
- Executive summary:
This study is used in a read-across approach to extrapolate the toxicity to development for alpha-hexylcinnamaldehyde. In a preliminary developmental study testing 60 chemicals, a dose of 1200 mg/kg bw/day of cinnamaldehyde was administered once daily by gavage to mice from days 6 -13 of gestation. The selected dose represented the predicted maternal LD10. Dams were allowed to deliver their litter around day 18 of gestation. Maternal body weights were recorded on gestation days 6, 17 and day 3 postpartum. Number of live pups and weight of pups was recorded on postnatal days 1 and 3. Reproductive endpoints were maternal weight change, litter size, birth weight and neonatal growth and survival to postnatal day 3.
Cinnamaldehyde induced no effect on maternal survival, maternal bodyweight gain and viable litters. Neonatal response showed no difference on liveborn / litter and percentage survival. Birth weight and weight gain was were normal for all pups. Following the classification used by Chernoff and Kavlock, cynnamaldehyde was recorded in the group of those that had no effect. Results in this assay and conventional mouse teratology tests were concordant. Conventional data were available for 14 chemicals (ten teratogens, one fetotoxin, three non teratogen) of which 11 (nine teratogens, one fetotoxin and one non teratogen) produced evidence of developmental toxicity. Therefore, cynnamaldehyde was considered as low priority candidates for conventional testing on the basis of results.
Under the test conditions, no maternal toxicity and no development effect was observed at the highest dose tested. The No Observed Effect Level was higher than 1200 mg/kg bw/d for maternal toxicity and development toxicity in mice.
This study is considered as acceptable for the developmental toxicity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)
Iako ECHA većinu materijala na ovim stranicama osigurava na vašem jeziku, dio ove stranice samo je na engleskom. Dodatne informacije o politici višejezičnosti ECHA-e.
Dobro došli na stranice ECHA-e Ove stranice ne podržavaju potpuno Internet Explorer 7 (i njegove ranije inačice). Preuzmite noviju inačicu Internet Explorera.
Na ovom portalu koristimo kolačiće kako bismo vam osigurali najbolje iskustvo njegova pregledavanja.
Saznajte više o tome kako upotrebljavamo kolačiće.