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Registration Dossier
Diss Factsheets
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EC number: 220-292-5 | CAS number: 2705-87-5
- 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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study planned
- Study period:
- The study will be performed depending on ECHA decision.
- Justification for type of information:
- NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: allyl 3-cyclohexylpropanoate
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
- Available GLP studies
There are no GLP studies available for this substance covering the endpoint of prenatal developmental toxicity
- Available non-GLP studies
There are no non-GLP studies available for this substance covering the endpoint of prenatal developmental toxicity
- Historical human/control data
There are no human/control data covering the endpoint of prenatal developmental toxicity
- (Q)SAR:
(Q)SAR approaches are currently not well fitted-for-purpose for reproductive toxicity and consequently no firm recommendations can be made concerning their routine use in a testing strategy in this area (ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R 7a: Endpoint specific guidance, 2017).
- In vitro methods:
There are no in vitro methods available to cover the endpoint of prenatal developmental toxicity.
- Weight of evidence:
There is no data available which is sufficient for a weight of evidence approach.
- Grouping and read-across:
There are no substances with sufficient data which apply for read across addressing prenatal developmental toxicity.
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
The substance is fully registered according to REACH Annex IX. Therefore, a study on developmental toxicity in one species is legally required. Furthermore, none of the adaption options from Annex IX, 8.7, column 2 are applicable for the substance, as the substance is not a genotoxic carcinogen, germ cell mutagen or known to cause developmental toxicity and is therefore classified as a reproductive toxicant Category 1 or 2 according to CLP. The test substance must be considered for developmental toxicity testing as due to human exposure according to its intended use, it can be absorbed systemically after oral exposure.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
Details on study design / methodology proposed:
Based on the legal requirements, a Prenatal Developmental Toxicity Study on a second species according to OECD guideline 414 is proposed to assess the effects of the test substance on growth, survival, maintenance of pregnancy of maternal animals and effects on resorptions, fetal deaths fetal growth, morphological variations and malformations of the offsprings of a species other than the rat.
This study is the test system proposed in Annex X, 8.7, column 1 and in the ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R 7a: Endpoint specific guidance, 2017. Under consideration of the substance properties, it is regarded to be the appropriate test system to investigate the potential to induce developmental toxicity, i. e. substances or their metabolites (hydrolysis products) that become readily systemically available upon ingestion. Furthermore, historical control data are available for various tissues. The test substance is proposed to be administered orally by gavage to rabbits as the proposed non-rodent species according to OECD guideline 414. As no repeated dose toxicity data are available in rabbits, doses will be based on a dose range finding test which will be conducted prior to the main experiment. It is noted that the additional time period required for the dose range finding test should also be considered in setting the deadline for submission of data.
Based on the results of the dose range finding test and taken the OECD requirements into consideration, a maximum dose will be chosen as a maximum tolerated dose or, if no effects occur, as the maximum recommended dose of 1000 mg/kg bw/day. Two additional doses (separated by a factor of 2 to 4) are proposed. An appropriate vehicle will be selected in a solubility study together with the testing laboratory, also taking into account the compatibility with the species. Details will be defined in the study protocol.
A sufficient number of female rabbits per dose or control groups to reach a minimum of 20 animals with implantation sites at necropsy will be chosen and is proposed. The test chemical is intended to be administered daily to pregnant animals by gavage, at least from implantation to one day prior to the day of scheduled killing. Shortly before caesarean section, the females will be killed, the uterine contents are examined, and the fetuses are evaluated for fetal deaths, sex, body weight, AGD, soft tissue and skeletal changes. Dams will be observed during the treatment period, weighted, and examined post-mortem. These examinations will include macroscopical structural abnormalities, weight of thyroid glands and uteri, histopathological assessment of thyroid gland and uteri, number of corpora lutea and degree of resorption.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Test material
- Reference substance name:
- Allyl 3-cyclohexylpropionate
- EC Number:
- 220-292-5
- EC Name:
- Allyl 3-cyclohexylpropionate
- Cas Number:
- 2705-87-5
- Molecular formula:
- C12H20O2
- IUPAC Name:
- prop-2-en-1-yl 3-cyclohexylpropanoate
Constituent 1
Test animals
- Species:
- rat
Administration / exposure
- Route of administration:
- oral: gavage
Results and discussion
Applicant's summary and conclusion
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.

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