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Diss Factsheets
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EC number: 281-928-5 | CAS number: 84066-92-2
- 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)
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Remarks:
- COMET assay
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- COMET assay agreed as further study following ECHA discussions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
- Version / remarks:
- 2016
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian comet assay
Test material
- Reference substance name:
- Schiff bases, C11-14-tert-alkyl methylene
- EC Number:
- 271-766-3
- EC Name:
- Schiff bases, C11-14-tert-alkyl methylene
- Cas Number:
- 68607-67-0
- Molecular formula:
- C14H29N
- IUPAC Name:
- Schiff bases, C11-14-tert-alkyl methylen
- Test material form:
- liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Identification: Formaldehyde, reaction products with ethylenediamine
CAS Number: 84066-92-2
Physical state/Appearance: Clear colorless liquid
Batch: LC-354-124
Purity: 93% (water 65.6%), ie ca 35%
Expiry Date: 01 January 2019
Storage Conditions: Room temperature in the dark
Intended use/Application: Hydrogen sulphide scavenger
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- Wistar Han™ (HsdRCCHan™WIST)
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- The animals were housed in groups of up to five in solid-floor polypropylene cages with woodflake bedding. Free access to mains drinking water and food (Envigo Teklad 2014 Rodent Pelleted Diet) was allowed throughout the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Water
- Details on exposure:
- Double dose of maximum 660 mg/kg and killed 4 hours after second dose.
- Duration of treatment / exposure:
- Two doses,
Sampling 4 hours after second dose - Frequency of treatment:
- All animals were dosed twice 24 hours apart
- Post exposure period:
- 4 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 165 mg/kg bw/day (nominal)
- Dose / conc.:
- 330 mg/kg bw/day (nominal)
- Dose / conc.:
- 660 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Seven
- Control animals:
- yes, concurrent vehicle
- other: Positive control group
- Positive control(s):
- N-Nitroso-N-methylurea (MNU)
Examinations
- Tissues and cell types examined:
- Samples of liver, glandular stomach, duodenum and gonadal somatic cells (testes) were obtained from each animal.
Bone marrow was also sampled from the animals of the vehicle control group and the MTD dose group for slide preparation. - Details of tissue and slide preparation:
- Sub-samples of the liver, glandular stomach, duodenum and gonadal somatic cells (testes) were taken from the vehicle control animals and the dose group animals and preserved in 10% buffered formalin for possible histopathology investigations. Assessment of cytotoxicity by histopathology is conducted if the results from the Comet assay, or other observations, suggest cytotoxicity may be confounding the interpretation of the Comet assay.
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In the range finding test, there was one death at 880 mg/kg, so the top dose of 660 mg/kg was used with hunched posture, lethargy, ataxia, ptosis and pilo-erection with significant weight loss between the start of the test and its death. Necropsy revealed hemorrhaging along the limiting ridge of the stomach.
Applicant's summary and conclusion
- Conclusions:
- The test item, Formaldehyde, reaction products with ethylenediamine did not induce any increases in the percentage (comet) tail intensity or median percentage tail intensity in the liver, glandular stomach, duodenum or gonadal somatic cells (testes) and therefore the test item was considered to be unable to induce DNA strand breakage to these tissues in vivo, under the conditions of the test.
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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