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Diss Factsheets
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EC number: 203-629-0 | CAS number: 108-91-8
- 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://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicity to reproduction
Administrative data
- Endpoint:
- reproductive toxicity, other
- Remarks:
- other: Reproduction/Embryotoxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- multigenertation but only one dose applied. The evaluation also of this study is restricted because of the inadequate documentation. Furthermore, the study design does not allow the evaluation of parental toxicity and only a single (very high) dose was applied, which leads to further limitation in evaluating the findings.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Long term toxicity and reproduction study (including a teratogenicity study) with cyclamate, saccharin and cyclohexylamine
- Author:
- Kroes R, Peters PWJ, Berkvens JM, Verschuuren HG, de Vries Th, van Esch GJ
- Year:
- 1 977
- Bibliographic source:
- Toxicology 8, 285-300 (1977)
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
- Principles of method if other than guideline:
- Method: multigeneration study : The P-generation started with 50 males and 50 females After an acclimisation period of 5 weeks 20 females were housed with 10 males to produce F1-generation, similar procedure to produce F2-, F3-, F4-, F5- and F6-generation.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 27817-50-1
- Cas Number:
- 27817-50-1
- IUPAC Name:
- 27817-50-1
- Details on test material:
- IUCLID4 Test substance: other TS: cyclohexylamine sulfate
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: (P) +/- 14 g
- Housing:
except for matimg males were housed individually,
pregnant females individually,
otherwise females in groups of 5
- Diet ad libitum
- Water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
-
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: mixed in diet
- Details on exposure:
- Mice were fed diets containing 0.5 % cyclohexylamine sulfate up to and including f6 generation
- Details on mating procedure:
- during mating period 2 females and 1 males were housed together
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Exposure period: multigeneration experiment up to and including F6-generation
- Frequency of treatment:
- daily in diet
- Details on study schedule:
- 20 females were housed with 10 males for the same group (2 females and 1 male in one cage) to produce a F1a generation. The F1a generation was killed after weaning because th litters were too small to produce further generations. Therefote 30 females were mated with 15 males of the same group which produced the F1 a generation.
Further generations were bred in a straight line. ´The breeding results were sufficient to use the a-litters for further reproduction. Therefore 20 females and 10 males of every new generation were aselectively chosen from all litters in each group
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.5 % in diet = ca. 600 mg/kg/day
Basis:
- Control animals:
- yes
- Details on study design:
- 20 females were housed with 10 males for the same group (2 females and 1 male in one cage) to produce a F1a generation. The F1a generation was killed after weaning because th litters were too small to produce further generations. Therefote 30 females were mated with 15 males of the same group which produced the F1 a generation.
- Positive control:
- no
Examinations
- Parental animals: Observations and examinations:
- pregnancy rate, live born fetuses, sex ratio
- Oestrous cyclicity (parental animals):
- no data
- Sperm parameters (parental animals):
- no data
- Litter observations:
- From the litters of the F2, F3 and F4 generation the number of implantation sitesm the number of living feuses , the number of resorptions verus the total number of implantations, the mean fetal weights was calculated
- Postmortem examinations (offspring):
- post natal survival day 5, day 20 and the respective pup weight
- Statistics:
- student's t-test, Chi-square test, Wilcoxon test
- Reproductive indices:
- no data
- Offspring viability indices:
- no data
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- dose level:
- Effect level:
- ca. 0.5 other: % in diet
- Based on:
- not specified
- Sex:
- male/female
- Basis for effect level:
- other: no data
- Remarks on result:
- other: Generation: mean over all generations (migrated information)
Results: F1 generation
Details on results (F1)
Effect levels (F1)
- Remarks on result:
- other: See details on results section
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
RS-Freetext:
Significant decrease in the number of implantation sites
and in the number of liveborn fetuses, increased perinatal
mortality and a significant reduction in weight gain of the
offspring were observed; no teratogenic effects were found.
The cyclohexylamine group shows a tendency to a delayed
ossification.
Breeding generations: growth retardation in the CHA group,
which was more pronounced in the first generations and
especially seen in the females. The growth inhibition was
already present at weaning.
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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