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Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | CAS number: -
- 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)
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Robust summary of study published in official document submitted to US EPA. There the study was classified as Klimisch 1a. The study was GLP compliant and performed according to OECD guideline 421. As the robust study summary is taken from a secondary source the reliability was downgraded.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Details on test material:
- fatty acids, C18-unsaturated dimers
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Four groups of 10 male and 10 female Sprague-Dawley rats
Administration / exposure
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- Males were treated for at least 4 weeks overall, starting from 2 weeks prior to mating until termination; females were treated for 2 weeks prior to mating, then through mating until termination after Day 4 of lactation.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
200 ppm
Basis:
- Remarks:
- Doses / Concentrations:
2,000 ppm (appr. 180 mg/kg/day)
Basis:
- Remarks:
- Doses / Concentrations:
20,000 ppm (appr. 1,858 mg/kg/day)
Basis:
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
Examinations
- Parental animals: Observations and examinations:
- The animals were monitored for clinical signs, body weight, food consumption, mating and litter performance.
All animals were submitted for necropsy, which included weighing male reproductive organs. Histopathology was conducted on the epididymides and testes of all control and high dose males and on the ovaries of all control and high dose females.
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
The mean number of implants per pregnancy was higher in all the treated groups compared to controls. However, historical data shows that the findings in the treated groups were within background ranges for animals of this age and strain. Rather, it was considered most likely that the control value was at the lower end of the background range. There were no obvious effects of treatment on litter size, litter survival, or pup weights at any dose level and no abnormalities noted among pups.
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 180 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: slight decrease in weight gain and an increase in piloerection
- Dose descriptor:
- NOEL
- Effect level:
- 1 858 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: reproductive parameters
Results: F1 generation
Effect levels (F1)
- Remarks on result:
- not measured/tested
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the parental No Observed Effect Level (NOEL) of fatty acid, C18-unsaturated dimers in rats was considered to be 2,000 ppm (approximately 180 mg/kg/day) and for reproductive parameters the NOEL was considered to be 20,000 ppm (approximately 1,858 mg/kg/day).
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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