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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 305-795-0 | CAS number: 95009-65-7
- 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)
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
Additional information
An oral repeated dose/reproductive/developmental screening study conducted with rosin, fumarated was identified; however, no repeated dose toxicity studies were identified for other category substances. Instead, several oral repeated dose/reproductive/developmental screening studies were identified for a rosin adduct ester and a gum rosin were used for read-across purposes because these substances are similar based on their structure and synthetic grounds. All studies were GLP compliant and followed OECD (422 or 421) guidelines. Summaries of the findings are presented below.
Rosin, fumarated was administered in the diet to rats at concentrations of 0, 1000 ppm (males 72-89 mg/kg bw/d; females 79-108 mg/kg bw/d), 3000 ppm (males 221-288 mg/kg bw/d; females 196-292 mg/kg bw/d), and 10,000 ppm (males 651-889 mg/kg bw/d; females 449-995 mg/kg bw/d) (Inveresk Research, 2004). The males were treated for 2 weeks prior to mating, through until necropsy after 4 weeks of treatment. The females were treated for 2 weeks prior to mating, then through mating, gestation and until termination on at least Day 4 of lactation. At 10,000 ppm there was a slight decrease in the mean number of implant sites per pregnancy and a consequent slight reduction in litter size at birth. The slight reduction in litter size between Day1-4 of lactation at 3000 ppm reflects the loss of most pups in one litter. As there were no effects of treatment on litter survival at 10,000 ppm the findings at this level are considered to be incidental. Based on these results, the NOEL for reproductive parameters was considered to be 3000 ppm (males 221-288 mg/kg bw/d; females 196-268 mg/kg bw/d).
Results for the supportingrepeated dose/reproductive/developmental screening studies are presented below:
In a reproductive/developmental toxicity screening study, 10 rats/sex/group were exposed to Gum Rosin at dose concentrations of 0, 1000, 3000, or 10000 ppm for 41-45 days (females) or 30 days (males) in the diet (Inveresk Research, 2003a). Treatment with Gum Rosin at 10000 ppm was associated with reduced weight gain/weight loss and reduced food consumption in the parental generation and a slight decrease in the mean number of implantation sites resulting in a subsequent slight reduction in litter size. Body weight gain reductions were also observed in males exposed to 3000 ppm Gum Rosin. Adverse effects in the F1 pups were limited to slightly reduced litter and pup weights. Based on the results of the present study, the no-observed-effect-level (NOEL) for reproductive/developmental toxicity in Sprague-Dawley rats was considered to be 3000 ppm for males and females and the NOEL for subchronic toxicity was considered to be 1000 ppm in males and 3000 ppm in females based upon reduced feed consumption and lower weight gain in animals consuming higher dietary concentrations of the test material.
In a reproductive/developmental toxicity screening study, 10 rats/sex/group were exposed ad libitum in the diet to rosin pentaerythritol ester (resin acids and rosin acids, esters with pentaerythritol) at dose concentrations of 0, 1000, 5000, or 20000 ppm for 57-60 days (females) or 28 days (males) (Inveresk Research, 2003b). There were no test substance-related effects on reproductive performance of the parental females or on survival and development of the F1 pups. All findings occurred in a non dose-dependent manner, were spurious in nature, or were biologically irrelevant and were not considered related to rosin pentaerythritol ester consumption. The no-observed-adverse-effect-level (NOAEL) for reproductive/developmental toxicity in Sprague-Dawley rats was considered to be 20000 ppm for males and females.
Based on these results, it would be premature to propose a 2-generation reproductive test at this time. The available information will be re-examined once results are available from a pre-natal developmental toxicity test (OECD 414) on Rosin are available, and the scientific need to propose or waive a 2-generation reproductive toxicity test will be determined and communicated to ECHA.
Short description of key information:
One key screening reproductive/developmental was for identified for rosin, fumarated . Several read-across screening reproductive/developmental studies were identified as supporting studies. No reproductive effects were observed in any study.
Effects on developmental toxicity
Description of key information
One key screening reproductive/developmental was identified for rosin, fumarated . No developmental effects were observed.
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
Additional information
Rosin, fumarated was administered in the diet to rats at concentrations of 0, 1000 ppm (males 72-89 mg/kg bw/d; females 79-108 mg/kg bw/d), 3000 ppm (males 221-288 mg/kg bw/d; females 196-292 mg/kg bw/d), and 10,000 ppm (males 651-889 mg/kg bw/d; females 449-995 mg/kg bw/d) (Inveresk Research, 2004). The males were treated for 2 weeks prior to mating, through until necropsy after 4 weeks of treatment. The females were treated for 2 weeks prior to mating, then through mating, gestation and until termination on at least Day 4 of lactation. At 10,000 ppm there was a slight decrease in the mean number of implant sites per pregnancy and a consequent slight reduction in litter size at birth. The slight reduction in litter size between Day1-4 of lactation at 3000 ppm reflects the loss of most pups in one litter. As there were no effects of treatment on litter survival at 10,000 ppm the findings at this level are considered to be incidental. Based on these results, the NOEL was considered to be 3000 ppm (males 221-288 mg/kg bw/d; females 196-268 mg/kg bw/d).
A pre-natal developmental toxicity test (OECD 414) on rosin (CAS 8050-09-7), rosin and resin acids, esters with pentaerythritol (CAS 8050-26-8) and rosin and resin acids, fumarated (CAS 65997-04-8) has been proposed to complement this information
Justification for classification or non-classification
Not classified for reproductive or developmental toxicity according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 or UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Additional information
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)