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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 270-986-7 | CAS number: 68512-65-2
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to good scientific methodology and to the procedures and protocols as outlined in the Federal Register Vol. 46, No. 17 (January 27, 1981).
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- sensitisation data (humans)
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to good scientific methodology and to the procedures and protocols as outlined in the Federal Register Vol. 46, No. 17 (January 27, 1981).
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Qualifier:
- according to guideline
- Guideline:
- other: Study conducted according to the procedures and protocols outlined in the Federal Register Vol. 46, No. 17 (January 27,1981).
- Deviations:
- not specified
- GLP compliance:
- no
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- Two hundred twenty-two (222) subjects, male and female, ranging in age from 18 to 75 years, started the study; two hundred two (202) subjects completed this study. The twenty subjects who discontinued the study did so for reasons unrelated to the test substance.
- Clinical history:
- No data
- Controls:
- No
- Route of administration:
- dermal
- Details on study design:
- Subjects (n = 202) were exposed (skin on the back, under occlusion) three times a week for three weeks (Days 1, 3, and 5). The patches removed 24 hours later. Test sites were examined for irritation prior to application on Days 3, 5 and Day 1 of the following week. Following a 2 week rest period, subjects were challenged with the test substance on both the original site and a naïve site (volar forearm). The sites were evaluated at 24 and 48 hours post-application to assess sensitization potential.
- Results of examinations:
- No effects related to the test substance were observed for any individual either during the three week induction period or at challenge for sensitization during Week 6.
- Conclusions:
- Under conditions of this study, Resin acids and Rosin acids, hydrogenated, esters with glycerol (also known as Foral 85 (X-31733-28)) did not cause irritation and did not elicit evidence of skin sensitization in humans. The test substance presents a low skin sensitization hazard upon skin contact under conditions of normal use. Foral 85 (X-31733-28) is not classified for Skin Sensitization according to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
- Executive summary:
In a human repeat insult patch test, a group of 202 panelists (male and female) were exposed to 0.2 mL of Foral 85 (X-31733-28) under occluded patch. Induction applications were made for 24 hours, 3 times/week for a total of 10 applications. After each 24 hours of exposure, the patches were removed, and 48-72 hours after patch application, the sites were graded for irritation. After a rest period of 2 weeks following the last application, the panelists were patched with the test substance on both the original site and a naïve site (volar forearm) to determine the sensitization potential of the test material. No irritation was seen in any panelist during the induction or the sensitization (challenge) portions of the test. Under the conditions of the study, Foral 85 (X-31733-28) did not demonstrate a potential for dermal irritation and/or sensitization.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Study conducted according to the procedures and protocols outlined in the Federal Register Vol. 46, No. 17 (January 27,1981).
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Resin acids and Rosin acids, hydrogenated, esters with glycerol
- EC Number:
- 266-042-9
- EC Name:
- Resin acids and Rosin acids, hydrogenated, esters with glycerol
- Cas Number:
- 65997-13-9
- Details on test material:
- -Test material (as cited in report): X-31733-28
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- Two hundred twenty-two (222) subjects, male and female, ranging in age from 18 to 75 years, started the study; two hundred two (202) subjects completed this study. The twenty subjects who discontinued the study did so for reasons unrelated to the test substance.
- Clinical history:
- No data
- Controls:
- No
- Route of administration:
- dermal
- Details on study design:
- Subjects (n = 202) were exposed (skin on the back, under occlusion) three times a week for three weeks (Days 1, 3, and 5). The patches removed 24 hours later. Test sites were examined for irritation prior to application on Days 3, 5 and Day 1 of the following week. Following a 2 week rest period, subjects were challenged with the test substance on both the original site and a naïve site (volar forearm). The sites were evaluated at 24 and 48 hours post-application to assess sensitization potential.
Results and discussion
- Results of examinations:
- No effects related to the test substance were observed for any individual either during the three week induction period or at challenge for sensitization during Week 6.
Applicant's summary and conclusion
- Conclusions:
- Under conditions of this study, Resin acids and Rosin acids, hydrogenated, esters with glycerol (also known as Foral 85 (X-31733-28)) did not cause irritation and did not elicit evidence of skin sensitization in humans. The test substance presents a low skin sensitization hazard upon skin contact under conditions of normal use. Foral 85 (X-31733-28) is not classified for Skin Sensitization according to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
- Executive summary:
In a human repeat insult patch test, a group of 202 panelists (male and female) were exposed to 0.2 mL of Foral 85 (X-31733-28) under occluded patch. Induction applications were made for 24 hours, 3 times/week for a total of 10 applications. After each 24 hours of exposure, the patches were removed, and 48-72 hours after patch application, the sites were graded for irritation. After a rest period of 2 weeks following the last application, the panelists were patched with the test substance on both the original site and a naïve site (volar forearm) to determine the sensitization potential of the test material. No irritation was seen in any panelist during the induction or the sensitization (challenge) portions of the test. Under the conditions of the study, Foral 85 (X-31733-28) did not demonstrate a potential for dermal irritation and/or sensitization.
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.