Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 211-103-7 | CAS number: 629-70-9
- 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
Endpoint summary
Administrative data
Description of key information
The test item is a waxy solid that is used in the neat state exclusively as a cosmetic ingredient under industrial conditions. No evidence of systemic toxicity or local effects has been reported in acute studies and long-term investigations involving vertebrate animals are not appropriate.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: oral
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral
The pure test item is used exclusively as a cosmetic ingredient and is handled at industrial sites where stringent risk mitigation measures are in place and oral exposure is not expected under normal operational conditions. As a result,and in line with the ECHA news alert ‘Clarity on interface between REACH and the Cosmetics Regulation’ of 27 October 2014, where registrants are permitted to perform animal testing to meet the human health information requirements of REACH only when there is a need to assess worker safety, investigation of repeated dose oral toxicity in vertebrate animals is contraindicated.
Inhalation
The test item is a waxy solid with a vapour pressure of 4.8E-03 Pa at 25°C, is used in the neat state exclusively as a cosmetic ingredient, and is handled at industrial sites where stringent risk mitigation measures are put in place as a matter of course. No evidence of corrosion/irritation or sensitisation has been reported. Based on evaluation of the life cycle of the substance it is concluded that inhalation exposure will be low and that the most likely route of exposure for workers will be the dermal route. As a result, and in line with the ECHA news alert ‘Clarity on interface between REACH and the Cosmetics Regulation’ of 27 October 2014, where registrants are permitted to perform animal testing to meet the human health information requirements of REACH only when there is a need to assess worker safety, investigation of repeated dose toxicity via the inhalation route is inappropriate.
Dermal
The neat test item is used exclusively as a cosmetic ingredient and, in the light of that fact, dermal administration would normally constitute the most appropriate route for testing in the absence of existing data. However, no evidence of systemic toxicity was noted when acute results for the test item were evaluated by the Cosmetic Ingredient Review Expert Panel (see Section 7.2.3) and the test material was applied to human subjects multiple times over an extended period without eliciting visible responses (0.1mL*density/body weight = 0.1ml*962mg/mL/70kg =1.37mg/kg). Further evidence that worker safety should not be considered a concern arises from the fact that the test item is handled at industrial sites where stringent risk mitigation measures are routinely incorporated into operational procedures. As a result, and in line with the ECHA news alert ‘Clarity on interface between REACH and the Cosmetics Regulation’ of 27 October 2014, where registrants are permitted to perform animal testing to meet the human health information requirements of REACH only when there is a need to assess worker safety, it is considered inappropriate to carry out further investigations involving vertebrate animals.
Justification for classification or non-classification
No evidence of systemic toxicity or local effects has been reported in acute studies, exposure of humans via the inhalation route is unlikely due to the physico-chemical properties of the substance, and long-term investigations involving vertebrate animals are not appropriate for a cosmetic ingredient that is used in the neat state only in an industrial setting. Supporting evidence for lack of systemic and local effects is available from a study in which dermal application of 50 % test material in petrolatum (equivalent to 45 % of the test item described in this dossier) did not elicit any response in 50 out of 53 human volunteers when applied to the same test site for 24 hours on four consecutive days for a period of three weeks. Classification under the terms of Regulation (EC) No 1272/2008 is therefore not required.
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.