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EC number: 606-441-0 | CAS number: 201305-16-0
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1992)
- Deviations:
- yes
- Remarks:
- (study report with limited information; rechallenge was conducted sytemically)
- GLP compliance:
- no
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A valid Buehler test was available before REACh came into force, therefore no additional LLNA test was performed.
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 260-352 g
No further information is given in the study report. - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 10% (w/w) in aqueous suspension
- Route:
- other: topical and systemic (not further specified)
- Vehicle:
- water
- Concentration / amount:
- 10% (w/w) in aqueous suspension
- No. of animals per dose:
- 12
- Details on study design:
- RANGE FINDING TESTS:
No information provided in the study report.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 6 h
- Test groups: test substance
- Control group: no data
- Site: no data
- Frequency of applications: not specified
- Duration: Days 0-21 days
- Concentrations: 10% (w/w) aqueous suspensio)
B. CHALLENGE EXPOSURE
- No. of exposures: 2 (topical and systemic)
- Day(s) of challenge: 14 days after induction (not further specified)
- Exposure period: no data
- Test groups: test substance
- Control group: no data
- Site: no data
- Concentrations: 10% (w/w) aqueous suspensio)
- Evaluation (hr after challenge): no data - Reading:
- other: after topical challenge
- Group:
- test chemical
- Dose level:
- 10% aqueous suspension
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Remarks on result:
- other: Reading: other: after topical challenge. Group: test group. Dose level: 10% aqueous suspension. No with. + reactions: 0.0. Total no. in groups: 12.0.
- Reading:
- other: after systemic challenge
- Group:
- test chemical
- Dose level:
- 10 % aqueous suspension
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Remarks on result:
- other: Reading: other: after systemic challenge. Group: test group. Dose level: 10 % aqueous suspension. No with. + reactions: 0.0. Total no. in groups: 12.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Justification for grouping of substances and read-across
No data are available on the skin sensitisation potential of Benzoic acid, 4-hydroxy-, C18-22-alkyl esters (CAS 201305-16-0). In order to fulfil the standard information requirements set out in Annex VII in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances is conducted.
In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).
Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006, whereby physicochemical, toxicological and ecotoxicological properties may be predicted from data for reference substance(s) by interpolation to other substances on the basis of structural similarity, the substances depicted in the table below are selected as source substances for assessment.
The read-across is based on the identified structural similarities and the likelihood of common breakdown products by biological processes (metabolism). A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
CAS
201305-16-0
68411-27-8
94-13-3
Chemical Name
Benzoic acid, 4-hydroxy-, C18-22-alkyl esters
Benzoic acid,C12-15-alkyl esters
Propyl 4-hydroxybenzoate
MW
390.60-446.71 g/mol
311 g/mol
180.2 g/mol
Skin sensitisation
RA: CAS 68411-27-8, CAS 94-26-8
Experimental result:
Not sensitising (OECD 406)
Not sensitising (RIPT)
Experimental result:
Not sensitising (secondary source information)
Skin sensitisation
CAS 68411-27-8
A Buehler test is available which was conducted similar to OECD guideline 406, where twelve male guinea pigs, weighing 260-352 g were tested. The animals were treated with 9 topical, occluded applications (duration of treatment 6 hours/day) over a 21 day period. Two challenge applications were performed 14 days later, to determine local and systemic effects. Non-irritating concentrations (10 % (w/w)) were used. No positive reactions were observed, neither after topical challenge, nor after systemic challenge. Therefore the authors of the study report concluded that the test material was not a potential sensitizer in guinea pigs under the experimental conditions chosen.
A Repeated Insult Patch Test (RIPT) was conducted in humans, based on the Draize - Shelanski Test Method. A panel of minimum 200 volunteers was tested for primary or cumulative irritation and/or sensitisation after repeated dermal contact with the test item. The test material was applied at a concentration of 10 % (w/w) in mineral oil.The volar forearm or upper back between the scapulae served as the treatment area. Approximately 0.15 mL of the test material was applied to the gauze portion of a Coverlet adhesive dressing. This was then applied to the treatment site to form an occlusive patch. This procedure was followed three times per week for a total of ten applications. Each site was marked to ensure the continuity of patch application. The participants were instructed to remove these patches after 24 hours. The evaluation of each site was made just prior to re-application. Rest periods consisted of 24 hours following the Tuesday and Thursday removal, and 48 hours following the Saturday removal.At the conclusion of a fourteen day rest period following the –tenth application, a challenge patch was applied to the original site and to a virgin site following the previously described procedure. Each site was then evaluated at 24 and 48 hours after application.No positive reactions were observed, neither for irritation, nor for sensitisation. Thus, the test item is not sensitising or irritating to humans after repeated dermal application of 10% solution in mineral oil.
CAS 94-13-3
In a maximization test with a multiple dosedesign in guinea pigs, Andersen et al. (1995) did not find any significant sensitization potential withPropyl 4-hydroxybenzoate.The concentration ranges used for induction and challenge in the multiple dose GPMT were based on a preliminary pilot study using FCS-treated naive guinea pigs. 5 female albino guinea pigs per test group, weighing between 350 and 450 g at receipt were treated according to the procedure described by Magnussen and Kligman, comprising an intracutaneous induction (0.1, 0.3, 1, 3 and 10%)with FCA on day 0, a topical induction on day 7 (0.3 and 30%)and a subsequent challenge (10%)on day 21 by closed patch tests to the flank of the animal. No pretreatment of the topical induction area with sodium lauryl sulphate was performed. The challenge reactions were blindly read after 48 h and 72 h. No positive reactions were observed for sensitisation. The test item was not sensitising in the GPMT under the experimental conditions chosen. Considering the results of all induction groups, the concurrently tested substances formaldehyde, mercaptobenzothiazole and chlormethylisothiazolinone/ methylisothiazolinone induced each positive reactions in at least 13/25 and up to 24/25 animals (52-96%), thus meeting the reliability criteria for the GPMT (≥ 30% positive response).
Additional experimental data on skin sensitisation for Propyl 4-hydroxybenzoate is available as secondary source only, and reviews. No details on the study designs or raw data are given.In a murine local lymph node assay (LLNA), Basketter et al. (2001) studied several chemicals that can act as contact allergens. In this study,Propyl 4-hydroxybenzoatewas reported as non-sensitizing. In another study, Basketter et al. (1999) determined the threshold of 134 chemicals, includingPropyl 4-hydroxybenzoate, for classification as skin sensitizer.Propyl 4-hydroxybenzoatewas reported negative in the LLNA assay and the guinea pig maximization test (GMPT).
Migrated from Short description of key information:
Skin: not sensitising
Justification for selection of skin sensitisation endpoint:
Hazard assessment is conducted by means of read-across from structural analogues/surrogates. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substances and overall assessment of quality, duration and dose descriptor level (refer to the endpoint discussion for further details).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on read-across from the structurally similar substances, the available data on skin sensitisation do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
There are no data available for respiratory sensitisation.
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.
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