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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 500-086-4 | CAS number: 35238-34-7
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4,4'-isopropylidenediphenol
- EC Number:
- 201-245-8
- EC Name:
- 4,4'-isopropylidenediphenol
- Cas Number:
- 80-05-7
- Molecular formula:
- C15H16O2
- IUPAC Name:
- 2,2-bis(4-hydroxyphenyl)propane
- Reference substance name:
- 4,4’-isopropylidenediphenol
- IUPAC Name:
- 4,4’-isopropylidenediphenol
- Reference substance name:
- : Phenol, 4,4’-(1-methylethylidene)bis-
- IUPAC Name:
- : Phenol, 4,4’-(1-methylethylidene)bis-
- Reference substance name:
- Bisphenol A
- IUPAC Name:
- Bisphenol A
- Details on test material:
- As per IUCLID5 Sections 1.1. - 1.4. for Bisphenol A.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- Three male animals from a laboratory supplier, approximately 7-9 months of age with initial body weights of 2.3-2.4 kg were used. Standard rabbit diet of Altromin 2023 (ALTROMIN GmbH, D-32791 Lage/Lippe) was supplied ad Libitum. Drinking water was offered ad libitum before and after the exposure period. The animals were kept singly in cages measuring 425 mm x 600 mm x 380 mm (manufacturer: Dipl. Ing. W. EHRET GmbH, D-16352 Schonwalde). the animals were acclimated at least 20 days. The Environmantal conditions were as follows: -Temperature, 17-23 degrees C, -Humidity, 30-70%, -Photoperiod, 12 hours light (150 lux at approximately 1.5 meter room height)/12 hours dark.
Test system
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- The test substance was ground to a fine dust and 100 mg was used per animal.
- Duration of treatment / exposure:
- Single instillation into the conjunctival sac, no wash-out.
- Observation period (in vivo):
- 28 days
- Number of animals or in vitro replicates:
- Three males
- Details on study design:
- Three male Himalayan rabbits were treated with 100 mg test substance by a single instillation into the conjunctival sac of the right eye. The eye lids were then gently held together for one second to prevent loss of the material. The left eye, which remained untreated, served as a control. The eyes of the animals were not rinsed. The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48, and 72 hours and 4 to 28 days after administration. The eye reactions were observed and recorded At 24 hours, 7, 14, and 28 days after administration, the eyes were treated with Fluorescein SE Thilo eye drops (Alcon Pharma GmbH, D-79108, Freiburg, Germany) and examined for trama.
Results and discussion
In vivo
Results
- Irritation parameter:
- chemosis score
- Basis:
- animal: One animal only exhibited this score.
- Time point:
- other: One hr to day four.
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: All other scores were graded 1.
- Irritant / corrosive response data:
- Corneal opacity (grade 1) was observed in all three animals 1 hour to 9 days after instillation; in animal #2 until 13 days; and in animal #3 until 28 days after instillation. The fluorescein test performed after 24 hours revealed corneal staining in all 3 rabbits (whole surface). The fluorescein test performed after 7 days revealed corneal staining in animal #1 and animal #2 (3/4 of the corneal surface) and in animal #3 (whole surface). The fluorescein tests performed after 14 and 21 days revealed corneal staining in animal #3 (1/2 of the corneal surface). An irritation of the iris (grade 1) was observed in all three animals one hour to 9 days after instillation, and in animal #2 until 11 days and in animal #3 until 28 days after instillation. Conjunctival redness (grade 1) was observed in all animals one to 24 hours after instillation, in animal #2 until 4 days and in animal #3 until 6 days after instillation. Conjunctival chemosis (grade 1) was observed in animal #1 and animal #2 24 hours after instillation and in animal #3 one hour to 4 days (grade 2) and 5 and 6 days (grade 1) after instillation. Whitish deposits in the conjunctival sac (probably pus) were observed in animal #2 and animal #3 from 72 hours to 5 days after instillation.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Based primarily on the persistence of the occular lesions observed including corneal opacity the test substance is considered to be irritating to the rabbit eye. However, mean ocular lesion scores are insufficient for Classification and Labeling. These data for the structural analog, Bisphenol A, suggest that 2-Acetone polymer with phenol (BPA-Tars) may be an eye irritant.
- Executive summary:
A structural analog of 2 -Acetone polymer with phenol (BPA-Tars), Bisphenol A, was evaluated for eye irritation potential by an O.E.C.D. No. 405 Test Guideline study conducted with GLP compliance. Based primarily on the persistence of the occular lesions observed including corneal opacity the test substance is considered to be irritating to the rabbit eye. However, mean ocular lesion scores are insufficient for Classification and Labeling. These data for the structural analog, Bisphenol A, suggest that BPA-Tars may be an eye irritant.
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.