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EC number: 700-008-0 | CAS number: 3753-18-2
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 26 January 1998 and 4 February 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP standards (Schedule 1, Good Laboratory Practice Regulations 1997 (SI 1997/654))
Test material
- Reference substance name:
- 4,4'-bis(methoxymethyl)-1,1'-biphenyl
- EC Number:
- 700-008-0
- Cas Number:
- 3753-18-2
- Molecular formula:
- C16 H18 O2
- IUPAC Name:
- 4,4'-bis(methoxymethyl)-1,1'-biphenyl
- Reference substance name:
- 4,4-bis(methoxymethyl)-biphenyl
- IUPAC Name:
- 4,4-bis(methoxymethyl)-biphenyl
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.77 to 3.09 kg
- Housing: Animals housed individually in suspended metal cages.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 20°C
- Humidity (%): 50 to 65%
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): controlled by time switch to give 12 hours continuous light followed by 12 hours continuous darkness
IN-LIFE DATES: From: Day of dosing (Day 0) To: Day of sacrifice (Day 7)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1 ml, found to weigh approximately 58 mg
- Concentration (if solution): not applicable
VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable - Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3: - 1 animal for initial assesment, followed by 2 more animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not stated in report
- Time after start of exposure: not stated in report
SCORING SYSTEM:modified version of the Kay and Calandra system
TOOL USED TO ASSESS SCORE: standard opthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- degree of opacity
- Basis:
- animal: 33 Female
- Time point:
- other: Mean of 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effects observed
- Irritation parameter:
- cornea opacity score
- Remarks:
- degree of opacity
- Basis:
- animal: 174 Male
- Time point:
- other: Mean of 24, 48 and 72 hrs
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- degree of opacity
- Basis:
- animal: 201 Female
- Time point:
- other: Mean of 24, 28 and 72 hrs
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effects observed
- Irritation parameter:
- iris score
- Basis:
- animal: 33 Female
- Time point:
- other: Mean of 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effects observed
- Irritation parameter:
- iris score
- Basis:
- animal: 174 Male
- Time point:
- other: Mean of 24, 48 and 72 hrs
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- iris score
- Basis:
- animal: 201 Female
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effects observed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 33 Female
- Time point:
- other: Mean of 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effects observed at 24, 48 or 72 hours
- Remarks on result:
- other: Score of 1 at 1 hour, fully reversed at 24 hrs
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 174 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 201 Female
- Time point:
- other: Mean of 24, 48 and 72 hrs
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 33 Female
- Time point:
- other: Mean of 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effects observed at 24, 48 and 72 hrs
- Remarks on result:
- other: Score of 1 at 1 hr, fully reversed at 24 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal: 174 Male
- Time point:
- other: Mean of 24, 48 and 72 hrs
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: 201 Female
- Time point:
- other: Mean of 24, 48 and 72 hrs
- Score:
- 1.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Score of 2 observed at 1 hr
- Irritant / corrosive response data:
- Diffuse corneal opacity was noted in one treated eye at the 24-hour observation with translucent corneal opacity at the 48-hour observation and diffuse corneal opacity at the 72-hour observation. No other corneal effects were noted.
Iridial inflammation was noted in one treated eye at the 24 and 48-hour observations. no other iridial effects were noted.
Minimal or moderate conjunctival irritation was noted in all treated eyes at the 1-hour observation. Minimal or moderate conjunctival irritation was noted in two treated eyes at the 24-hour observation with minimal conjunctival irritation at the 48-hour observation. Minimal conjunctival redness was noted in one treated eye at the 72-hour observation.
All treated eyes appeared normal at the end of the observation period. - Other effects:
- None noted
Any other information on results incl. tables
The test material did not produce positive criteria in any rabbit according to the EU labelling regulations. No symbol and risk phrases are therefore required.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material did not produce positive criteria in any rabbit according to the EU labelling regulations. No symbol and risk phrases are therefore required.
- Executive summary:
A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 February 1987) and Method B5 of Commisssion Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548 EEC (as adapted to technical progress by commisssion Directive 93/21/EEC) relating to the classification, packaging and labelling of dangerous substances.
A single application of the test material to the non-irrigated eye of three rabbits produced translucent corneal opacity, iridial inflammation and minimal to moderate conjunctival irritation. All treated eyes appeared normal at the end of the observation period.
The test material did not produce positive criteria in any rabbit according to the EU labelling regulations. No symbol and risk phrases are therefore required.
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