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EC number: 429-460-4 | CAS number: 7078-98-0
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
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)
Test material
- Reference substance name:
- Substituted Quinone Methide
- IUPAC Name:
- Substituted Quinone Methide
- Details on test material:
- Storage: The test article was stored at room temperature and humidity.
Description: Yellow crystalline solid.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: New Zealand White rabbits were received from Ace Animals, Boyertown, PA.
- Age at study initiation: Approx 3 months.
- Weight at study initiation: The pretest bodyweight range was 2.0-2.1 kg.
- Housing: The animals were housed 1 per cage in suspended cages. Bedding was placed beneath the cages and changed at least three times/week.
- Diet (e.g. ad libitum): Fresh Purina Rabbit Chow (Diet #5321) was provided daily.
- Water (e.g. ad libitum): Water was available ad libitum.
- Acclimation period: At least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): The animal room was temperature controlled.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test article (0.1 ml equivalent (88 mg)) was placed by syringe-type applicator into the conjunctival sac which was formed by gently pulling the lower eyelid away from the eye. After instillation, the lids were held together for approximately one second to insure adequate distribution of the test article.
One eye of each rabbit was dosed. The contralateral eye served as a control. - Duration of treatment / exposure:
- A single application of the test material.
- Observation period (in vivo):
- 72 hours.
- Number of animals or in vitro replicates:
- 6 females.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not performed.
SCORING SYSTEM: Ocular reactions were graded according to the numerical Draize technique (see below).
TOOL USED TO ASSESS SCORE: Using a Mini-Maglite flashlight equipped with a high intensity bulb, the treated eye of each rabbit was
examined for irritation of the comea, iris and conjunctiva at 1, 24, 48, and 72 hours post dose. The eyes were scored again on day 7. Sodium fluorescein was used to determine corneal effects following the 24 hour observation and at each subsequent reading until there was no stain retention.
The eyes were not scored on day 4 as specified in the protocol. This did not effect the outcome of the study.
Other:
Body weights were recorded pretest.
The general health of the animals was monitored at each observation time.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- : redness
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.72
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Calculated on the basis of the scores at 24, 48, and 72 hours for ALL animals.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: Calculated on the basis of the scores at 24, 48, and 72 hours for ALL animals.
- Irritation parameter:
- conjunctivae score
- Remarks:
- : discharge
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: Calculated on the basis of the scores at 24, 48, and 72 hours for ALL animals.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: Calculated on the basis of the scores at 24, 48, and 72 hours for ALL animals.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 1 day
- Remarks on result:
- other: Calculated on the basis of the scores at 24, 48, and 72 hours for ALL animals.
- Irritant / corrosive response data:
- Corneal opacity, noted in 1/6 eyes, cleared by 48 hours. Iritis, noted in 2/6 eyes, cleared by 24 hours. Conjunctival irritation, noted in 6/6 eyes,
cleared by day 7.
There were no abnormal systemic observations.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not classified as an eye irritant.
- Executive summary:
Objective:
To determine the potential of the test article to produce ocular irritation when instilled in the eyes of New Zealand White rabbits. The study was designed to comply with the standards set forth by:
-EPA - Primary Eye Imtation, 40 CFR 798.4500 (latest revision -1995
-EC Official Journal of the European Communities. L 383 A, Part B, Method B.5 Acute Toxicity (Eye Initation) 12/29/92.
-OECD Guidelines for Testing of Chemicals, No. 405, Acute Eye Initation/Corrosion, adopted 2/24/87.
Method Synopsis:
Six healthy New Zealand White rabbits (females), free from evidence of ocular irritation and corneal abnormalities, as determined by pretest fluorescein procedures, were dosed with the test substance. The test article (0.1 ml equivalent (88 mg)) was placed into the conjunctival sac of one eye of each rabbit. The eyes were examined and scored by the Draize technique at 1, 24, 48 and 72
hours post dose. The eyes were scored again on day 7. Sodium fluorescein was used to determine corneal effects following the 24 hour observation and at each subsequent reading until there was no stain retention. Body weights were recorded pretest.
Summary:
Corneal opacity, noted in 1/6 eyes, cleared by 48 hours. Iritis, noted in 2/6 eyes, cleared by 24 hours. Conjunctival irritation, noted in 6/6 eyes, cleared by day 7.
There were no abnormal systemic observations.
Conclusion:
The test substance is not classified as an eye irritant.
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