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EC number: 225-193-0 | CAS number: 4707-47-5
- 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:
- 20 February, 1980 - 29 February, 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Study is not conducted under GLP
- Justification for type of information:
- The information is from 1980. At the time no in vitro test methods were available.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- GLP compliance:
- no
Test material
- Reference substance name:
- Methyl 2,4-dihydroxy-3,6-dimethylbenzoate
- EC Number:
- 225-193-0
- EC Name:
- Methyl 2,4-dihydroxy-3,6-dimethylbenzoate
- Cas Number:
- 4707-47-5
- Molecular formula:
- C10H12O4
- IUPAC Name:
- methyl 2,4-dihydroxy-3,6-dimethylbenzoate
- Test material form:
- other: solid
1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: Yound adults
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: Singly housed
- Diet: Daily 100g of Purina Rabbit Chow supplemented by whole oats.
- Water: Free access to water
- Acclimation period: No data.
ENVIRONMENTAL CONDITIONS
No data.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 100mg - Duration of treatment / exposure:
- Single instillation.
- Observation period (in vivo):
- 24, 48 and 72 hours and 4, 7 and 10 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- TREATMENT:
On the day of dosing, the lower lid was everted from the eyeball of the right eye to form a cup into which the test substance was placed. The eyelid was then gently held together for one second.
REMOVAL OF TEST SUBSTANCE
Eyes were not washed.
SCORING SYSTEM:
The ocular reaction of both eyes were scored according to the Method of Draize (see table) 24, 48 and 72 hours and 4 and 7 days after administration.
Scoring table:
0.0 - 0.5: non-irritating
0.6 - 10.0: practically non-irritating
10.1 - 25.0: mildly irritating
25.1 - 50.0: moderately irritating
50.1 - 110.0: extremely irritating
TOOL USED TO ASSESS SCORE:
At 24 hours and 7 days, both eyes of each animal were examined with fluorescein stain under an ultra violet light. Any persistent changes observed on Day 7 were re-evaluated on Day 10 using a hand held ophthalmoscope and the fluorescein method described previously.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1, #2, #3, #4, #5 and #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1, #2, #3, #4, #5 and #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- animal #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- animal #1, #4, #5 and #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1, #2, #3, #4, #5 and #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The dosed eyes of two rabbits had slight reddening of the conjuctivae observed at 24 hours only. The other four rabbits had normal eyes. At 48 hours and subsequently all eyes were normal. There was no fluorescein retention at any time period.
No animal had a positive score on day 7 and, in accordance with the protocol, none were retained for examination on day 10.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- According to Regulation (EC) No 1272/2008 and its amendments.
- Conclusions:
- In an eye irritation study with 6 rabbits, performed equivalent to OECD 405 guideline, two rabbits had slight reddening of the conjuctivae observed at 24 hours only. The other four rabbits had normal eyes. All signs of irritation were reversible within 48 hours.
- Executive summary:
The substance was tested in an eye irritation test in 6 rabbits equivalent to OECD TG 405 test guideline. The substance caused slight reddening of the conjuctivae in two animals at 24 hours only. The other four rabbits had normal eyes. At 48 hours and subsequently all eyes were normal. There was no fluorescein retention at any time period. Based on the results, the substance does not need to be classified for eye irritation according to EU CLP (EC No. 1272/2008 and its amendments).
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