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EC number: 429-290-0 | CAS number: 3380-30-1
- 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:
- 1998-12-7 to 1998-12-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study, GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- (1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1987)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 429-290-0
- EC Name:
- -
- Cas Number:
- 3380-30-1
- Molecular formula:
- C12 H8 Cl2 O2
- IUPAC Name:
- 5-chloro-2-(4-chlorophenoxy)phenol
- Details on test material:
- - Name of test material (as cited in study report): FAT 80'220/A
- Physical state: solid, powder
- Analytical purity: >99 %
- Lot/batch No.: GRU 98
- Expiration date of the lot/batch: 2008-10-31
- Stability under test conditions: stability of test item in bidistilled water not specified.
- Storage condition of test material: in the original container at room temperature (approx. 20°C) away from direct sunlight; the test item was stable under storage conditions.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, Chatillon sur Chalaronne, France
- Weight at study initiation: 2913 g (female), 3200 g (female), 2890 g (male)
- Age at study initiation: 15 weeks
- Housing: Individually in stainless steel cages
- Diet: Pelleted standard Provimi Kliba 3410 rabbit maintenance diet ad libitum
- Water: Community tap water from Itingen, ad libitum, in water bowls
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 40- 70 %
- Air changes (per hr): 10 - 15 air changes/ hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and served for control
- Amount / concentration applied:
- On the day of treatment, approximately 0.1 g of unchanged test item was placed into the conjunctival sac of the left eye of each animal; the lids were then gently held together for about one second to prevent loss of test article. The treated eyes were not rinsed after application.
- Duration of treatment / exposure:
- The treated eyes were not rinsed after application.
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- READING
Reading of the eye was done at 1, 24, 48 and 72 hours, as well as at day 7, 14 and 21 post application.
SCORING SYSTEM
The ocular reaction was assessed according to the numerical scoring system recommended by the guideline and was based on the Draize scoring system. When present, corrosion and/or staining of sclera and cornea by the test item were recorded.
TOOL USED FOR EXAMINATION
Varta Cliptrix diagnostic-lamp (A. Riegger, Basel/Switzerland)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: the animal showed no corneal opacity
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Corneal opacity graded 1 was seen until day 21 of observation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Corneal opacity graded 1 was seen until day 7 of observation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no effects in the iris were seen.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no effects in the iris were seen.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no effects in the iris were seen.
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- animal 1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Redness of the conjunctivae graded 1 was seen at time point 1 hour. Redness was graded 2 at 24, 48 and 72 hours, and turned back to grade 1 at day 7. Thereafter, the finding was no more evident.
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- animal 2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Redness of the conjunctivae graded 1 was seen at all considered time points and still was evident at day 21.
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- animal 3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Redness of the conjunctivae graded 1 was seen at time point 1 hour and became more severe thereafter, reaching grade 2 at 24, 48 and 72 hours, respectively. From day 7 to 21, redness graded 1 still was evident.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Chemosis appeared at time point 24 hours and was graded 3. Chemosis graded 2 and 1 was seen at 48 and 72 hours, respectively. At time point 7 days, the finding was no more evident.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Chemosis graded 1 was seen from time point 1 hour until time point 7 days and was no more evident thereafter.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Chemosis was graded 2 at time point 1 hour, 3 at 24 hours, 2 at 48 hours and 1 at 72 hours. Chemosis graded 1 lasted until day 7 and was no more evident thereafter.
- Irritant / corrosive response data:
- In all animals, reddening (including hyperemia of the scleral blood vessels) and swelling of the conjunctivae, swelling of the nictitating membrane, as well as watery discharge was observed. In two animals, slight opacity and mucous discharge was evident. Hyperemia of the scleral blood vessels persisted in all animals until the end of the observation period. In two animals, conjunctival redness and in one animal, opacity was noted until 21 days after treatment.
- Other effects:
- No staining of the treated eyes by the test item was observed.
No signs indicating corrosion were observed at any of the reading time points.
Neither mortality nor clinical signs of toxicity were observed.
Applicant's summary and conclusion
- Interpretation of results:
- other: The test item causes severe damage to the eye; according to current evaluation criteria, the test item is to be classified - Xi, R41 according to EU Directive 67/548/EC and Cat 1 according to the CLP Regulation 1272/2008.
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