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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-402-6 | CAS number: 106-48-9
- 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:
- April to June 1980
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Remarks:
- Test procedure in accordance with generally accepted scientific standards and described in sufficient detail. Applicant assessment indicates that any deviation from current guidelines would not have affected the study outcome.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4-chlorophenol
- EC Number:
- 203-402-6
- EC Name:
- 4-chlorophenol
- Cas Number:
- 106-48-9
- Molecular formula:
- C6H5ClO
- IUPAC Name:
- 4-chlorophenol
- Test material form:
- 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: Recognised supplier
- Age at study initiation: unspecified
- Weight at study initiation: 3 - 4 kg
- Housing: individually housed in rabbit cages.
- Diet: Standard mixed rabbit food, ad libitum.
- Water: Water, ad libitum
- Acclimation period: Time not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Unspecified; ambient laboratory temperature.
- Humidity (%): Unspecified; ambient laboratory humidity.
- Air changes (per hr): Unspecified.
- Photoperiod (hrs dark / hrs light): Unspecified.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg (per animal)
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- A quantity of 50 mg of the undiluted test material, was placed into the conjunctival sac of one eye. The other eye remained untreated.
- Observation period (in vivo):
- Ocular assessment was conducted daily over the following 7 days.
- Number of animals or in vitro replicates:
- 2 (1 male and 1 female).
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Unspecified; applicant assessment: assumed none.
SCORING SYSTEM:
The ocular reaction was described in the report in prose at daily intervals after instillation, for the following 7 days. Applicant assessment indicates that the prose description contains sufficient detail for the results to be interpreted according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992. This scoring system is consistent with Draize scoring system. When present, corrosion and/or staining of conjunctivae, sclerae and cornea by the test item were recorded and reported.
TOOL USED TO ASSESS SCORE: Eye examinations were made manually, equipment details are unspecified. Applicant assessment indicates that no special equipment would be necessary to determine the outcome of the study (from the description, the results would have been clearly visible to the naked eye).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 0 - 7d
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: mean; n=2. Cornea totally corroded.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 0 - 6d
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: mean; n=2. Strong reddening.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: mean; n=2. Moderate reddening.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 0 - 6d
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: mean; n=2. Strong reddening.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: mean; n=2. Moderate reddening.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 0 - 7d
- Max. score:
- 4
- Remarks on result:
- not measured/tested
- Remarks:
- Iris observations not reported; Applicant assessment indicates this would have been deemed either not possible or unnecessary due to severe corneal corrosion.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Indication of corrosion
- Remarks:
- Cornea totally corroded
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Indication of corrosion
- Remarks:
- Cornea totally corroded
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Remarks:
- Severe reddening
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Remarks:
- Severe reddening
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Remarks:
- Strong reddening
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Remarks:
- Strong reddening
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Remarks:
- Iris observations not reported; Applicant assessment indicates this would have been deemed either not possible or unnecessary due to severe corneal corrosion, thereby not having any effect on the classification of the substance.
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Remarks:
- Iris observations not reported; Applicant assessment indicates this would have been deemed either not possible or unnecessary due to severe corneal corrosion, thereby not having any effect on the classification of the substance.
- Irritant / corrosive response data:
- "Total corrosion" of the cornea was noted at all observations. "Strong reddening" of the conjunctivae of treated eyes was observed immediately and for the following 6 days after treatment, although partially resolved to "moderate reddening" by the final observation. "Strong" chemosis of the conjunctivae was observed in both animals immediately after treatment, for the following 6 days, which reduced to "moderate" chemosis by the final observation. An iris score was not recorded in the study report. Applicant assessment indicates that this would not change the classification of the substance.
- Other effects:
- - Lesions and clinical observations:
Total corrosion of the cornea; strong irritation of the conjunctiva with only partial reversal by the end of the study.
- Ophthalmoscopic findings: None reported.
- Histopathological findings: Not applicable.
- Effects of rinsing or washing: Not applicable.
- Other observations: Not applicable.
Any other information on results incl. tables
Table 1. Individual scores and mean scores for the 7 day observation period
Organism number | 1 | 2 | ||
Time After Treatment | 0 - 6 days | 7 days | 0 - 6 days | 7 days |
CORNEA | ||||
Degree of Opacity | 4 | 4 | 4 | 4 |
Mean (24 – 72 h) | ||||
Area of Cornea Involved | 4 | 4 | 4 | 4 |
IRIS | Not assessed | Not assessed | Not assessed | Not assessed |
Mean (24 – 72 h) | ||||
CONJUNCTIVAE | ||||
Redness | 3 | 2 | 3 | 2 |
Mean (24 – 72 h) | ||||
Chemosis | 4 | 3 | 4 | 3 |
Mean (24 – 72 h) | ||||
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the test item is strongly irritating and corrosive to the eye.
- Executive summary:
The study was performed historically to a guideline similar to OECD TG 405 and EU Method B.5 to assess the irritancy potential of the test item to the eye following a single application in the New Zealand White rabbit. Applicant assessment indicates that any deviation from the current guidelines would not have a significant effect on the study outcome. A volume of 50 mg of the test material was placed into the conjunctival sac of one eye of two rabbits. The other eye remained untreated. Assessment of ocular damage/irritation was made daily for 7 days following treatment. A single application of the test item to the non-irrigated eye of two rabbits produced immediate total corrosion of the cornea. "Strong" redness of the conjunctivae was observed in all treated eyes immediately after treatment, which persisted for 6 days. This reduced to "moderate" redness by the final (day 7) observation. "Strong" chemosis was observed in both treated eyes immediately after treatment, persisting for the following 6 days. This reduced to "moderate" chemosis by the final (day 7) observation. The study authors note "Aufgrund der stark ausgepraegten Reiz- und Aetzwirkung ist jedoch jeder Haut- und Schleimhautkontakt (Auge) mit dem Pruefmuster unbedingth zu vermeiden.", i.e. "Due to the pronounced irritant and caustic effect, any skin and mucous-membrane contact (eye) with the test item must be avoided." Furthermore, the authors note, "...jeglicher Haut- und Schleimhautkontakt (Auge) ist unbedingt zu vermeiden.", i.e. "any contact with skin or mucous membranes (eye) should be avoided at all costs". Under the conditions of this study, the test item is therefore considered to be strongly irritating and corrosive to the eye.
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.