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EC number: 202-462-0 | CAS number: 95-88-5
- 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:
- 10.11. - 11.11. 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
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:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-chlororesorcinol
- EC Number:
- 202-462-0
- EC Name:
- 4-chlororesorcinol
- Cas Number:
- 95-88-5
- Molecular formula:
- C6H5ClO2
- IUPAC Name:
- 4-chlorobenzene-1,3-diol
- Test material form:
- other:
- Remarks:
- beige powder
- Details on test material:
- Molecular weight: 144.65
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Age: at least 6 weeks
Body weight: between 1.0 and 3.5 kg
Conditions:
Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 t 3.0°C (actual range: 19.2 - 21.8"C), a relative humidity of 30-70% (actual range: 37 - 67%) and 12 hours artificial
fluorescent light and 12 hours darkness per day.
Accommodation:
Individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56~44~37c.m5 ). Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
Diet:
Standard laboratory rabbit diet, approx. 100 g/day.
Water:
Free access to tap-water.
Test system
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1 h and 24 h
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- A health inspection was performed prior to commencement of treatrnent, to ensure that the animal was in a good state of health. Special attention was paid to the eyes, which were free from any abnormality.
On test day 1, 56.1 mg of the test substance (a volume of approximately 0.1 ml) was instilled in the conjunctival sac of an eye of one animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test
substance. The other eye remained untreated and served as the reference control.
lmmediately after the 24-hour observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes to quantitatively determine corneal epithelial damage. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the
total corneal area. Based on the severity of the ocular lesions observed during the study, the animal was sacrificed for ethical reasons immediately after the 24 hours observation and the two further rabbits assigned to the study were not treated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: remnants of the test substance in the eye; brownish staining of the fur on head and paws by the test substance; grey/white discolouration of the eyelids and nictating membrane
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: redness of the outside of the eyelids; remnants of the test substance in the eye; brownish staining of the fur on head and paws by the test substance; grey/white discolouration of the eyelids and nictating membrane
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Remarks on result:
- other: no scoring possible due to corneal irritation.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Remarks on result:
- other: no scoring possible due to corneal irritation.
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 3
- Max. score:
- 3
- Remarks on result:
- other: remnants of the test substance in the eye; brownish staining of the fur on head and paws by the test substance; grey/white discolouration of the eyelids and nictating membrane
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 3
- Remarks on result:
- other: redness of the outside of the eyelids; remnants of the test substance in the eye; brownish staining of the fur on head and paws by the test substance; grey/white discolouration of the eyelids and nictating membrane
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: remnants of the test substance in the eye; brownish staining of the fur on head and paws by the test substance; grey/white discolouration of the eyelids and nictating membrane
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: redness of the outside of the eyelids; remnants of the test substance in the eye; brownish staining of the fur on head and paws by the test substance; grey/white discolouration of the eyelids and nictating membrane
- Irritation parameter:
- other: Discharge
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 3
- Remarks on result:
- other: remnants of the test substance in the eye; brownish staining of the fur on head and paws by the test substance; grey/white discolouration of the eyelids and nictating membrane
- Irritation parameter:
- other: Discharge
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 3
- Remarks on result:
- other: redness of the outside of the eyelids; remnants of the test substance in the eye; brownish staining of the fur on head and paws by the test substance; grey/white discolouration of the eyelids and nictating membrane
- Irritant / corrosive response data:
- Instillation of 56.1 mg of A 012 (a volume of approximately 0.1 ml) into an eye of one rabbit resulted in effects on the Cornea and conjunctivae. The corneal injury consisted of opacity (maximum .grade 4) and epithelial damage (100% of the corneal area). The irritation of the conjunctivae consisted of redness (also of the outside of the eyelids), chemosis and discharge. In addition, grey-white discolouration (a sign of necrosis) of the eyelids and nictitating membrane was noted during the observation period. Due to the corneal damage, iridial irritation could not be assessed. Based on the severity of the eye lesions, the ariimal was sacrificed for ethical reasons after the 24 hours observation. The other animals assigned to the study were not treated.
- Other effects:
- Colouration I Remnants
Remnants of the test substance were present in the eye at 1 and 24 hours after instillation. Brownish staining of the fur on the head and paws noted during the observation period was considered to have been caused by the animal's attempt to rub out test substance remnants andlor stained lachrymal fluid from the eye.
Toxicity/ Mortality
No symptoms of systemic toxicity were observed in the animal during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Conclusions:
- Based on the degree and persistence of the eye lesions, it was concluded that ocular corrosion had occurred by instillation of A 012 into the rabbit eye.
Based on these results and according to the:
- OECD Harmonized lntegrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998),
A 012 should be classified as : having irreversible effects on the eyes (Class 1).
- EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC), A 012 should be labelled as: risk of serious damage to eyes (R 41). - Executive summary:
Acute eye irritation/corrosion study with A 012 in the rabbit.
The study was carried out based on the guidelines described in: "Acute Toxicity - Eye irritation", OECD No.405 (2002), EC Commission Directive 92/69/EEC, 8.5, "Acute Eye Irritation/Corrosion" (1992) and US EPA, OPPTS 870.2400, Acute Eye Irritation, EPA 712-C-98- 195, August 1998 and JMAFF guidelines (2000).
A single sample of 56.1 mg of A 012 (a volume of approximately 0.1 ml) was instilled into an eye of one rabbit. Observations were made 1 and 24 hours after instillation.
Instillation of the test substance resulted in effects on the cornea and conjunctivae. The corneal injury consisted of opacity (maximum grade 4) and epithelial damage (100% of the corneal area). The irritation of the conjunctivae consisted of redness (also of the outside of the eyelids), chemosis and discharge. In addition, grey-white discolouration (a sign of necrosis) of the eyelids and nictitating membrane was noted during the observation period. Due to the corneal damage, iridial irritation could not be assessed.
Based on the severity of the eye lesions, the animal was sacrificed for ethical reasons after the 24 hours observation. The other animals assigned to the study were not treated.
Remnants of the test substance were present in the eye at 1 and 24 hours after instillation. Brownish staining of the fur on the head and paws noted during the observation period was considered to have been caused by the animal's attempt to rub out test substance remnants andlor stained lachrymal fluid from the eye. Based on the degree and persistence of the eye lesions, it was concluded that ocular corrosion had occurred by instillation of A 012 into the rabbit eye.
Based on the degree and persistence of the eye lesions, it was concluded that ocular corrosion had occurred by instillation of A 012 into the rabbit eye. Based on these results and according to the:
- OECD Harmonized lntegrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998), A 012 should be classified as: having irreversible effects on the eyes (Class 1).
- EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC),
A 012 should be labelled as: risk of serious damage to eyes (R 41).
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