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EC number: 931-472-4 | CAS number: 182700-89-6
- 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:
- 6 March to 15 March 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study to GLP conducted using material that consisted of 65 % active ingredient and 35 % xylene.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
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
Test material
- Reference substance name:
- Benzoic acid, 2-hydroxy-,C14-18 alkyl derivs.
- EC Number:
- 931-472-4
- Cas Number:
- 182700-89-6
- IUPAC Name:
- Benzoic acid, 2-hydroxy-,C14-18 alkyl derivs.
- Reference substance name:
- 605-976-7
- EC Number:
- 605-976-7
- IUPAC Name:
- 605-976-7
- Test material form:
- liquid: viscous
- Details on test material:
- - Physical state: pale brown viscous liquid
- Stability under test conditions: no data
- Storage condition of test material: under nitrogen at ambient temperature in the dark
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: about 5 months
- Weight at study initiation: 3.44 to 3.78 kg
- Housing: individually, in suspended stainless steel cages
- Diet (e.g. ad libitum): conventional, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 1 to 2 months
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 22
- Humidity (%): 32 to 57
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
- Rabbit No.1: From 6 March 1995 to 13 March 1995
- Rabbits Nos. 2 and 3: From 8 March 1995 to 15 March 1995
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single application, not washed out of the eye
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- Three. One animal was initially treated with the test material. As a severe irritation response was not observed, two more rabbits were treated.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: scored according to OECD guideline. Also scored for pain reaction to instillation of the test material and for area of the cornea affected by the lesion and discharge from the conjunctivae.
TOOL USED TO ASSESS SCORE: ophthalmoscope or pencil beam torch. From 24 h fluorescein was used for examination of the cornea, viewed under uv-light.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- other: reversible in 2/3 rabbits within 48 or 72 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- other: fully reversible in 2/3 rabbits within 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: fully reversible in 2/3 rabbits in 48 or 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no reaction
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritant / corrosive response data:
- The sentinel rabbit (No.1) showed a diffuse beefy-red conjunctiva during the first 24 h, which gradually reduced but injection of the blood vessels persisted to study termination on day 8. Iritis, very slight chemosis and slight to moderate discharge with mucus were evident during the first 24 h but had reversed by 48 h, 48 h and 8 days, respectively. No effects on the cornea were apparent.
Animal No.2 showed pink to crimson conjunctiva and very slight or slight discharge (with mucus) during the first 72 h but had mainly reversed by day 8. An area of very slight corneal opacity, very slight or slight chemosis and iritis were seen at 24 and 48 h.
Animal No.3 showed crimson or beefy-red conjunctiva, very slight or slight chemosis, very slight or slight discharge, iritis and opacity of the cornea all of which were still present on day 8. Pannus formation (which is irreversible) affecting both the upper and lower edges of the cornea was evident on day 8, which resulted in the decision to terminate the study at this point. - Other effects:
- The pain response for animal No. 1 upon instillation of the test substance was moderate (grade 3; on a scale of 0 to 5).
Applicant's summary and conclusion
- Interpretation of results:
- Category I
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was irritating when 0.1 mL was instilled into the eyes of three New Zealand White rabbits.
- Executive summary:
In a GLP study conducted according to OECD Guideline 405 and to EU Method B.5, the test material (approximately 65 % active substance, 35 % xylene) was assessed for its irritant potential when instilled into the eyes of three New Zealand White rabbits.
Each animal was treated with 0.1 mL of the undiluted test material in the right eye and the eyelids gently held together for 1 second before releasing. The left eye was untreated and served as a concurrent control.The rabbits were observed at 1, 24, 48 and 72 h and at 8 days after instillation for signs of occular irritation. Initially only one animal was treated which experienced a moderate pain response; to prevent this in the other two animals they were treated with an anesthetic before instillation of the test material (including the control eye).
Moderate to severe conjunctivitis was evident in all three rabbits during the first 72 h after exposure which was not fully reversible by 8 days. Moderate iritis was seen in one animal at 1 and 24 h, at 24 and 48 h in another, and throughout the study in the third. No corneal opacity was evident in one animal, was present at 24 and 48 h in a second and in the third was present from 1 h through to day 8. In this latter animal the irreversible lesion, pannus, was evident on day 8, affecting both the upper and lower edges of the cornea.
In conclusion, the test material was irritating when 0.1 mL was instilled into the eyes of three New Zealand White rabbits, causing pannus in one animal.
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