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EC number: - | CAS number: -
- 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:
- May 09, 2007 - May 22, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study conform with Directive 2004/73/EC, B.5, OECD Guideline No. 405
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- Test system: Young Adult New Zealamd White Rabbit, SPF
Rationale: Recongnized by the international guidelines as the recommended test system.
Source: Harlan Netherlands BV, Kreuzelweg 53, NL-5961 NM Horst / The Netherlands Postbus 6174, NL-5960 AD
Horst / The Netherlands
See information below "Details on test animals"
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
Species / Strain: Young Adult New Zealamd White Rabbit, SPF
Number of animals per test: 3 (Animals of both sexes were used)
Age at treatment: 12 weeks (male), 15 weeks (females)
Identification: By unique cage number and corresponding ear number.
Acclimatization: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
Allocation: Male No. 64, Female Nos. 65, 66
Housing: Individual in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks 4642 were provided for gnawing
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum.
- Water (e.g. ad libitum): Community tap water
ENVIRONMENTAL CONDITIONS
Temperature (°C): 17-23°C (Air-conditioned)
Humidity (%): 30-70% , 10-15 air changes per hour
Photoperiod: 12 hours light and 12 hours dark
Music was played during the daytime light period.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and served as the reference control.
- Amount / concentration applied:
- 0.1 g (per animal) of AES was weighed and applied undiluted as it was delivered by the sponsor.
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48, 72 hours and 7 days.
- Number of animals or in vitro replicates:
- 3 (Animals of both sexes were used).
- Details on study design:
- TREATMENT:
The eyes of the animals were examined one day prior to test item administration.
On the day of treatment, 0.1 g of AES was placed in the conjunctival sac of the left eye of each 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 test item.
The treated eyes were not rinsed after instillation.
OBSERVATIONS:
Viability/Mortality / Clinical signs: Daily from acclimatization of the animals to the termination of test.
Body weights: At start of acclimatization, on the day of application and at termination of observation.
EYE OBSERVATION TIME POINTS AND TERMINATION:
The eyes of each animal were examined approximately 1, 24, 48, 72 hours , as well as 7 days after administration.
Eye examinations were made with a Varta Cliptrix diagnostic-lamp (Roth AG, CH-4153 Reinach/Switzerland).
NECROPSY:
No necropsy was performed on the animals sacrificed at termination of observation.
The animals were killed by intravenous injection of Pentobarbitone into the ear vein at a dose of at least 1 mL/kg body weight and discarded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: After 24, 48 and 72 hours
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours after instillation
- Score:
- 0 - 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks:
- no longer evident 7 days after treatment
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours after instillation
- Score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals.
No abnormal findings were observed on the treated eye of any animal 7 days after treatment, the end of the observation time.
No corrosion of the cornea was observed at any of the reading times. - Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
No staining of the treated eyes produced by the test item was observed.
The body weights of all rabbits were considered to be within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Base upon the referred classification criteria (commission Directive 2001/59/EC of August 2001), AES is considered to be "Not Irritation" to rabbit
eye. - Executive summary:
The mean score was calculated across 3 scoring times for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for the conjunctivae were 0.00 for all three animals. The individual mean scores for the conjunctivae were 1.00, 0.33 and 0.00 for reddening, respectively and 0.00 for chemosis for each of the three animals.
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.
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