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EC number: 609-080-7 | CAS number: 35160-38-4
- 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:
- Apr - May 2004
- 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:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: charles River Deutschland GmbH, Kißlegg, Germany
- Weight at study initiation: 2.3 - 3.7 kg
- Housing: in separate cages
- Diet (e.g. ad libitum): ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 1 week under study conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
From: 27.04. To: 18.05.2004
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The eye remained untreated and was used for control purposes.
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- 24 h after administration the treated eyes were washed out with isotonic saline at approx. 37°C
- Observation period (in vivo):
- 1 hour and 24, 48 and 72 hours as well as 7 and 14 days following treatment
At 24 and 72 hours and after 7 and 14 days, the eyes were further examined for corneal lesions under UV light after instillation of one drop of 0.01 % Fluorescein-sodium - Number of animals or in vitro replicates:
- 3
- Details on study design:
- Test Item Administration:
The test item was applied as a weight of 0.1 g/animal, the dose specified in the test guidelines for solid test items.
An initial test was performed using one animall.
As neither serious eye damage nor severe effect were observed in the initial test a confirmatory test with two further animals was performed.
About 24 h before the stert of the study both eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01% fluorescein-sodium solution. Only animals without ocular abnormalies were used for the study. 0.1 g of the test item was administered once to the conjuntival sac of the left eye of three rabbits. In each case the untreated eye served as control.
24 h after administration the treated eyes were washed out thoroughly with isotonic saline at approx. 37°C. The eyes were also washed out at designated examination times at which discharge was observed or a corneal examination with fluorescein was performed.
Rationale: No study on eye irritation was available. The test item is not classified as corrosive or irritating to skin.
Observations
Viability / Mortality: Daily
Clinical Signs: Daily
Eye Reactions: See below
Body Weights: At start of acclimatization, on test day 1 and at termination of observation.
Assessment of Eye Reactions:
The eye reactions were assessed according to the numerical scoring system listed in the Commission Regulation (EC) No 440/2008, B.5, at approximately 1, 24, 48 and 72 hours, as well as 7 days after administration. Scleral reddening and ocular discharge were also assessed. Eye examinations were made with a Varta Cliptrix diagnostic-lamp (Roth AG, 4153 Reinach / Switzerland)
Data was summarized in tabular form, showing for each animal the irritation scores for the designated observation time, a description of the degree and nature of irritation, the presence of serious lesions and non-ocular effects. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values (with the exception of the sclerae) for each type of lesion.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.44
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritant / corrosive response data:
- From one hour up to 7 days after administration two animals showed some definitely injected up to crimson colored blood vessels. Slight swelling with partial up to half closed eyelids was observed till 24 hour after application. The third animal showed only one hour up to 24 hours after treatment some hyperaemic up to crimson colored vessels in the conjunctiva as well as obvious swelling with partial eversion of lids one hour after application. Additionally, serous colorless eye discharge was noted one hour after administration in all animals.
14 days after administration all signs of irritation had disappeared. - Other effects:
- No clinical signs of systemic toxicity were observed.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- According to the findings in this study the substance does not meet the criteria for classification laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
- Executive summary:
The substance was tested for its eye irritant properties in 3 New Zealand White rabbits. The study was performed according to OECD Guideline 405. Effects on conjunctivae (redness and swelling) were observed in all animals one hour after application. These signs decreased significantly within 72 hours and were fully reversible within 14 days.
According to the findings in this study the substance does not meet the criteria for classification laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
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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