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EC number: 279-075-9 | CAS number: 79135-28-7
- 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
- Remarks:
- source of read-across
- Adequacy of study:
- key study
- Study period:
- From April 13th to May 1st, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Details on the read-across are available in section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Source: BRL, Biological Research Laboratories Ltd. Wolferstrasse 4, CH-4414 Fullinsdorf
Number of animals: 2 male, 1 female
Age at start of treatment: male, 15 weeks, females 16 weeks
Body weight at start of or treatment: male 2.7-2.9 kg, females: 2.3 kg
Identification: by unique cage number and corresponding ear tags.
Acclimatization: four days under test conditions after veterinary examination.
Allocation: Animal Numbers, Male no 96-97 Female nos. 98
HUSBANDRY
Room no.: 138
Standard Laboratory Conditions:
Air-onditioned with 10-15 air changes per hour and hourly monitored environment with temperature 20±3 °C, relative humidity 40-70%, 12 hours artificial fluorescent light/12 hours dark, music/light period.
Accommodation: individually in stainless steel cages equipped with an automatic cleaning and drinking system.
Diet: pelleted standard Kliba 341, Batch 52/90 rabbit maintenance diet (“Kliba”, Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum.
Analysis for contaminants performed.
Water: community tap water from Itingen, ad libitum
Analysis for contaminants performed.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g of test substance
- Observation period (in vivo):
- Viability, mortality: daily
Body weight: start of acclimatization, day 1 of test (application day) and at termination of observation.
The eye reaction were examined at 1, 24, 48 and 72 hours, 7 and 14 days after administration. - Number of animals or in vitro replicates:
- 2 males, 1 female
- Details on study design:
- The eyes of the animals were observed one day prior to test article administration.
On test day 1, 0.1 g or the test article was placed in the conjunctival sac or the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together ror about one second to prevent loss or the test article. The right eye remained untreated and served as the reference control.
In cases of equivocal results when comparing the treated and untreated eyes, the illustrated guide rrom the Consumer Product Safety Commission Washington, D.C. 20207 would be used for additional control purposes.
Eye examinations were made with a slit—lamp 30 SL/M (C. Zeiss AG, Zuerich/Switzerland) and a Varta Cliptrix diagnostic—lamp (A. Riegger, Basel/Switzerland).
The observation was terminated 14 days after administration of the test article.
No necropsy was performed in the animals killed at termination of observation. All rabbits were killed by an intravenous injection of T61 (Hoechst/AG) into the ear vein and discarded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: not rinsed
- Irritant / corrosive response data:
- No vascularization was observed.
No acute clinical symptoms were observed in the animals during the test period and no mortality occurred.
In the area or application a yellow staining of the cornea and conjunctivae by pigment or coloring of the test article was observed.
Opacity was observed in two animals between 1 hour and 7 days and in one animal between 1 to 72 hours after test article administration. - Other effects:
- The body weight gain of all rabbits was similar.
No necropsy was performed. All animals were killed and discarded.
Any other information on results incl. tables
To calculate the irritation effect all scores of each animal at each of the following reading times (24, 48, 72 hours) were used in calculating the respective mean values (Council Directive 83/467/EEC, July 1983 and 67/548/EEC, May 1987, Brussels, Belgium).
Applicant's summary and conclusion
- Interpretation of results:
- other: classified as irritant within the CLP Regulation (EC 1272/2008)
- Conclusions:
- Irritant for rabbit eye.
- Executive summary:
The substance is tested for eye irritation according to OECD guideline 405.
Observation for effects was done 1, 24, 48 and 72 hours after start of exposure, up to 7 and 14 days. It was terminated after 14 days, because a clear tendency of a healing process was observed.
A yellow staining of the cornea and conjunctivae of treated eyes by pigment or coloring of test article was seen.
If necessary, prior to the first reading of the reactions, the eye was cleaned with disposable tissues to remove staining produced by test substance, so that reactions (erythema) were clearly visible.
Opacity of cornea was observed in two animals between 1 hour and 7 days and in one animal between 1 to 72 hours.
Mean value of the scores for each type of lesion, calculated for each animal separately, is the following:
1 male
Cornea opacity: 2
Iris: 0.67
Conjunctivae redness: 2
Conjuntivae chemosis: 2
1 male
Cornea opacity: 1.67
Iris: 0.67
Conjunctivae redness: 2
Conjuntivae chemosis: 2
1 female
Cornea opacity: 1
Iris: 0
Conjunctivae redness: 2
Conjuntivae chemosis: 1
Based on test results, the substance has to be considered as irritant to eyes.
As treated eyes were not rinsed, effects represent a worst-case situation.
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