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EC number: 434-280-4 | 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Octadec-9-en-1-yl ammonium mono and di-butylphosphate
- Molecular formula:
- C22H48NO4P - C26H56NO4P
- IUPAC Name:
- Octadec-9-en-1-yl ammonium mono and di-butylphosphate
- Reference substance name:
- Octadec-9-en-1-yl ammonium di-n-hexyl phosphorodithioate
- Molecular formula:
- C30H64NO2PS2
- IUPAC Name:
- Octadec-9-en-1-yl ammonium di-n-hexyl phosphorodithioate
- Test material form:
- liquid: viscous
- Details on test material:
- Material is a yellow viscous liquid
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Number of animals: 3 animals of one sex
Age and body weight: Animals used within the study were at least 6 weeks old and body weights were at least 1 .0 kg.
Identification: earmark
Conditions
A controlled environment was maintained in the room with optimal conditions considered as being approximately 1 5 air changes per hour, a temperature of 21 ±3°C, a relative humidity of 30-70% and 12 hours artificial fluorescent light and 12 hours dark per day.
Accommodation
Individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56x44x37.5 cm). Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
Diet
Standard laboratory rabbit diet {Teklad Global Rabbit Diet, code 2030, Harlan, Blackthorn, England) approx. 1 00 g. per day. Certificates of analysis were examined and retained in the NOTOX archives. In addition, hay (BMI, Helmond, the Netherlands) was provided twice a week.
Water
Free access to tap-water. Certificates of quarterly analysis were examined and retained in the NOTOX archives.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- Sinngle application
- Observation period (in vivo):
- Single application. Total observation period of 14 days post instillation.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Since marked effects were considered possible and at request of the sponsor this eye irritation study was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner 1 4 days later, after considering the degree of eye irritation observed in the first animal.
A health inspection was performed prior to commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the eyes, which were free from any abnormality.
Each animal was treated by instillation of 0 .1 ml of the test substance in the conjunctiva! sac of one of the eyes 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.
Immediately after the 24 hour observation, a solution of 2% fluorescein in water (adjusted to pH 7 .0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. When considered necessary, this procedure was repeated to assess recovery. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 316 - Sentinel
- Time point:
- other: Mean of scores at 24, 48 & 72 hrs
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- Animal # 355
- Time point:
- other: Mean of scores at 24, 48 & 72 hrs
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- Animals # 356
- Time point:
- other: Mean of scores at 24, 48 & 72 hrs
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 316 - Sentinel
- Time point:
- other: Mean of scores at 24, 48 & 72 hrs
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- Animal #355
- Time point:
- other: Mean of scores at 24, 48 & 72 hrs
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- Animal #356
- Time point:
- other: Mean of scores at 24, 48 & 72 hrs
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: Effects noted at 1 hr, but not observed at 24 hrs and subsequent to that.
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- 316 - Sentinel
- Time point:
- other: Mean of scores at 24, 48 & 72 hrs
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- Animal #355
- Time point:
- other: Mean of scores at 24, 48 & 72 hrs
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- Animal #356
- Time point:
- other: Mean of scores at 24, 48 & 72 hrs
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 316 - Sentinel
- Time point:
- other: Mean of scores at 24, 48 & 72 hrs
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Animal #355
- Time point:
- other: Mean of scores at 24, 48 & 72 hrs
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Animal #356
- Time point:
- other: Mean of scores at 24, 48 & 72 hrs
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritant / corrosive response data:
- Irritation
Instillation of 0 .1 ml of the test substance into one eye of each of three rabbits resulted in effects on the cornea, iris and conjunctivae.
Corneal injury was seen as opacity (maximum grade 1 ) and epithelial damage (maximum 25 or 50 % of the corneal area). The corneal injury had resolved within 72 hours in two animals and within 7 days in the other animal.
lridial irritation (grade 1 ) was observed which had resolved within 24 or 72 hours or within 7 days.
Irritation of the conjunctivae was seen as redness, chemosis and discharge, which had completely resolved within 1 4 days in all animals.
Corrosion
There was no evidence of ocular corrosion. - Other effects:
- Colouration I Remnants
No staining of (peri) ocular tissues by the test substance was observed.
oxicity I Mortality
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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