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EC number: 605-708-9 | CAS number: 174125-93-0
- 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
- Remarks:
- study was conducted prior to the implementation of REACH and adoption of suitable in vitro methods
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-11-06 - 1995-11-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- OECD Guideline for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion". Adopted: 24 February 1987.
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- bis(O,O-2-ethylhexyl-thiophosphoryl)polysulfide
- EC Number:
- 605-708-9
- Cas Number:
- 174125-93-0
- Molecular formula:
- n.a.
- IUPAC Name:
- bis(O,O-2-ethylhexyl-thiophosphoryl)polysulfide
- Test material form:
- liquid
- Remarks:
- Orange/brown
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire. England
- Age at study initiation: approximately 11 to 13 weeks
- Weight at study initiation: 2.6 to 3.1 kg
- Housing: The rabbits were selected without conscious bias for the study. They were housed individually in metal cages with perforated floors.
- Diet (e.g. ad libitum): A standard laboratory diet SDS Stanrab (P) Rabbit Diet was provided ad libitum.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: All rabbits were acclimatised to the experimental environment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Animal room temperature was maintained at approximately 19°C.
- Humidity (%): Relative humidity was maintained at 30 ± 70%.
These environmental parameters were recorded daily.
- Air changes (per hr): Air exchange was maintained at approximately 19 air changes per hour.
- Photoperiod (hrs dark / hrs light): Lighting was controlled by means of a time switch to give 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period.
The albino rabbit was chosen as it has been shown to be a suitable model for eye irritation studies and is the animal recommended in the test guideline.
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
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- Single instillation into the lower everted lid of one eye, no wash-out
- Observation period (in vivo):
- 1 week
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no wash-out
SCORING SYSTEM:
Ocular irritation was assessed using the prescribed numerical system:
Cornea
Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Nacreous areas, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible through the opacity 4
Area of cornea involved
One quarter (or less) but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4
Iris
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross destruction (any or all of these) 2
Conjunctivae
Redness (refers to the most severe reading of palpebral and bulbar conjunctivae, as compared to the control eye)
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red 3
Chemosis (lids and/or nictating membranes)
No swelling 0
Any swelling above normal (includes nictating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half-closed 3
Swelling with lids more than half-closed 4
TOOL USED TO ASSESS SCORE: Observation of the eyes was aided by the use of a handheld light.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- individual values: 0.0 / 0.0 / 0.0
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- individual values: 0.0 / 0.0 / 0.0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- 24/48/72 h
- Score:
- 0.89
- Max. score:
- 2
- Reversibility:
- fully reversible within: Day 4
- Remarks on result:
- other:
- Remarks:
- individual values: 2.0 / 0.33 / 0.33
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- individual values: 0.0 / 0.0 / 0.0
- Irritant / corrosive response data:
- OCULAR RESPONSES
No corneal damage or iridial inflammation was observed.
A diffuse crimson colouration of the conjunctivae was seen in all three animals.
The eyes were normal two and four days after instillation. - Other effects:
- - Lesions and clinical observations: There were no signs of toxicity or ill health in any rabbit during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- EU implementation
- Conclusions:
- The study was conducted under GLP according to OECD TG 405 on the registered substance itself. The method is to be considered scientifically reasonable with no deficiencies. Hence, the results can be considered as sufficiently reliable to assess the irritating properties of the test item.
Testing revealed the following scores from gradings at 24, 48 and 72 hours in the three individual animals: 0.0 / 0.0 / 0.0 (cornea opacity score), 0.0 / 0.0 / 0.0 (iris score), 2.0 / 0.33 / 0.33 (conjunctivae score (redness)), 0.0 / 0.0 / 0.0 (chemosis score). The eyes were normal two and four days after instillation.
According to Regulation (EC) 1272/2008 table 3.3.2, a substance must be classified as Irritating to eyes (Category 2), if, when applied to the eye of an animal, a substance produces:
— at least in 2 of 3 tested animals, a positive response of:
— corneal opacity ≥ 1 and/or
— iritis ≥ 1, and/or
— conjunctival redness ≥ 2 and/or
— conjunctival oedema (chemosis) ≥ 2
— calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days
Hence, the above mentioned criteria for classification according to Regulation (EC) 1272/2008 as eye irritant are not met. - Executive summary:
A study was performed to assess the eye irritation potential of Bis(O,O-2-ethylhexy3-thiophosphoryl)polysulfide to the rabbit. The method followed was that described in: OECD Guideline for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion". Adopted: 24 February 1987.
Three rabbits were each administered a single ocular dose of 0.1 ml of the test substance and observed for seven days after instillation.
A single instillation of the test item into the eye of the rabbit elicited transient well-defined conjunctival irritation only. All reactions had resolved two or four days after instillation. Scores of the three individual animals were 0.0 / 0.0 / 0.0 (cornea opacity score), 0.0 / 0.0 / 0.0 (iris score), 2.0 / 0.33 / 0.33 (conjunctivae score (redness)), 0.0 / 0.0 / 0.0 (chemosis score).
The substance does not need to be classified as eye irritant according to Regulation (EC) 1272/2008.
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