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EC number: 610-992-2 | CAS number: 53378-52-2
- 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:
- April 10, 1991 - April 30, 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Limited details on test material and environmental conditions. No controls were avalable as both eyes were dosed with the test substance. Observations were not performed until 21 days but only until 7 days at which irreversibility of the cornea (1 animal) and the conjunctiva (2/3 animals) was observed in the unwashed eyes. In the washed eyes, irreversibility of the cornea (2/3 animals) and conjunctiva (redness) (all animals) was observed until day 7.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 10, 1991 - April 30, 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Limited details on test material and environmental conditions.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Limited details on test material and environmental conditions.
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): CT 473-91
- Name: Sodium diisobutyl monothiophoshate
- CAS: 53378-52-2
- Molecular formula: C8H18O3PS.Na
- Molecular weight: 248.26
- Substance type: Amber liquid
- Physical state: Liquid
- Lot/batch No.: SPS-17220
- Storage condition of test material: Store at room temperature in the dark - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: Ace animals
- Age at study initiation: no data
- Weight at study initiation: 2.5 - 2.6 kg
- Housing: Animals were housed individually in suspended cages.
- Diet: Free access to fresh purina chow (diet #5321)
- Water: Free access to water.
- Acclimation period: At least 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL/site - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Skin reactions were evaluated at 1, 24, 48 and 72 hours after patch removal.
- Number of animals:
- 3
- Details on study design:
- STUDY DESIGN
The test article was applied to one abraded and one intact site on the cilpped back of each of three rabbits. The treated sites were covered with two 2.5 cm square gauze patches which were secured with adhesive tape. The torso was wrapped with plastic and secured with adhesive tape.
TEST SUBSTANCE PREPARATION
Used as received. 0.5 mL/site, total dose of 0.1 mL/rabbit.
TEST SITE
Prior to application of the test substance, the back and sides of each animal were clipped free of hair. The left side of each animal was abraded with a bent-tip needle. Three abrasions, approximately 2-3 cm apart, extending the length of the exposure site were made. The abrasions were sufficiently deep to penetrate the stratum corneum but not deep enough to produce bleeding.
REMOVAL OF TEST SUBSTANCE
Four hours after the application, the residual test substance was wiped off prior to dermal observations.
OBSERVATIONS
- Mortality/Viability/Toxicity: The general health of the animals was monitored at each dermal irritation observation.
- Body Weight: Body weights were recorded pretest.
- Necropsy: No data.
- Irritation: The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after patch removal. The irritation scores and a description of all other (local) effects were recorded.
SCORING SYSTEM:
The irritation was assessed according to the numerical scoring system according to OECD 404. - Irritation parameter:
- erythema score
- Remarks:
- (Intact skin)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- erythema score
- Remarks:
- (Intact skin)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- (Intact skin)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- (Abraded skin)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- erythema score
- Remarks:
- (Abraded skin)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- (Abraded skin)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- (Intact skin)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- (Intact skin)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- (Intact skin)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- (Abraded skin)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- (Abraded skin)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- (Abraded skin)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Erythema, slight at 1 hour after patch removal, was absent to slight at 24 hours and absent at 48 and 72 hours both in intact and abraded skin. There was no edema noted at any time point.
- Other effects:
- There were no abnormal systemic signs noted during the observation period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an skin irritation study with CT-473-91 in rabbits, performed equivalent or similar to OECD 404 test guidelines, no irritation was observed, both in intact and abraded skin.
- Executive summary:
Dermal irritation was tested by three rabbits who were exposed to CT-473-91, a 50% solution in water, for 4 hours using a occlusive dressing, equivalent or similar to OECD 404 test guideline and according to GLP principles.
Erythema, slight at 1 hour after patch removal, was absent to slight at 24 hours and absent at 48 and 72 hours, both in intact and abraded skin. There was no edema noted at any time point. There were no abnormal systemic signs noted during the observation period.
Based on the results, CT-473-91, a 50% solution in water, is not considered irritating to both intact and abraded skin and no classification for dermal irritation is needed according to EC regulation 1272/2008.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Limited details on test material and environmental conditions. No controls were avalable as both eyes were dosed with the test substance. Observations were not performed until 21 days but only until 7 days.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium O,O-diisobutyl phosphorothioate
- EC Number:
- 610-992-2
- Cas Number:
- 53378-52-2
- Molecular formula:
- C8 H18 O3 P S . Na
- IUPAC Name:
- Sodium O,O-diisobutyl phosphorothioate
- Test material form:
- other: grease-like solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): CT 473-91
- Name: Sodium diisobutyl monothiophoshate
- CAS: 53378-52-2
- Molecular formula: C8H18O3PS.Na
- Molecular weight: 248.26
- Substance type: Amber liquid
- Physical state: Liquid
- Lot/batch No.: SPS-17220
- Storage condition of test material: Store at room temperature in the dark
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: Ace animals
- Age at study initiation: no data
- Weight at study initiation: 2.5 - 2.6 kg
- Housing: Animals were housed individually in suspended cages.
- Diet: Free access to fresh purina chow (diet #5321)
- Water: Free access to water.
- Acclimation period: At least 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- Single instillation on Day 1.
- Observation period (in vivo):
- The eyes of each animal were examined approximately 1, 24, 48 and 72 hours and 7 days after instillation of the test substance
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- STUDY DESIGN
Initially, both eyes of two rabbits were dosed. Due to vocalization noted in two animals post dose, the third animal was not dosed pending consultation with the sponsor. The day following initial administration, the third rabbit was dosed based on the sponsor's instructions.
TREATMENT
The test substance was placed by syringe or syringe-type applicator into the conjunctival sac which was formed by gently pulling the lower eyelid away from the eye. After instillation, the lids were held together briefly to insure adequate distribution of the test substance.
REMOVAL OF TEST SUBSTANCE
-Washing: Twenty to thirty seconds after instillation of the test substance, the left eye of each rabbit was flushed for one minute with lukewarm water. The right eye of each animal remained unwashed.
OBSERVATIONS
- Mortality/Viability/Toxicity: The general health of the animals was monitored at each observation period.
- Body Weight: Body weights were recorded pretest.
- Necropsy: No data.
- Irritation:
The eyes of each animal were examined approximately 1, 24, 48 and 72 hours and 7 days after instillation of the test substance.
The irritation scores and a description of all other (local) effects were recorded. The irritation was assessed according to OECD 405.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- (unwashed right eye)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: vocalization post dose
- Irritation parameter:
- cornea opacity score
- Remarks:
- (unwashed right eye)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: vocalization post dose
- Irritation parameter:
- cornea opacity score
- Remarks:
- (unwashed right eye)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs.
- Remarks on result:
- other: vocalization post dose
- Irritation parameter:
- cornea opacity score
- Remarks:
- (washed left eye)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- (washed left eye)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- (washed left eye)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Remarks:
- (unwashed right eye)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: vocalization post dose
- Irritation parameter:
- iris score
- Remarks:
- (unwashed right eye)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: vocalization post dose and on day 7 an iris score of 1 was observed
- Irritation parameter:
- iris score
- Remarks:
- (unwashed right eye)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hrs.
- Remarks on result:
- other: vocalization post dose
- Irritation parameter:
- iris score
- Remarks:
- (washed left eye)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Remarks:
- (washed left eye)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Remarks:
- (washed left eye)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (unwashed right eye)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: vocalization post dose
- Irritation parameter:
- conjunctivae score
- Remarks:
- (unwashed right eye)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: vocalization post dose
- Irritation parameter:
- conjunctivae score
- Remarks:
- (unwashed right eye)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: vocalization post dose
- Irritation parameter:
- conjunctivae score
- Remarks:
- (washed left eye)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (washed left eye)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (washed left eye)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Remarks:
- (unwashed right eye)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hrs.
- Remarks on result:
- other: vocalization post dose
- Irritation parameter:
- chemosis score
- Remarks:
- (unwashed right eye)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: vocalization post dose
- Irritation parameter:
- chemosis score
- Remarks:
- (unwashed right eye)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: vocalization post dose
- Irritation parameter:
- chemosis score
- Remarks:
- (washed left eye)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Remarks:
- (washed left eye)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Remarks:
- (washed left eye)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Unwashed eyes:
Corneal opacity, noted in 2/3 animals, persisted to day 7 in one eye. Iritis was noted in 2/3 animals. Moderate to severe conjunctival irritation, noted in all animals, persisted to day 7 in one animal, improved to slight in another and cleared completely in the third animal.
Washed eyes:
Corneal opacity, noted in all animals, persisted to day 7 in 2/3 animals. Iritis, noted in all animals cleared by day 7. Moderate to severe conjuctival irritation, noted in all animals, persisted to day 7 in two animals and improved to slight in one animal. - Other effects:
- Vocalization post dose was observed in all animals.
Any other information on results incl. tables
Tables with results see the attached background material.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In an eye irritation study with CT-473-91 in rabbits, performed equivalent or similar to OECD 405 test guideline and GLP principles, irreversible effects on the eye were observed during the 7 day observation period.
- Executive summary:
Eye irritation properties of CT-473 -91, a 50% solution in water, was tested in both eyes of three rabbits, equivalent or similar to OECD 405 test guideline and GLP principles.
No controls were avalable as both eyes were dosed with the test substance. The right eye were unwashed and the left eye was washed twenty to thirty seconds after instillations of the test substance. Vocalization post dose was observed in all animals.
Observations were performed until only 7 days at which irreversibility of the cornea (1 animal) and the conjunctiva (2/3 animals) was observed in the unwashed eyes. In the washed eyes, irreversibility of the cornea (2/3 animals) and conjunctiva (redness) (all animals) was observed until day 7.
Based on the observed irreversibility effects in both the washed and unwashed eyes during the observation period, CT-473 -91, a 50% solution in water, needs to be classified as serious eye damage, category 1 and labelled with H318: Causes serious eye damage, according to EC regulation 1272/2008.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.