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EC number: 248-324-3 | CAS number: 27206-35-5
- 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
Endpoint summary
Administrative data
Description of key information
Skin irritation: In vivo dermal irritation study, rabbit (New Zealand White), 4h exposure, semiocclusive, SPS, OECD 404, GLP: not irritating
Skin irritation: In vivo dermal irritation study, rabbit (New Zealand White), 24h exposure, occlusive, MPS, OECD 404, GLP: not irritating
Eye irritation: In vivo eye irritation study, rabbit (New Zealand White), unchanged, no wash-out, SPS, OECD 405, GLP: mild irritant (modified Kay and Calandra classification), not irritating (EU, 92/69/EEC)
Eye irritation: In vivo eye irritation study, rabbit (New Zealand White), unchanged, MPS, OECD 405, GLP: not irritating (EU)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 June - 22 June 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (The Department of Health of the Government of the United Kingdom)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd. , Moston , Sandbach , Chesire , UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.62 - 3.05 kg
- Housing: animals were individually housed in suspended metal cages
- Diet (e.g. ad libitum): STANRAB SQC Rabbit Diet (Special Diets Services Ltd. , Witham , Essex , UK)
- Water (e.g. ad libitum): mains drinking water , ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 20
- Humidity (%): 60 - 62
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- (the substance was moistened with 0.5 ml distilled water)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): the substance was moistened with 0.5 ml distilled water - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: the test site was covered with a 2.05 x 2.5 cm cotton gauze patch that was held in place with a strip of surgical adhesive tape (BLENDERM : approximate size 2.5 cm x 4.0 cm) . The trunk of the rabbits was then wrapped in an elasticated corset (TUBIGRIP) .
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test material was removed by gentle swabbing with cotton wool soaked in distilled water .
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system . The test sites were examined 1 , 24 , 48 and 72 hours after the exposure ended . - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (of all 3 animals)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (of all 3 animals)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Very slightly erythema was noted at all treated skin sites one hour after patch removal . All treated skin sites appeared normal at the 24-hour observation .
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The study was performed according to the OECD TG404 without deviations and therefore considered to be of the highest quality (reliability Klimisch 1). The validity criteria of the test system are fulfilled. The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
- Executive summary:
A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 17 July 1992) and Method B4 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC). A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema. All treatment sites appeared normal at the 24-hour observation. The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations. No symbol and risk phrase are required.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 24 June to 29 June 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- 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
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (The Department of Health of the Government of the United Kingdom)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd. , Moston , Sandbach , Chesire , UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.6-3.2 kg
- Housing: animals were individually housed in suspended metal cages
- Diet (e.g. ad libitum): STANRAB SQC Rabbit Diet (Special Diets Services Ltd. , Witham , Essex , UK) , ad libitum
- Water (e.g. ad libitum): mains drinking water , ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-20
- Humidity (%): 58-69
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml , weighing approximately 81 mg - Observation period (in vivo):
- 72 h
Reading time points : 1 , 24 , 48 and 72 h - Number of animals or in vitro replicates:
- 3
- Details on study design:
- Immediately before the start of the test , both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope . Animals showing evidence of ocular lesions were rejected and replaced .
One animal was treated . After consideration of the ocular responses in the first treated animal , two additional animals were treated . In order to minimise pain on application of the test material , one drop of local anaesthetic ("Ophthaine" , 0.5% proxymetacaine hydrochloride , E R Squibb & Sons Limited , Hounslow , Middlesex , UK) was instilled into both eyes of these animals 1 to 2 minutes before treatment .
The test substance was placed into the conjunctival sac of the right eye , formed gently pulling the lower lid away from the eyeball . The upper and lower eyelids were held together for about one second immediately after application , to prevent loss of the test material , and then released . The left eye remained untreated and was used for control purposes . Immediatelly after administration of the test material , an assessment of the initial pain reaction was made . Assessment of ocular damage/irritation was made approximately 1 hour and 24 , 48 and 72 hours after treatment .
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eye was not washed after treatment
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: opthalmoscope - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.25
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.25
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Remarks:
- Chemosis
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Remarks:
- Chemosis
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Remarks:
- Chemosis
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.25
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- animal #1
- Time point:
- other: mean over 1,24,48,72 h
- Score:
- 0.75
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- animal #2
- Time point:
- other: mean over 1,24,48,72 h
- Score:
- 0.25
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- animal #3
- Time point:
- other: mean over 1,24,48,72 h
- Score:
- 0.25
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- Minimal to moderate conjunctival irritation was noted in all treated eyes 1 and 24 hours after treatment . Minimal conjunctival irritation was noted in two treated eyes at the 48-hour observation .
- Other effects:
- No other evidence of eye irritation was noted during the study .
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The study was performed according to the OECD TG405 without deviations and therefore considered to be of the highest quality (reliability Klimisch 1). The validity criteria of the test system are fulfilled. The test material produced a maximum mean score of 9.3 and was classified as a MILD IRRITANT (CLASS 4 ON A 1 TO 8 SCALE) to the rabbit eye according to a modified Kay and Calandra classification system .
The test material did not produce positive criteria in any rabbit according to the EU labelling regulations . No symbol and risk phrase are therefore required . - Executive summary:
A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 February 1987) and Method B5 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC). A single application of the test material to the non-irrigated eye of three rabbits produced minimal to moderate conjunctival irritation. The test material produced a maximum group mean score of 9.3 and was classified as a mild irritant (Class 4 an a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The test material did not meet the criteria for classification as irritant according to EU labelling regulations. No symbol and risk phrase are required.
Reference
Table 1 : Individual total scores and group scores for ocular irritation
|
Table 2 : Individual and mean scores for cornea , iris and conjunctivae required for EU labelling regulations
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
For both endpoints skin and eye irritation, there are each an in vivo Klimisch 1 GLP OECD guideline study on SPS and a supporting in vivo GLP OECD guideline study on MPS (1-Propanesulfonic acid, 3-mercapto-, monosodium salt), which is an acceptable read-across substance, available. All available studies gave consistent results, i.e. that SPS does not need to be classified as skin or eye irritant according to EU classification and labelling criteria. The available database is of high quality, no indication is given that the available results are not relevant for humans, hence, no data gaps were identified and no additional testing is required, It can be safely concluded that disodium 3,3'-dithiobis[propanesulphonate] (SPS) is not a skin or eye irritant in humans, no hazard was identified.
Justification for selection of skin
irritation / corrosion endpoint:
Klimisch 1 key study on SPS itself.
Justification for selection of eye irritation endpoint:
Klimisch 1 key study on SPS itself.
Justification for classification or non-classification
All available data gave consistent results that the criteria for classification as skin or eye irritant according to Directive 67/548/EEC and amendatory directives are not met. These criteria are similar to the recent ones of Regulation (EC) 1272/2008, hence, SPS does not need to be classified as skin or eye irritant, neither according to Directive 67/548/EEC nor Regulation (EC) 1272/2008.
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