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EC number: 605-708-9 | CAS number: 174125-93-0
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- Short-term toxicity to fish
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- Toxicological Summary
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- Irritation / corrosion
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Endpoint summary
Administrative data
Description of key information
Skin irritation: 3 albino rabbits, undiluted application onto clipped skin, 0.5 ml, 4h exposure, OECD 404, GLP: not irritating acc. Regulation 1272/2008
Eye irritation: 3 albino rabbits, undiluted application into the eye, 0.1 ml, no wash-out, OECD 405, GLP: not irritating acc. Regulation 1272/2008
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin 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:
- 1995-10-31 - 1995-11-10 (experimental phase)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- OECD Guide!ine for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion". Adopted: 17 July 1992.
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: approx. 10 to 11 weeks
- Weight at study initiation: 2.3 to 2.5 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 skin irritation studies and is the animal recommended in the test guideline. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4h exposure
- Observation period:
- 11 days
- Number of animals:
- Three healthy adult rabbits
- Details on study design:
- TEST SITE
- Area of exposure: Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately 100 mm x 100 mm.
- Type of wrap if used: A 0.5 ml amount of the test substance was applied under a 25 mm x 25 mm gauze pad to one intact skin site on each animal.
Each treatment site was covered with "Elastoplast" elastic adhesive dressing for four hours. The animals were not restrained during the exposure period and were returned to their cages immediately after treatment.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (30° to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: 4h
OBSERVATION TIME POINTS
Clinical signs: All animals were observed daily for signs of ill health or toxicity.
Dermal responses: Examination of the treated skin was made on Day 1 (ie approximately 60 minutes after removal of the dressings) and on Days 2, 3 and 4 (equivalent to 24, 48 and 72 hours after exposure). Additional observations were made on Days 5 through to 11.
SCORING SYSTEM:
Local dermal irritation was assessed using the prescribed numerical system:
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) preventing erythema reading 4
Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4
Any other lesion not covered by this scoring system, was described. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: day 11
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: day 11
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: day 11
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.56
- Max. score:
- 2
- Reversibility:
- fully reversible within: day 11
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: day 3
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: day 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: day 4
- Irritant / corrosive response data:
- Very slight to well-defined erythema with or without very slight to slight oedema was seen in all three animals. These reactions gradually ameliorated but slight erythema together with dryness and sloughing of the stratum corneum was still present in all three animals from Day 8. The skins were all normal on Day 11.
- Other effects:
- - Other adverse local effects: Dryness and sloughing
- Other adverse systemic effects: none stated - Interpretation of results:
- GHS criteria not met
- Remarks:
- EU implementation
- Conclusions:
- The study was conducted under GLP according to OECD TG 404 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: 1.0 / 1.67 / 2.0 (erythema score) and 0.33 / 0.67 / 0.0 (edema score). These reactions gradually ameliorated but slight erythema together with dryness and sloughing of the stratum corneum was still present in all three animals from Day 8, all effects were fully reversible on day 11.
According to Regulation (EC) 1272/2008 table 3.2.2, a substance must be classified as Irritating to skin (Category 2), if the following criteria are met:
1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or
(2) Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or
(3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.
Hence, the above mentioned criteria for classification according to Regulation (EC) 1272/2008 as skin irritant are not met. - Executive summary:
A study was performed to assess the skin irritation potential of Bis(O,O-2-ethylhexyl-thiophosphoryl)polysulfide to the rabbit. The method followed was that described in: OECD Guideline for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion". Adopted: 17 July 1992.
Three rabbits were each administered a single dermal dose of 0.5 ml of the test substance and observed for eleven days.
A single semi-occlusive application of the test item to intact rabbit skin for four hours elicited well-defined dermal irritation. All reactions had resolved by Day 11. Testing revealed the following scores from gradings at 24, 48 and 72 hours in the three individual animals: 1.0 / 1.67 / 2.0 (erythema score) and 0.33 / 0.67 / 0.0 (edema score).
The substance does not need to be classified as skin irritant according to Regulation (EC) 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- 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
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature - 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. - 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. - 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.
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
According to Regulation (EC) 1272/2008 table 3.2.2, a substance must be classified as Irritating to skin (Category 2), if the following criteria are met:
1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or
(2) Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or
(3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.
A single semi-occlusive application of the test item to intact rabbit skin for four hours elicited well-defined dermal irritation. All reactions had resolved by Day 11. Testing revealed the following scores from gradings at 24, 48 and 72 hours in the three individual animals: 1.0 / 1.67 / 2.0 (erythema score) and 0.33 / 0.67 / 0.0 (edema score).
Hence, the above mentioned criteria for classification according to Regulation (EC) 1272/2008 as skin irritant are not met.
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.
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.
Hence, the above mentioned criteria for classification according to Regulation (EC) 1272/2008 as eye irritant are not met.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.