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EC number: 821-762-8 | CAS number: 4563-56-8
- 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
Buehler test: not sensitising
RA from CAS 4259-15-8
Guinea pig maximisation test: not sensitising
RA from CAS 4259-15-8
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 Dec 1981 - 14 Jan 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study. Restriction due to missing details in study report. Missing details did not affect ability to evaluate effect of test substance on skin sensitisation.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: between 300 and 400 g
- Housing: the animals were housed and maintained in compliance with the Animal Welfare Act 9 CFR part 3. Five guinea pigs per cage were housed in stainless steel cages with elevated wire mesh flooring.
- Diet: Charles River Guinea Pig Formula was provided ad libitum.
- Water: tap water was provided ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature: 70 ± 2 °F
- Humidity (%): 45 ± 5
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 28 December 1981 To: 14 January 1982 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: white mineral oil
- Concentration / amount:
- 5.0 % w/v
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: white mineral oil
- Concentration / amount:
- 5.0 % w/v
- No. of animals per dose:
- 20 animals / dose
- Details on study design:
- RANGE FINDING TESTS: Unknown
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1 week following intradermal injection and 2 days (48 h) after dermal application.
- Test groups: 1 group of 20 male animals.
- Control group: Not included.
- Site: skin over the shoulders.
- Frequency of applications: For induction stage: intradermal injections were made once at 3 pairs of sites simultaneously, 7 days later followed by dermal application of test material. Then the animals were allowed to rest for 2 weeks.
- Duration: total of 3 week time period.
- Concentrations: 5% w/v
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 21 h
- Test groups: 1 group of 20 male animals.
- Control group: Not included.
- Site: skin over the shoulders.
- Concentrations: 5% w/v
- Evaluation (hr after challenge): 24 h and 48 h - Challenge controls:
- Not included
- Positive control substance(s):
- not required
- Positive control results:
- n/a
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- CLP: not classified
- Executive summary:
In a Magnusson-Kligman Guinea Pig maximization test, 20 Dunkin-Hartley strain albino Guinea Pigs were treated with 5.0% w/v test substance, Scores of zero in all test animals were obtained at all time points examined. The test material does not appear to be a sensitizer in the albino guinea pig.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Background irritation present
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague Dawley, Inc
- Weight at study initiation: 332-489 grams
- Housing: Housed individually in wire mesh suspension cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.8-26.1
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- Induction: 5% w/v
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- Challenge: 1% w/v
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
Primary Irritation after 6 hour patch aplication of test material in mineral oil at following concentrations:
Undiluted, 50, 25, 10, 5, 2.5, 1, 0.5 % w/v
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Site: Left shoulder
- Frequency of applications: 6 to 7 days
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1 and 2 days (24 and 48 hours)
- Exposure period: 6 hours
- Control group: 10 naive not previously exposed to test material
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- 10 naive not previously exposed to test material
- Positive control substance(s):
- yes
- Remarks:
- 1-Chloro-2,4,-Dinitrobenzene
- Positive control results:
- Positive for skin sensitization
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- CLP: not classified
Referenceopen allclose all
The irritation in 3/20 animals in the challenge phase scored after 24 hours did not persist to 48 hours, indicating an irritation response rather than a skin sensitization response.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Justification for read-across
There are no reliable data available on skin sensitisation toxicitywith Phosphorodithioic acid, O,O-di-dodecyl-esters, zinc salts, neutral and basic (CAS 4563-56-8). Read-across from an appropriate substance Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate) (CAS4259-15-8) is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. in order to fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VII, 8.3. Common functional groups, structural similarities and comparable toxicological properties of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).
GPMT
A Guinea pig maximisation test was performed with Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate) (CAS 4259-15-8) similar to the OECD Guideline 406 and under GLP conditions (Key, 1982). In the main study, 20 male Dunkin-Hartley guinea pigs were treated with the test substance at 5% (w/v) for intra- and epidermal induction on days 1 and 7, respectively. The dressing for epidermal induction was kept in place for 48 h. 14 days after the epidermal induction, epidermal challenge was performed with the test material at 5% (w/v). Positive control and negative controls were not included in the conducted study. 24 and 48 h after the challenge treatment skin examination revealed no skin reactions in the test groups. Under the conditions of the conducted study, the test substance was considered to be not skin sensitising.
Buehler test
A Buehler test was performed with Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate) (CAS 4259-15-8) similar to the OECD Guideline 406 and under GLP conditions (Key, 1997). A range-finding study was conducted. In the main study, 20 male and female Hartley guinea pigs were treated three times with the test substance at 5% (w/v) for 6 h for epidermal induction. Thereafter, epidermal challenge was performed with the test material at 1% (w/v) after 24 and 48 h, respectively. 1-Chloro-2,4,-Dinitrobenzene was used as positive control and 10 naive guinea pigs which were not previously exposed to the test material was used as challenge control. In the treatment group 3/20 animals showed a positive result, which did not persist to 48 h, indicating an irritation response rather than a skin sensitising response. In the control group 1/10 animals showed a positive response after 24 h, which did not persist to 48 h. Positive control showed a positive result (not further specified). Under the conditions of the conducted study, the test substance was considered to be not skin sensitising.
A second Buehler test with the source substance Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate) (CAS 4259-15-8) was available. In this study, there was a high level of background irritation present throughout the study (Supporting, 1986). Therefore the study was considered to be not reliable.
In conclusion, based on the results with the source substance, the target substance is not considered to exhibit a skin sensitising potential.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Applying the RA-approach, the available data on skin sensitisation do not meet the criteria for classification according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.
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