Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 246-618-6 | CAS number: 25103-54-2
- 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
Endpoint summary
Administrative data
Description of key information
Based on results for analogous substances, zinc, bis(O,O-diisodecyl phosphorodithioato.kappa.s,.kappa.s’) is not a skin sensitiser.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with recognized guideline.
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
A read-across analogue approach can be performed for this endpoint because the source substance (CAS 28629-66-5) is structurally similar to the target substance. Both substances consist of substituted phosphorodithioic acid structures complexed with zinc, with differing alkyl chain lengths. Based on the similarity of structure, both substances are expected to have similar toxicity, or lack of toxicity, in mammalian systems.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source substance: Zinc bis(O,O-diisooctyl) bis(dithiophosphate) (CAS: 28629-66-5)
Target substance: Zinc, bis(O,O-diisodecyl phosphorodithioato.kappa.s,.kappa.s’) (CAS: 25103-54-2)
For full information on purity and impurities please see read-across justification report.
3. ANALOGUE APPROACH JUSTIFICATION
Source and target substances are structurally similar, differing only due to the length of the alkyl chains and degree of branching. Physico-chemical properties of the source and target substances follow a predictable pattern based on molecular size. Based on the similarity of structure, both substances are expected to have similar toxicity, or lack of toxicity, in mammalian systems. For a full justification of the read across approach please see attached read across justification report.
4. DATA MATRIX
See attached read across justification. - Reason / purpose for cross-reference:
- read-across source
- 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:
- During preparation of the original submission, reporting of an existing guinea pig maximisation test was considered more appropriate than sacrifice of further vertebrate animals in the Local Lymph Node Assay.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: no data.
- Age at study initiation: no data.
- Weight at study initiation: between 300 and 400 g.
- Housing: the animal 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 with elevated wire mesh flooring.
- Diet (e.g. ad libitum): Charles River Guinea Pig Formula was provided ad libitum.
- Water (e.g. ad libitum): tap water was provided ad libitum.
- Acclimation period: no data.
ENVIRONMENTAL CONDITIONS
- Temperature: 70 ± 2 oF
- Humidity (%): 45 ± 5
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle.
IN-LIFE DATES: From: 5 January 1982 To: 28 January 1982 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: white mineral oil
- Concentration / amount:
- 5% w/v
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: white mineral oil
- Concentration / amount:
- 5% w/v
- No. of animals per dose:
- 10 animals/dose
- Details on study design:
- RANGE FINDING TESTS: Unknown
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1 week following injection and 2 days (48hrs) 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: 5.0% w/v
- Evaluation (hr after challenge): 24 hr and 48 hr - Challenge controls:
- not included
- Positive control substance(s):
- not required
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% w/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% w/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test material does not appear to be a sensitizer in the albino guinea pig.
- Executive summary:
In a Modified Buehler Method test, 10 albino Guinea Pigs were treated with 5% w/v test substance, scores of zero in all test animals were obtained in the challenge phase 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
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with recognized guideline.
- 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:
- During preparation of the original submission, reporting of an existing guinea pig maximisation test was considered more appropriate than sacrifice of further vertebrate animals in the Local Lymph Node Assay.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: no data.
- Age at study initiation: no data.
- Weight at study initiation: between 300 and 400 g.
- Housing: the animal 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 with elevated wire mesh flooring.
- Diet (e.g. ad libitum): Charles River Guinea Pig Formula was provided ad libitum.
- Water (e.g. ad libitum): tap water was provided ad libitum.
- Acclimation period: no data.
ENVIRONMENTAL CONDITIONS
- Temperature: 70 ± 2 oF
- Humidity (%): 45 ± 5
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle.
IN-LIFE DATES: From: 5 January 1982 To: 28 January 1982 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: white mineral oil
- Concentration / amount:
- 5% w/v
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: white mineral oil
- Concentration / amount:
- 5% w/v
- No. of animals per dose:
- 10 animals/dose
- Details on study design:
- RANGE FINDING TESTS: Unknown
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1 week following injection and 2 days (48hrs) 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: 5.0% w/v
- Evaluation (hr after challenge): 24 hr and 48 hr - Challenge controls:
- not included
- Positive control substance(s):
- not required
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% w/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% w/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test material does not appear to be a sensitizer in the albino guinea pig.
- Executive summary:
In a Modified Buehler Method test, 10 albino Guinea Pigs were treated with 5% w/v test substance, scores of zero in all test animals were obtained in the challenge phase 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
- 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:
- During preparation of the original submission, reporting of an existing guinea pig maximisation test was considered more appropriate than sacrifice of further vertebrate animals in the newly adopted Local Lymph Node Assay.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: no data.
- Age at study initiation: no data.
- Weight at study initiation: between 300 and 400 g.
- Housing: the animal 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 with elevated wire mesh flooring.
- Diet (e.g. ad libitum): Charles River Guinea Pig Formula was provided ad libitum.
- Water (e.g. ad libitum): tap water was provided ad libitum.
- Acclimation period: no data.
ENVIRONMENTAL CONDITIONS
- Temperature: 70 ± 2 oF
- Humidity (%): 45 ± 5
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle.
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 injection and 2 days (48hrs) 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 hr and 48 hr - Challenge controls:
- Not included
- Positive control substance(s):
- not required
- Positive control results:
- n/a
- 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
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% w/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st 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
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% w/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test material does not appear to be a sensitizer in the albino guinea pig.
- 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:
- read-across from supporting substance (structural analogue or surrogate)
- 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.
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
A read-across analogue approach can be performed for this endpoint because the source substance (CAS 4259-15-8) is structurally similar to the target substance. Both substances consist of substituted phosphorodithioic acid structures complexed with zinc, with differing alkyl chain lengths. Based on the similarity of structure, both substances are expected to have similar toxicity, or lack of toxicity, in mammalian systems.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source substance: Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate) (CAS: 4259-15-8)
Target substance: Zinc, bis(O,O-diisodecyl phosphorodithioato.kappa.s,.kappa.s’) (CAS: 25103-54-2)
For full information on purity and impurities please see the attached read-across justification report.
3. ANALOGUE APPROACH JUSTIFICATION
Source and target substances are structurally similar, differing only due to the length of the alkyl chains and degree of branching. Physico-chemical properties of the source and target substances follow a predictable pattern based on molecular size. Based on the similarity of structure, both substances are expected to have similar toxicity, or lack of toxicity, in mammalian systems. For a full justification of the read across approach please see attached read across justification report.
4. DATA MATRIX
See attached read across justification.
- Reason / purpose for cross-reference:
- read-across source
- 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:
- During preparation of the original submission, reporting of an existing guinea pig maximisation test was considered more appropriate than sacrifice of further vertebrate animals in the newly adopted Local Lymph Node Assay.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: no data.
- Age at study initiation: no data.
- Weight at study initiation: between 300 and 400 g.
- Housing: the animal 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 with elevated wire mesh flooring.
- Diet (e.g. ad libitum): Charles River Guinea Pig Formula was provided ad libitum.
- Water (e.g. ad libitum): tap water was provided ad libitum.
- Acclimation period: no data.
ENVIRONMENTAL CONDITIONS
- Temperature: 70 ± 2 oF
- Humidity (%): 45 ± 5
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle.
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 injection and 2 days (48hrs) 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 hr and 48 hr - Challenge controls:
- Not included
- Positive control substance(s):
- not required
- Positive control results:
- n/a
- 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
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% w/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st 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
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% w/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test material does not appear to be a sensitizer in the albino guinea pig.
- 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
- Study period:
- 1997
- 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:
- During preparation of the original submission, reporting of an existing Buehler-type skin sensitisation test was considered more appropriate than sacrifice of further vertebrate animals in the newly adopted Local Lymph Node Assay.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague Dawley, Inc
- Age at study initiation:
- Weight at study initiation: 332-489 grams
- Housing: Housed individually in wire mesh suspension cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.8-26.1
- Humidity (%): 30-70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours
IN-LIFE DATES: From: To: - Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- Induction: 5% w/v
Challenge: 1% w/v - Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- Induction: 5% w/v
Challenge: 1% w/v - No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
Priary 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
- Test groups:
- Control group:
- Site: Left shoulder
- Frequency of applications: 6 to 7 days
- Duration:
- Concentrations:
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1 and 2 days (24 and 48 hours)
- Exposure period: 6 hours
- Test groups:
- Control group: 10 naive not previously exposed to test material
- Site:
- Concentrations:
- Evaluation (hr after challenge): 24 and 48 hours
OTHER: - Challenge controls:
- 10 naive not previously exposed to test material
- Positive control substance(s):
- yes
- Remarks:
- 1-Chloro-2,4,-Dinitrobenzene
- Positive control results:
- Postive for skin sensitization
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 3.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1%. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- 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:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Background irritation present
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
A read-across analogue approach can be performed for this endpoint because the source substance (CAS 4259-15-8) is structurally similar to the target substance. Both substances consist of substituted phosphorodithioic acid structures complexed with zinc, with differing alkyl chain lengths. Based on the similarity of structure, both substances are expected to have similar toxicity, or lack of toxicity, in mammalian systems.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source substance: Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate) (CAS: 4259-15-8)
Target substance: Zinc, bis(O,O-diisodecyl phosphorodithioato.kappa.s,.kappa.s’) (CAS: 25103-54-2)
For full information on purity and impurities please see the attached read-across justification report.
3. ANALOGUE APPROACH JUSTIFICATION
Source and target substances are structurally similar, differing only due to the length of the alkyl chains and degree of branching. Physico-chemical properties of the source and target substances follow a predictable pattern based on molecular size. Based on the similarity of structure, both substances are expected to have similar toxicity, or lack of toxicity, in mammalian systems. For a full justification of the read across approach please see attached read across justification report.
4. DATA MATRIX
See attached read across justification.
- Reason / purpose for cross-reference:
- read-across source
- 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:
- During preparation of the original submission, reporting of an existing Buehler-type skin sensitisation test was considered more appropriate than sacrifice of further vertebrate animals in the newly adopted Local Lymph Node Assay.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague Dawley, Inc
- Age at study initiation:
- Weight at study initiation: 332-489 grams
- Housing: Housed individually in wire mesh suspension cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.8-26.1
- Humidity (%): 30-70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours
IN-LIFE DATES: From: To: - Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- Induction: 5% w/v
Challenge: 1% w/v - Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- Induction: 5% w/v
Challenge: 1% w/v - No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
Priary 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
- Test groups:
- Control group:
- Site: Left shoulder
- Frequency of applications: 6 to 7 days
- Duration:
- Concentrations:
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1 and 2 days (24 and 48 hours)
- Exposure period: 6 hours
- Test groups:
- Control group: 10 naive not previously exposed to test material
- Site:
- Concentrations:
- Evaluation (hr after challenge): 24 and 48 hours
OTHER: - Challenge controls:
- 10 naive not previously exposed to test material
- Positive control substance(s):
- yes
- Remarks:
- 1-Chloro-2,4,-Dinitrobenzene
- Positive control results:
- Postive for skin sensitization
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 3.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1%. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- 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.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
For skin sensitisation, results are read across from two analogous ZDDP substances, CAS 4259 -15 -8 and CAS 28629 -66 -5. For full details of the read across approach, please see the attached read across justification. The results of the studies for the two read across substances are summarised below. All available data indicates that the substances are not skin sensitisers.
CAS 28629 -66 -5
In a key study using the Magnusson-Kligman Guinea pig maximization test, 20 Dunkin-Hartley strain albino Guinea pigs were treated with 5% w/v test substance for both the induction and challenge phases (Costello BA, 1982). Scores of zero in all test animals were obtained at all points examined. The test substance does not appear to be a sensitizer in the albino guinea pig.
In a supporting study using the Magnusson-Kligman Guinea pig maximization test, 20 Dunkin-Hartley strain albino Guinea pigs were treated with 5% w/v test substance for both the induction and challenge phases (Costello BA and Gilman MR, 1982). Scores of zero in all test animals were obtained at all points examined. The test substance does not appear to be a sensitizer in the albino guinea pig.
CAS 4259 -15 -8
In a Magnusson-Kilgman Guinea pig maximization test, 20 Dunkin-Hartley strain albino Guinea pigs were treated with 5% w/v test substance (Costello BA and Gilman MR, 1982). Scores of zero in all test animals were obtained at all points examined. The test substance does not appear to be a sensitizer in the albino guinea pig. In accordance to Directive 67/548/EEC and EU CLP (Regulation (EC) No. 1272/2008), this substance does not meet the criteria for classification as a skin sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
no data available
Migrated from Short description of key information:
no data available
Justification for classification or non-classification
In accordance with EU CLP (Regulation (EC) No. 1272/2008), this substance does not meet the criteria for classification as a skin sensitizer.
No data are available for respiratory sensitization.
The substance is therefore not classifiable for this endpoint in accordance to the CLP Regulation (EC) No 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.