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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 04, 1998 - September 05, 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Also according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- (1996)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was performed before the LLNA was existed as an OECD guideline method.
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): AERO® 6697 Promoter
- Name: Sodium diisobutyl monothiophoshate
- CAS: 53378-52-2
- Molecular formula: C8H18O3PS.Na
- Molecular weight: 248.26
- Storage condition of test material: not indicated in the study report
- Batch no.: 294
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffs, UK
- Age at study initiation: 5 to 8 weeks
- Weight at study initiation: 347 - 423 g
- Housing: The animals were housed in groups of five is suspended metal cages with wire mesh floors.
- Diet: Free access to vitamin C enriched guinea-pig diet (Harlan Teklad 9600 FD2 SQC). Hay was given thrice weekly.
- Water: Free access to water.
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 30
- Humidity (%): 40 to 68
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Concentration of test material and vehicle used at induction: 7.5% for the intradermal induction and 50% for the epidermal induction (v/v in distilled water)
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Concentration of test material and vehicle used at challenge: 10 and 5% v/v in distilled water
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Details on study design:
- RANGE FINDING TESTS (6 animals)
The animals for the topical irritancy investigations were pre-treated with an intradermal injection of Freund's complete adjuvant, 50:50 with water for irrigation, approximately one week prior to the start of the preliminary investigations.
Based on the results of the preliminary investigations, the following concentrations were selected:
Induction intradermal injection: 7.5%, this was the highest concentration that caused irritation but did not adversely affect the animals.
Induction topical application: 50%, this was the highest concentration that produced some irritation but did not adversely affect the animals.
Topical challenge: 10 and 5%, from preliminary investigations 10% was the highest concentration not giving rise to irritating effects.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
1) Intradermal injections on day 1:
- Concentration: 7.5%
- Site: dorsal skin on the scapular region.
Three pairs of intradermal injections:
1) 0.1 mL: FCA (50% in water for irrigation)
2) 0.1 mL: test substance at a 7.5% concentration (control animals: 0.1 mL corn oil)
3) 0.1 mL: test substance at a 7.5% concentration in a 50:50 mixture of FCA and water for irrigation.
2)Topical application on day 8:
- Concentration: 50% in distiiled water
- Amount: 0.4 mL (control animals: 0.4 mL of distilled water)
- Area: approximately 8 cm^2
- Exposure period: 48 hours (occlusive)
- Readings: scores were rated directly after patch removal
B. CHALLENGE EXPOSURE (all animals, with the 10 and 5% test substance in distilled water)
- Day of challenge: day 22
- Exposure period: 24 hours (occlusive)
- Site: left flank
- Amount: 0.2 mL
- Readings: scores were rated 24 and 48 hours after patch removal - Challenge controls:
- Not applicable.
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole (June/July 1998)
Results and discussion
- Positive control results:
- The latest reliability check (performed less than 6 months ago) produced evidence of skin sensitisation in all of the animals.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No signs of ill health or toxicity were recorded.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No signs of ill health or toxicity were recorded.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No signs of ill health or toxicity were recorded.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No signs of ill health or toxicity were recorded.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity were recorded.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity were recorded.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity were recorded.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity were recorded.
- Reading:
- other: Not specified
- Group:
- positive control
- Dose level:
- 40d and 83.3%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- The latest reliability check (performed less than 6 months ago) produced evidence of skin sensitisation in all of the animals.
Any other information on results incl. tables
No signs of ill health or toxicity were recorded. Bodyweight increases were recorded for all animals over the period of the study.
Induction:
Intradermal injections: Necrosis was recorded at sites receiving FCA in test and control animals. Slight irritation was seen in test animals at sites receiving the 7.5% test substance and no irritation was observed in most animal receiving water.
Topical application: No erythema was observed in most test animals following topical application. No erythema was seen in the control animals.
Challenge:
There were no dermal reactions seen in any of the test or control animals that were considered to be related to treatment, therefore all twenty test animals gave negative responses. Slight localised erythema was noted for one control and one test animal and was considered to represent background irritation.
In the reliability test (performed in June/July 1998), evidence of skin sensitisation was shown in all of the ten animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this adjuvant type guinea pig test method for skin sensitisation according to OECD 406 guideline and GLP principles, Aero® 6697 Promoter did not produce evidence of skin sensitization in any of the twenty test animals.
- Executive summary:
Assessment of the skin sensitization potential of Aero® 6697 Promoter, a 50% solution in water, using the guinea-pig, according to OECD 406 guideline and GLP principles. No signs of ill health or toxicity were recorded. Bodyweight increases were recorded for all animals over the period of the study.
Induction:
Intradermal injections: Necrosis was recorded at sites receiving FCA in test and control animals. Slight irritation was seen in test animals at sites receiving the 7.5% test substance and no irritation was observed in most animal receiving water.
Topical application: No erythema was observed in most test animals following topical application. No erythema was seen in the control animals.
Challenge:
There were no dermal reactions seen in any of the test or control animals that were considered to be related to treatment, therefore all twenty test animals gave negative responses. Slight localised erythema was noted for one control and one test animal and was considered to represent background irritation.
Based on the results, Aero® 6697 Promoter, a 50% solution in water, did not produce evidence of skin sensitization in any of the twenty test animals.
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