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EC number: 236-152-1 | CAS number: 13194-48-4
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March - April 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EPA Pesticide Assessment Guidelines
- Deviations:
- yes
- Remarks:
- no weighing at termination (purpose or integrity of the study not affected)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted in 1984 when the LLNA was not yet an established method with regulatory acceptance.
Test material
- Reference substance name:
- Ethoprophos
- EC Number:
- 236-152-1
- EC Name:
- Ethoprophos
- Cas Number:
- 13194-48-4
- Molecular formula:
- C8H19O2PS2
- IUPAC Name:
- ethyl bis(propylsulfanyl)phosphinate
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Redfern Animal Breeders, Ely Grange, Frant, Tunbridge-Wells,TN3 9DZ.
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: young, no further specification
- Weight at study initiation: 484 to 531 g
- Housing: caged in groups of 2 by dose group in grid floor polypropylene cages
- Diet (ad libitum): (Guinea Pig diet, Standard with Vitamin C, Special Diets Services Ltd., Stepfield, Witham, Essex
- Water (ad libitum): yes, quality was issued by the Yorkshire Water Authority
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 40 - 69
- Air changes (per hr):- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- polyethylene glycol
- Remarks:
- 200
- Concentration / amount:
- 1 mL; 1% v/v
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- other: well tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- 200
- Concentration / amount:
- 0.5 mL; 10% v/v
- Day(s)/duration:
- Day 7; 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- 200
- Concentration / amount:
- 0.5 mL; 10% v/v
- Day(s)/duration:
- Day 21; 24 h
- Adequacy of challenge:
- other: highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No. of animals per dose:
- 20 animals
- Details on study design:
- RANGE FINDING TESTS:
Toxicity data indicated the test article was toxic by dermal application. To confirm this toxicity and to establish the threshold irritant concentrations a screening study was performed. The test article in corn oil was applied at doses of 10, 50 and 100 mg/kg bw to the shaved back of each animal once only under occlusive patches for a period of 6 hours. The animals were observed for mortality during the day of dosing and subsequently once daily for 7 days. In addition the treatment sites were assessed for irritation the day following treatment.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: intradermal: 3; topical: 1
- Exposure period: intradermal: not applicable; topical: 48 h
- Test groups: 1
intradermal induction:
1. 0.1 ml 1.0% v/v Ethoprop in polyethylene glycol 200
2. 0.1 ml Complete Adjuvant (50% v/v in water)
3. 0.1 ml 1.0% v/v Ethoprop emulsified in 50% v/v
- Control group: 1
intradermal induction:
1. 0.1 ml Polyethylene glycol
2. 0.1 ml Complete Adjuvant (50% v/v in water)
3. 0.1 ml Complete Adjuvant (50% v/v in water)
- Site: shoulder region
- Concentrations: intradermal: 1%; topical: 10%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: Day 21
- Exposure period: 24 h
- Test groups: 1
- Control group: 1
- Site: flank
- Concentrations: 10%
- Evaluation (hr after challenge): 24 and 48 - Challenge controls:
- Polyethylene glycol 200 (PEG 200)
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: negative challenge control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: negative challenge control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 9
- Total no. in group:
- 19
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 11
- Total no. in group:
- 19
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
RANGE FINDING TESTS:
No deaths were noted during the study period. Slight redness was noted on the treatment sites of both animals exposed to the test item at a concentration of 5.0% v/v. No irritation was noted on exposure to concentrations of 2.5% v/v or 0.5% v/v.
A concentration of 10% v/v test subtance was considered to be the maximum irritant concentration and was used for both topical induction and challenge.
MAIN STUDY
One test animal was found dead on day 9. Nine of the 19 surviving animals showed scattered mild redness at the 24 hour observation. These reactions were also seen in 11 of the 19 animals at the 48 hour observation. No adverse skin reactions were noted on the test animals using vehicle only. No adverse skin reactions were noted in control animals exposed to test and control articles at either the 24 or 48 hour observation.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The test item was shown to be a potential skin sensitiser under the conditions of this study.
- Executive summary:
Intradermal induction was performed on 20 test animals using 0.1 mL injections of the test item (1.0% v/v in PEG 200) and Freund’s Complete Adjuvant (50% v/v in water). Ten control animals were similarly treated, with vehicle replacing the test material. One week following intradermal induction, topical induction was performed on test animals using a 48 hour occlusive application of ethoprophos (10% v/v in PEG 200). Control animals were similarly treated with vehicle alone. Two weeks after topical induction, all animals were challenged using a 24 hour occlusive application of ethoprophos (10% v/v in PEG 200). Vehicle was applied to the opposite flank to serve as control. The test item caused scattered mild erythema in test animals at the ethoprophos-treated skin site as detailed below. Control animals and vehicle-treated flanks showed no skin reaction.
The test item was shown to be a potential skin sensitiser under the conditions of this study.
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