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EC number: 444-960-2 | CAS number: 39148-16-8
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 May - 21 Jun 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (adopted in July 1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- (adopted in July 1996)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- (adopted in August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Republique Francaise, Premier Ministre, Groupe Interministeriel Des Produits Chimiques, Paris Cedex, France
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was initiated prior to the implementation of the LLNA method.
Test material
- Reference substance name:
- -
- EC Number:
- 444-960-2
- EC Name:
- -
- Cas Number:
- 39148-16-8
- Molecular formula:
- C2H6O3P.Na
- IUPAC Name:
- sodium ethyl phosphonate
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hartley Crl: (HA) BR
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, L'Arbresle, France
- Age at study initiation: 1 - 2 months
- Weight at study initiation: 352 ± 27 g (males), 354 ± 20 g (females)
- Housing: individually in polycarbonate cages with stainless steel lid and autoclaved sawdust
- Diet: 106 pelleted diet (UAR, Villemoisson, Epinay-sur-Orge, France), ad libitum
- Water: filtered water (FG Millipore membrane (0.22 micron) , ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30 - 70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 17 May To: 21 June 2002
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 1%
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 40%
- Day(s)/duration:
- 48 h
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 25%
- Day(s)/duration:
- On day 22 for 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- preliminary test: 2 (per sex, test group)
main study: 10 (per sex, test group), 5 (per sex, control) - Details on study design:
- RANGE FINDING TESTS:
Intradermal:
24 hours before treatment, the dorsal region of the animals was clipped. Injections were performed in the interscapular region.
Test concentrations: 0.1, 1, 5, 10 and 25% (w/w)
Evaluation of cutaneous reactions: 24 and 48 h, 6 days after the injections
Epicutaneous:
24 hours before treatment, both flank regions of the animals were clipped and shaved. The filter paper of a chamber (Finn Chamber®) was fully-loaded with a dosage form preparation. The chamber was then applied to the clipped area of the skin (one concentration per flank). The chamber was held in place by means of an occlusive dressing for 24 hours.
Test concentrations: 25 and 40% (w/w, 40% (maximal practicable concentration))
Evaluation of cutaneous reactions: 24 and 48 h after treatment or removal of the dressings
Criteria for the selection of concentrations suitable for the main test
- the concentrations should be well-tolerated (systemically and locally)
- intradermal injections should cause moderate irritant effects (no necrosis or ulceration of the skin)
- cutaneous application for the induction should cause a weak to moderate skin reaction or be the maximal practicable concentration
- cutaneous application for the challenge phase should be the highest concentration which does not cause irritant effects.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/physiological saline
Injection 2: test substance in physiological saline (1%, w/w)
Injection 3: test substance (1%, w/w) in a 1:1 mixture (v/v) FCA/physiological saline
Epicutaneous: 40% (w/w)
- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/physiological saline
Injection 2: physiological saline
Injection 3: physiological saline (50%, w/v) in a 1:1 mixture FCA/physiological saline
Epicutaneous: physiological saline
- Site: interscapular region (clipped on Day -1 and 7; clipped and shaved on Day 21 (flanks))
- Frequency of applications: every 7 days
- Duration: Days 1 - 10 (including maintainance of the occlusive dressing for 48 h)
- Concentration: 1% (intradermal), 40% (epicutaneous)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 h
- Test groups: test substance (right flank) and vehicle only (left flank)
- Control group: test substance (right flank) and vehicle only (left flank)
- Site: posterior right flank
- Concentrations: 25% (w/w)
- Evaluation (hr after challenge): 48 h and 72 h
Additional information on cutaneous exposure
The animals were teated with 0.5 mL sodium lauryl sulfonate (10%, in vaseline) one day prior to epicutaneous induction, in order to induce local skin irritation as the test substance failed to induce skin irritation after cutaneous application in the range finding test. - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- mercaptobenzothiazole (June 2002; control: 5 animals, test group: 10 animals; induction: intradermal: 1% (w/w), epicutaneous: 20% (w/w); challenge: 20% (w/w)
Results and discussion
- Positive control results:
- Challenge with 20% mercaptobenzothiazole resulted in skin sensitisation in 10/10 test animals scored with grade 1-3 detected at the 24 and 48 h reading time point. In the control group, no cutaneous reactions were observed.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction intradermal: 1%, challenge: 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: 0%, challenge: 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction intradermal: 1%, challenge: 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- induction intradermal: 1%, challenge: 20%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- weak, mild or moderate sensitisation in 1/10, 4/10 or 5/10 animals, respectively; oedema in 4/10 test animals and crusts in 2/10 animals; dryness of the skin in 5/10 animals
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- induction intradermal: 1%, challenge: 20%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- mild and moderate sensitisation in 4/10 or 6/10 animals, respectively; oedema in 8/10 animals, crusts in 1/10 animals; dryness of the skin in all animals
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Results of the range finding test
Intradermal injection of 0.1 - 25% (w/w) test substance induced cutaneous irritation 24 and 48 h after treatment in all animals. Injection of 25% test item solution resulted in necrosis in 1/2 animals detected 48 h after treatment. 6 days after treatment, necrosis was observed in both animals after injection of 5, 10 and 25% test item solution. 6 days after substance injection, crusts were observed in 2/2 animals after injection of 0.1 or 1% test item solution mixed with FCA. Challenge with 40% (w/w) test substance solution induced cutaneous reactions in 1/2 animals (grade 1) 24 h after treatment whereas challenge with 25% test substance solution failed to induce reactions on the skin. In accordance to the criteria for the selection of the concentrations suitable for the main study (please see above under "Details on study design"), concentrations of 1 and 40% (w/w) were chosen for intradermal and epicutaneous induction, respectively, and for challenge 25%.
Results of the main study
Mortality
No mortality or signs of clinical symptoms were recorded until the end of the observation period.
Body weight
Body weight gain was comparable between the test and control group.
Skin reactions
Important local reactions were recorded between Day 6 and Day 16 at the intradermal injection sites of 2 animals of the treated group. After challenge, no cutaneous reactions were observed in control animals. In test animals, a discrete erythema scored with grade 1 was observed on both flanks in 1/20 animals at the 24 hours reading time point. A similar cutaneous reaction was observed in one further animal at the 48 h reading time point on the left flank (vehicle-treated flank). As the cutaneous reactions were determined either on the control and test item treated flank or on the control flank only, the observations were not interpreted as sign of sensitisation. 3/20 test animals revealed dryness of the skin 48 h after patch removal. No other cutaneous reactions were recorded in the test group.
Positive control
Challenge with the positive control substance revealed positive sensitisation reactions in 10/10 test animals at both time points. 48 h after patch removal, weak, mild or moderate reactions were observed on the right flank treated with the positive control substance during induction and challenge in 1/10, 4/10 or 5/10 animals, respectively. In addition, weak or mild sensitisation was observed on the left flank treated with the vehicle during the induction phase in 1/10 and 2/10 animals, respectively. Moreover, oedema and crusts were observed on the right flank treated with the positive control substance during induction and challenge in 4/10 or 2/10 animals, respectively. Dryness of the skin was determined in 5/10 animals. At the later reading time point, mild and moderate skin sensitisation was observed in 4/10 or 6/10 animals, respectively. Weak or mild sensitisation was also observed on the left flank in 2/10 animals each. Moreover, the flank treated wih the positive control during induction and challenge revealed oedema and crusts in 8/10 or 1/10 animals, respectively. Dryness of the skin was observed in 9/10 animals at the second reading time point.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions chosen, the test substance was not a skin sensitizer in guinea pigs.
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