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EC number: 250-528-2 | CAS number: 31242-17-8
- 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
The allergic contact sensitization potential of test item was evaluated in15 female Hartley Albino guinea pigs following intradermal injection and 2 topical occlusive exposures.
Animals of the treated group received 5.0% and 100% test item during the intradermal and topical induction phases, respectively. Following topical challenge with 5.0% test item, animals of the treated group exhibited a lower incidence of dermal irritation than the control group animals. In the opinion of the Study Director, the test item should not be classified as askin sensitizer.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
- 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: Read-across
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- THE GUINEA-PIG MAXIMISATION TEST METHOD
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study pre-dates the devleoment of the LLNA method.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Dutchiand, Inc., Denver, PA
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 5 to 6 weeks
- Weight at study initiation: 295 to 369 grams
- Housing: Individual - suspended stainless steel cages
- Diet: ad libitum - Purina Guinea Pig Chow (pellets)
- Water: Automatic watering system (ad libitum)
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 65 to 71 F
- Humidity (%): 40 to 70%
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark by automatic timer
- IN-LIFE DATES: From: To: 5th July 1983 to 17th August 1983 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: Primol 185 (white oil)
- Concentration / amount:
- Intradermal Injection - 5% test item in vehicle/FCA
Epicutaneous - 100% Test item - Day(s)/duration:
- Intradermal Injection - Day 0. Epicutaneous - Day 7 (48 hour exposure)
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: Primol 185 (White oil)
- Concentration / amount:
- 0.5 mL of 5% test item in vehicle
- Day(s)/duration:
- Day 21 - 24 hours exposure
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Treatment Group - 15 animals
Control Group - 15 animals - Details on study design:
- A preliminary range finding screen was conducted from June 20, 1983 to July 13, 1983 to determine the appropriate concentrations of test item to be used in the 3 phases of dosing: intradermal induction, topical induction, and topical challenge.
For the first phase of dosing, the attempted induction of sensitization by intradermal injection, solutions of 5.0% (w/v) test item in vehicle and 5.0% (w/v) test tiem in diluted FCA were prepared. The preliminary screen indicated that this was the highest concentration of test material that could be initradermally injected without producinq local necrosis or ulceration of the injection site and was sufficiently free of systemic toxicity, so as not to impair the health of the animal.
Neat (100%) test tetm was prepared for the second phase of dosing, attempted induction by occlusive topical application. The preliminary screen indicated that this was the highest concentration of test material which would produce no more than mild to moderate irritation (erythema score less than or equal to 2) when applied topically.
A solution of 5.0% (w/v) test item in vehicle was prepared for the third phase of dosing, challenge by occlusive topical .app1ication The preliminary screen indicated that this was the highest concentration of test material that could be topically applied without producing any macroscopic signs of irritation.
Administration of test material
The sensitization assay was conducted in 3 phases:
1) Day 0 — induction of sensitization by intraderm.al injection of a maximally tolerated dose of test material, alone and in combination with adjuvant;
2) Day 7 — subsequent induction by occlusive epidermal application of a mild to moderately irritating dose; and
3) Day 21 — challenge for sensitization by occlusive epidermal application of a non—irritating dose of the test material.
Administration of induction injections - Day 0:
A pair of 0.1 ml injections of the following solutions was intradermally administered to each of 3 sites in the clipped mid-dorsal reqion of all animals, near the
scapula:
Site 1 — diluted ECA to both treated and control groups
Site 2 — 5.0% test item in vehicle to the treated group and undiluted vehicle to the control group
Site 3 — 5.0% test item in diluted FCA to the treated group and diluted ECA to the control group
The solutions were intradermally injected via a 1.0 cc syringe and 25 gauge needle. A row of 3 injections, 0.1 ml of each solution, were given along both sides of the spinal cord for a total of 6 injections. Solutions for Site 1 and Site 2 were injected close toqether and near the first thoracic vertebra; the solution for Site 3 was injected more caudally. All injections were made 1 to 2 cm from the midline, within a 3 x 4 cm area, and within, the boundaries of the clipped region.
Induction by occlusive topical application — Day 7:
Seven days after intradermal induction, 0.5 ml of 100% test item was topically applied over the injection sites on the shoulder reqion of the treated group animals. The test material was applied beneath a Webril cotton pad, covered by overlapping Derrnicel plastic tape and firmly secured to the torso of the animals with elastic adhesive bardaging. Control group animals received 0.5 ml of vehicle alone, applied identically. The oil based solution was applied directly to the skin. The pads and sleeving were removed from both the treated and control group animals after approximately 48 hours.
Challenge by occlusive topical application — Day 21:
Twenty-one days after intradermal induction 0.5 ml of 5.0% test item in vehicle was topically applied to the clipped area on the right flank of both treated and control group animals. The test material was applied beneath a Webril cotton pad, covered by overlapping Blenderm plastic tape, arid firmly secured to the torso of the animals with elastic adhesive bandaging in a manner such that no adhesive came in contact with the skin at the challenge site. The oil based solution was applied directly to the skin. The pads and sleeving were removed from both treated and control animals after approximately 24 hours.
Experimental evaluation
The animals were checked for viability once in the morning (before approximately 10:30 AM) and once in the afternoon (after approximately 3:00 PM).
In-life observations were made as to the nature, onset and severity and duration of toxicological signs immediately after dosing on Day 0 and on Days 7, 10, 14, 21 and each time dermal observations were made.
Body weights were recorded on Days 0, 7, 14, 21 and at sacrifice.
On Day 10, approximately 24 hours after removal of the induction patch, dermal responses were evaluated. On Day 23, approximately 21 hours after removal of the challenge patch, the challenqe area was genitly cleaned with physiological saline and clipped. Dermal responses were evaluated at approximately 24 and 48 hours after removal of the challenqe patch according to the Draize Method of Scoring. Sensitization was evaluated by comparing the reactions of treated animals with the reactions of control animals that had received a single epidermal exposure to the test material. Control responses were used to distinguish true sensitization from local irritation produced by the same concentration of test material.
After the final dermal observations, all animals were weighed, sacrificed by carbon dioxide asphyxiation, and discarded without fither examination. - Challenge controls:
- Treated and control group animals were handled identically in all 3 phases of dosing with the only exception being that control group animals received vehicle in place of test material during the intradermal and topical induction phases.
- Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the opinion of the Study Director, the test item should notbeclassified as a skin sensitizer.
- Executive summary:
The allergic contact sensitization potential of test itemwasevaluated in15 female Hartley Albino guinea pigs following intradermal injection and 2 topical occlusive exposures. A control group of 15 female guinea pigs received only a single topical exposure to the test material The technique employed was similar to that described by B. Magnusson arid A. Kligman in: ‘The identification of contact allergens by animal assay. Theguineapig maximization test’, Journal of Investigative Dermatology, Vol. 52: 268-276, 1969. Evaluation of sensitization potential was based on a comparison of treated and control group dermal scores.
Dermal responses were evaluated approximately 24 hours after removal of the induction patch, and 24and 48hours after removal of the challenge patch, according to the Draize Method of scoring. Observations were made as to the nature, onset, severity and duration of toxicological signs immediately after dosing on Day 0 and on Days 7, 10, 14, 21, 23 and 24. body weights were recorded at initiation of dosing and on Days 7, 14, 21 and at sacrifice. After the final dermal observations and weighing, all animals were sacrificed by carbon dioxide asphyxiation and discarded without further examination.
All animals survived to study termination displaying normal weight gain patterns.
Animals of the treated group received 5.0% and 100% test item during the intradermal and topical induction phases, respectively. Following topical challenge with 5.0% test item, animals of the treated group exhibited a lower incidence of dermal irritation than the control group animals. In the opinion of the Study Director, the test item should notbeclassified as a skinsensitizer.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- See section 13 for read-across justification
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- THE GUINEA-PIG MAXIMISATION TEST METHOD
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study pre-dates the devleoment of the LLNA method.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Dutchiand, Inc., Denver, PA
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 5 to 6 weeks
- Weight at study initiation: 295 to 369 grams
- Housing: Individual - suspended stainless steel cages
- Diet: ad libitum - Purina Guinea Pig Chow (pellets)
- Water: Automatic watering system (ad libitum)
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 65 to 71 F
- Humidity (%): 40 to 70%
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark by automatic timer
- IN-LIFE DATES: From: To: 5th July 1983 to 17th August 1983 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: Primol 185 (white oil)
- Concentration / amount:
- Intradermal Injection - 5% test item in vehicle/FCA
Epicutaneous - 100% Test item - Day(s)/duration:
- Intradermal Injection - Day 0. Epicutaneous - Day 7 (48 hour exposure)
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: Primol 185 (White oil)
- Concentration / amount:
- 0.5 mL of 5% test item in vehicle
- Day(s)/duration:
- Day 21 - 24 hours exposure
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Treatment Group - 15 animals
Control Group - 15 animals - Details on study design:
- A preliminary range finding screen was conducted from June 20, 1983 to July 13, 1983 to determine the appropriate concentrations of test item to be used in the 3 phases of dosing: intradermal induction, topical induction, and topical challenge.
For the first phase of dosing, the attempted induction of sensitization by intradermal injection, solutions of 5.0% (w/v) test item in vehicle and 5.0% (w/v) test tiem in diluted FCA were prepared. The preliminary screen indicated that this was the highest concentration of test material that could be initradermally injected without producinq local necrosis or ulceration of the injection site and was sufficiently free of systemic toxicity, so as not to impair the health of the animal.
Neat (100%) test tetm was prepared for the second phase of dosing, attempted induction by occlusive topical application. The preliminary screen indicated that this was the highest concentration of test material which would produce no more than mild to moderate irritation (erythema score less than or equal to 2) when applied topically.
A solution of 5.0% (w/v) test item in vehicle was prepared for the third phase of dosing, challenge by occlusive topical .app1ication The preliminary screen indicated that this was the highest concentration of test material that could be topically applied without producing any macroscopic signs of irritation.
Administration of test material
The sensitization assay was conducted in 3 phases:
1) Day 0 — induction of sensitization by intraderm.al injection of a maximally tolerated dose of test material, alone and in combination with adjuvant;
2) Day 7 — subsequent induction by occlusive epidermal application of a mild to moderately irritating dose; and
3) Day 21 — challenge for sensitization by occlusive epidermal application of a non—irritating dose of the test material.
Administration of induction injections - Day 0:
A pair of 0.1 ml injections of the following solutions was intradermally administered to each of 3 sites in the clipped mid-dorsal reqion of all animals, near the
scapula:
Site 1 — diluted ECA to both treated and control groups
Site 2 — 5.0% test item in vehicle to the treated group and undiluted vehicle to the control group
Site 3 — 5.0% test item in diluted FCA to the treated group and diluted ECA to the control group
The solutions were intradermally injected via a 1.0 cc syringe and 25 gauge needle. A row of 3 injections, 0.1 ml of each solution, were given along both sides of the spinal cord for a total of 6 injections. Solutions for Site 1 and Site 2 were injected close toqether and near the first thoracic vertebra; the solution for Site 3 was injected more caudally. All injections were made 1 to 2 cm from the midline, within a 3 x 4 cm area, and within, the boundaries of the clipped region.
Induction by occlusive topical application — Day 7:
Seven days after intradermal induction, 0.5 ml of 100% test item was topically applied over the injection sites on the shoulder reqion of the treated group animals. The test material was applied beneath a Webril cotton pad, covered by overlapping Derrnicel plastic tape and firmly secured to the torso of the animals with elastic adhesive bardaging. Control group animals received 0.5 ml of vehicle alone, applied identically. The oil based solution was applied directly to the skin. The pads and sleeving were removed from both the treated and control group animals after approximately 48 hours.
Challenge by occlusive topical application — Day 21:
Twenty-one days after intradermal induction 0.5 ml of 5.0% test item in vehicle was topically applied to the clipped area on the right flank of both treated and control group animals. The test material was applied beneath a Webril cotton pad, covered by overlapping Blenderm plastic tape, arid firmly secured to the torso of the animals with elastic adhesive bandaging in a manner such that no adhesive came in contact with the skin at the challenge site. The oil based solution was applied directly to the skin. The pads and sleeving were removed from both treated and control animals after approximately 24 hours.
Experimental evaluation
The animals were checked for viability once in the morning (before approximately 10:30 AM) and once in the afternoon (after approximately 3:00 PM).
In-life observations were made as to the nature, onset and severity and duration of toxicological signs immediately after dosing on Day 0 and on Days 7, 10, 14, 21 and each time dermal observations were made.
Body weights were recorded on Days 0, 7, 14, 21 and at sacrifice.
On Day 10, approximately 24 hours after removal of the induction patch, dermal responses were evaluated. On Day 23, approximately 21 hours after removal of the challenge patch, the challenqe area was genitly cleaned with physiological saline and clipped. Dermal responses were evaluated at approximately 24 and 48 hours after removal of the challenqe patch according to the Draize Method of Scoring. Sensitization was evaluated by comparing the reactions of treated animals with the reactions of control animals that had received a single epidermal exposure to the test material. Control responses were used to distinguish true sensitization from local irritation produced by the same concentration of test material.
After the final dermal observations, all animals were weighed, sacrificed by carbon dioxide asphyxiation, and discarded without fither examination. - Challenge controls:
- Treated and control group animals were handled identically in all 3 phases of dosing with the only exception being that control group animals received vehicle in place of test material during the intradermal and topical induction phases.
- Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the opinion of the Study Director, the test item should notbeclassified as a skin sensitizer.
- Executive summary:
The allergic contact sensitization potential of test itemwasevaluated in15 female Hartley Albino guinea pigs following intradermal injection and 2 topical occlusive exposures. A control group of 15 female guinea pigs received only a single topical exposure to the test material The technique employed was similar to that described by B. Magnusson arid A. Kligman in: ‘The identification of contact allergens by animal assay. Theguineapig maximization test’, Journal of Investigative Dermatology, Vol. 52: 268-276, 1969. Evaluation of sensitization potential was based on a comparison of treated and control group dermal scores.
Dermal responses were evaluated approximately 24 hours after removal of the induction patch, and 24and 48hours after removal of the challenge patch, according to the Draize Method of scoring. Observations were made as to the nature, onset, severity and duration of toxicological signs immediately after dosing on Day 0 and on Days 7, 10, 14, 21, 23 and 24. body weights were recorded at initiation of dosing and on Days 7, 14, 21 and at sacrifice. After the final dermal observations and weighing, all animals were sacrificed by carbon dioxide asphyxiation and discarded without further examination.
All animals survived to study termination displaying normal weight gain patterns.
Animals of the treated group received 5.0% and 100% test item during the intradermal and topical induction phases, respectively. Following topical challenge with 5.0% test item, animals of the treated group exhibited a lower incidence of dermal irritation than the control group animals. In the opinion of the Study Director, the test item should notbeclassified as a skinsensitizer.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the data on the source substance, which showed no signs of skin sensitization in an OECD 406 Buehler Study, it is concluded that no classification is required in accoedance to Regulation (EC) No. 1272/2008.
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