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EC number: 204-707-7 | CAS number: 124-64-1
- 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
- By analogy, the test substance is considered as a skin sensitizer (OECD 406, Kr.2, GLP).
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
- Justification for type of information:
- No data on skin sensitisation are available for THPC. However, a similar substance (THPS) was demonstrated to be skin sensitiser (Guess, 1994). Information from THPS is judged relevant because as an ionic salt, THPC is completely dissociated into THP+ and Cl- in aqueous solutions and the equivalent is true for most of the THP+ salts, including sulphate salt. As a consequence hazard properties evaluated in aqueous solution could reasonably be predicted using data from the equivalent sulphate salt. Therefore a read-across approach could be done for certain hazard properties between THPC (chloride salt) and THPS (sulphate salt).
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75% (v/v)
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Clinical observations:
- oedema, erythema, grey/green coloured dermal necrosis beyond the challenge site and a dark brown- coloured scab adjacent to to the challenge site.
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- 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:
- 48
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- November- december 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study, performed according to standard method, read-across with THPC.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- see below
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- see below
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- see below
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- see below
- Principles of method if other than guideline:
- Deviations from the current OECD 406 (17/07/1992) test guideline:
The grading scale was from 0 to 4 both for erythema and oedema formation, according to Draize (1959), instead of 0 to 3 for erythema
formation as described in the OECD guideline 406. - GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study performed before the adoption of the OECD 429 guideline.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Ltd., UK
- Age at study initiation: 8-12 weeks old
- Weight at study initiation: 333-410 g
- Housing: in groups of up to three in solid-floor polypropylene cages furnished with woodflakes
- Diet/ water : Free access to mains tap water and food
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-22°C
- Humidity: 50-66%
- Air changes (per hr): 15
- Photoperiod: 12 hr dark / 12 hr light
IN-LIFE DATES: From 16 November 1993 to 24 December 1993 - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- see below, details on study design
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- see below, details on study design
- No. of animals per dose:
- 30 (20 in the test group; 10 in the control group)
- Details on study design:
- RANGE FINDING TESTS:
The selection of the concentrations used for the induction and challenge phases (see above) in the main study was based on the results of the pilot studies.
For the selection of concentration for topical challenge, the tested concentration range, 4 concentrations from 5 to 50 % v/v (as active substance; THPS 75%) for 24 hours, none of the two tested guinea pigs showed any skin reaction. According to this result, it was decided to use the highest tested concentration inducing no irritation effect (50 % v/v active substance) on one flank region and a higher concentration ensuring a positive skin reaction (75 % v/v) on the other flank side.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
1st application: Induction 0.1 % intracutaneous (day 0)
2nd application: Induction 25 % occlusive epicutaneous (day 7)
- Site: the shoulder region of each animal
- Duration: 48h
Concentrations for induction: (day 0 and 7)
Intradermal induction: 0.1% w/v in distilled water, that is 0.75 µg main ingredient/mL,
Topical induction: 25% v/v in distilled water, that is 34.8 µg active substance/mL or 26.1 µg main ingredient/mL.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
3rd application: Challenge 75 % occlusive epicutaneous
- Day(s) of challenge: 21
- Exposure period: test substance was removed using water 24 hours following application
- Site: the shorn right flank of each animal
Two concentrations were used for challenge: (day 21)
- 50% v/v in distilled water (69.6 µg active substance/mL or 52.2 µg main ingredient/mL) applied on the left flank, which is the highest concentration producing no evidence of skin irritation 24 and 48 hours after dressing removal,
- and 75% v/v in distilled water (104.4 µg active substance/mL or 78.3 µg main ingredient/mL) applied on the right flank, to ensure that the maximum non-irritant concentration (50 % v/v) was really used at challenge.
- examination: skin response, bodyweight
- Evaluation: 24 and 48 h after challenge - Challenge controls:
- 10 animals
- Positive control substance(s):
- no
- Positive control results:
- not applicable
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75% (v/v)
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Clinical observations:
- oedema, erythema, grey/green coloured dermal necrosis beyond the challenge site and a dark brown- coloured scab adjacent to to the challenge site.
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- 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:
- 48
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- By analogy, the test substance is classified as a skin sensitizer according to EU criteria.
- Executive summary:
This skin sensitisation test was performed with THPS 75% in water with male albino guinea pigs, according to the OECD Guideline 406. Twenty test and ten control animals were used for the main study. Based on the results of the pilot tests, the concentrations of test material were 0.1 % (w/v) and 25 % (v/v) for the intradermal and topical applications of the induction phase, respectively, and 50 % or 75 % (v/v) in the challenge phase.
Expressed as main ingredient, the used concentrations were as follows, considering a THPS concentration of 75 %:
- Intradermal induction: 0.1 %w/v of THPS 75 % = 0.75 µg/mL,
- Topical induction: 25 % v/v of THPS 75 % = 26.1 µg/mL,
- Topical challenge: 50 % v/v of THPS 75 % = 52.2 µg/mL
75 % v/v of THPS 75 % = 78.3 µg/mL
Main skin reactions for each step were:
(1) Intradermal induction:
Very slight to well defined erythema for all test group animals at hour 24 post-injection and in eighteen test group animals at the 48-hour observation. Very slight erythema was noted at the vehicle intradermal injection sites of five control group animals at the 24-hour observation; all control animals recovered at hour 48 post-injection.
(2) Topical induction:
Very slight to well-defined erythema with or without very slight oedema was noted at the induction sites of eleven test group animals one hour after dressing removal. Only erythema was noted for 4 animals at the 24-hour observation. No skin reactions were noted at the treatment sites of control group animals at the one and 24-hour observations.
(3) Topical challenge:
Positive sensitisation responses, identified as very slight to well-defined erythema with or without very slight to slight oedema, were noted at the challenge sites of fourteen test animals at the 24 and 48-hour observations. The skin reactions extended beyond challenge sites of five test animals on hour 24 post-application and four test animals on hour 48. Skin exposure to a test material concentration of 75 % showed skin reactions from very slight to moderate erythema and oedema for all test animals.
No skin reaction was observed at the challenge sites of control group animals at the 24 and 48-hour observations.
In conclusion, THPS appears to be a strong sensitizer as it produced a 70% (14/20) sensitisation rate on guinea pig skin.
Referenceopen allclose all
After an injection of 0.1 % w/v of the test material, a topical induction at 25 % seven days after the injection, and a topical challenge at 50 % on day
21 post-injection, fourteen guinea pigs on the twenty treated animals showed irritation signs, against non from the control group. The test material
produced a 70% sensitization rate and was classified as a strong sensitiser to guinea pig skin.
Considering a relative density of 1.392 and a THPS concentration of 75 %, exposure concentrations expressed as main ingredient are
as follow:
(1) intradermal induction: 0.075 % w/v = 0.75 g/L
(2) topical induction: 26.1 g/L
(3) topical challenge: 52.2 g/L
Main skin reactions for each step were:
(1) Intradermal induction:
Very slight to well defined erythemafor all test group animals at hour 24 post-injection and in eighteen test group animals ot the 48-hour observation.
Very slight erythema was noted at the vehicle intradermal injection sites of five control group animals at the 24-hour observation; all control animals
recovered at hour 48 post-injection.
(2) Topical induction:
Very slight to well-defined erythema with or without very slight oedema was noted at the induction sites of eleven test group animals one hour after
dressing removal. Only erythema was noted for 4 animals at the 24-hour observation. No skin reactions were noted at the treatment sites of control
group animals at the one and 24-hour observations.
(3) Topical challenge:
Positive sensitisation responses, identified as very slight to well-defined erythema with or without very slight to slight oedema, were noted at the
challenge sites of fourteen test four animals at the 24 and 48-hour observations. The skin reactions extended beyond challenge sites of five test
animals on hour 24 post-application and four test animals on hour 48. Skin exposure to a test material concentration of 75 % showed skin reactions
from very slight to moderate erythema and oedema for all test animals.
No skin reaction was observed at the challenge sites of control group animals at the 24 and 48-hour observations. Only a focal necrosis was
noted for one control animal on hours 24 and 48 post-application.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
No data on skin sensitisation are available for THPC. However, a similar substance (THPS) was demonstrated to be skin sensitiser (Guess, 1994). Information from THPS is judged relevant because as an ionic salt, THPC is completely dissociated into THP+ and Cl- in aqueous solutions and the equivalent is true for most of the THP+ salts, including sulphate salt. As a consequence hazard properties evaluated in aqueous solution could reasonably be predicted using data from the equivalent sulphate salt. Therefore a read-across approach could be done for certain hazard properties between THPC (chloride salt) and THPS (sulphate salt).
THPC is characterised by corrosive properties; then according to Column 2 of the REACH regulation (1907/2006) studies on skin sensitisation should not be conducted. However, based on available data for a similar substance (THPS) it is expected that THPC may have sensitising properties to skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Even if no data are available on THPC for skin sensitisation, a read-across approach done with a similar substance (THPS) is judged relevant for considering the substance of interest as Skin sensitising Category 1 according to CLP regulation (EC) n°1272/2008.
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