Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 222-048-3 | CAS number: 3327-22-8
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993-06-22 to 1993-07-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study from 1993 readily available
Test material
- Reference substance name:
- (3-chloro-2-hydroxypropyl)trimethylammonium chloride
- EC Number:
- 222-048-3
- EC Name:
- (3-chloro-2-hydroxypropyl)trimethylammonium chloride
- Cas Number:
- 3327-22-8
- Molecular formula:
- C6H15ClNO.Cl
- IUPAC Name:
- 3-chloro-2-hydroxy-N,N,N-trimethylpropan-1-aminium chloride
- Details on test material:
- 69.32 % solution of a 98.55 % pure solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White (Bor:DHPW)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH, Borchen, GERMANY
- Age at study initiation: 9 wk
- Weight at study initiation: 466-521 g (males); 382-471 g (females)
- Housing: 1/Macrolon cage type IV
- Diet: standared diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.0-20.5
- Humidity (%): 50-75%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: 1993-06-22 To: 1993-07-16
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 0.9% physiological saline
- Concentration / amount:
- Induction 0.5 % intracutaneous
Induction 100 % occlusive epicutaneous
Challenge 30 % occlusive epicutaneous
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 0.9% physiological saline
- Concentration / amount:
- Induction 0.5 % intracutaneous
Induction 100 % occlusive epicutaneous
Challenge 30 % occlusive epicutaneous
- No. of animals per dose:
- 10 treatment; 5 vehicle control
- Details on study design:
- (NB: TS is 69% aqueous solution)
RANGE FINDING TESTS: preliminary test conducted - no details given
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal-3 paired injections; topical)
- Exposure period: topical 48h
- Test group: 10
- Control group: +ve no details on group size; -ve (vehicle) 5
- Site: two rows of 3 sites, one row either side of dorsal mid-line
- Frequency of applications: intradermal treatment day 0; topical induction day 7
- Duration: induction period continues to day 21
- Concentrations:
intradermal: 1:1 FCA saline; 0.5% TS in saline; 0.5% TS 1:1 FCA
topical: 100% TS
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (at two sites: TS and vehicle)
- Day(s) of challenge: day 22
- Exposure period: 24 h
- Test group: 10
- Control group: +ve no details on group size; -ve (vehicle) 5
- Site: flank
- Concentrations: 30% TS in saline
- Evaluation (hr after challenge): 24 and 48 h following patch removal - Challenge controls:
- vehicle control
positive control - Positive control substance(s):
- yes
Results and discussion
- Positive control results:
- 1,4-phenylenediamine X2 HCl. Last examination April 1993. (No further details given)
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30% TS in saline (NB: TS is 69% in aqueous solution)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30% TS in saline (NB: TS is 69% in aqueous solution). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30% in saline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30% in saline. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- other: not specified
- Reading:
- 2nd reading
- Group:
- positive control
- Remarks on result:
- other: not specified
- Reading:
- 1st reading
- Group:
- negative control
- Remarks on result:
- other: not specified
- Reading:
- 2nd reading
- Group:
- negative control
- Remarks on result:
- other: not specified
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A well conducted, well reported guinea-pig skin sensitization test (Magnusson & Kligman method) found in the test substance (a 69% aqueous solution of CHPTAC) no evidence of sensitizing potential when challenged with a 30% solution of the TS in saline. Appropriate negative and positive controls were conducted.
- Executive summary:
In a dermal sensitization study (OECD 406) with CHPTAC (69% aqueous solution), young adult female guinea-pigs of the Dunkin-Hartley strain were tested using the method of Magnusson and Kligman. No dermal reactions were seen when challenging with a 30% solution of the test material in saline. In this study, CHPTAC (69%) is not a dermal sensitizer.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)