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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 260-599-1 | CAS number: 57158-29-9
- 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:
- 1986-01-03 to 1986-02-09
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Guideline conform study, conducted under GLP principles, with minor deficiencies when compared to contemporary standards: the purity and the stability of the test material were not stated in the study report. The guinea pig strain used in these laboratories is reported to have been shown to produce a satisfactoy sensitisation response using positive sensitisers. However, it was not stated in the study report which positive sensitisers were tested or when the last test was conducted. According to the guideline, the test have be conducted at least every six months.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981-05-12
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The conduct of this study was prior to the establishment of the LLNA method (OECD 429).
Test material
- Reference substance name:
- Rezal 36 GP powder
- IUPAC Name:
- Rezal 36 GP powder
- Details on test material:
- - Name of test material (as cited in study report): Rezal 36 GP powder
- Label: Ref.QC 1433/569 REZAL 36 GP Aluminium Zirconium Tetra Chlorhydrex Gly powder
- Physical state: white powder
- Storage condition of test material: room temperature
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
- Age at study initiation: approximately seven to eleven weeks old
- Weight at study initiation: 365 - 410 g
- Housing: the animals were housed in groups of up to four in solid floor polypropylene cages furnished with softwood shavings.
- Diet (ad libitum): Guinea Pig FD1 Diet, Special Diet Services Limited, Witham, Essex, U.K.
- Water (ad libitum): mains tap water
- Acclimation period: minimum of five days
ENVIRONMENTAL CONDITIONS
- Temperature: 17 - 23°C
- Relative humidity: 45 - 65%
- Air exchanges: approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: 0.5% (w/v) in distilled water
Topical induction: 50% (w/w) in distilled water
Topical challenge: 50% (w/w) in distilled water
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: 0.5% (w/v) in distilled water
Topical induction: 50% (w/w) in distilled water
Topical challenge: 50% (w/w) in distilled water
- No. of animals per dose:
- Sighting study: 8 animals (intradermal 4 animals; topical 4 animals)
Main study:
test group: 20 animals
vehicle control group: 10 animals - Details on study design:
- RANGE FINDING TESTS:
The dose levels for each of the three stages of the main study were determined by a 'sighting study' in which two groups of four guinea pigs were used. The procedure was as follows:
i) Intradermal injection (induction): dilutions of the test material in distilled water (0.5, 0.1, 1 and 5% concentrations) were tested to determine the highest level that could be well tolerated both locally and systemically.
ii) Topical application (induction): dilutions of the test material in distilled water (25% and 50% concentrations) were tested to determine the highest level which did not produce excessive inflammation in animals injected with Freund's Complete Adjuvant (Difco Laboratories, Michigan, U.S.A.) at least seven days previously.
iii) Topical application (challenge): dilutions of the test material in distilled water (25% and 50% concentrations) were tested to determine the highest level which did not produce inflammation or irritation in animals injected with Freund's Complete Adjuvant at least seven days previously.
Results:
- Intradermal sighting test: the concentration of the test material to be used for the intradermal induction stage of the main study was selected to be 0.5% (w/v) in distilled water.
- Topical sighting study: the concentration of the test material to be used for the main study was selected as follows:
topical induction = 50% (w/w) in distilled water
topical challenge = 50% (w/w) in distilled water
MAIN STUDY
A. INDUCTION EXPOSURE
1) Test animals:
The hair was removed from an area approximately 40 mm X 60 mm on the shoulder region of each animal with veterinary clippers and a row of three injections (0.1 mL each) was made on each side of the midline. The injections were:
i) Freund's Complete adjuvant plus distilled water in the ratio 1:1.
ii) a 0.5% (w/v) dilution of test material in distilled water.
iii) a 0.5% (w/v) dilution of test material in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water
One week later, the shoulder region was clipped again and treated with a topical application of the test material formulation (50% w/w in distilled water). the test material formulation (0.2 - 0.3 mL) was applied on filter paper (WHATMAN No. 4: approximate size 40mm X 20 mm) which was held in place with two strips of waterproof adhesive strapping (SLEEK) in the form of a cross and covered with an overlapping length of aluminium foil. The patch and foil were further secured by a strip of elastic adhesive bandage (ELASTOPLAST: approximate size 250 mm X 35 mm) wound in a double layer around the torso of each animal. This occlusive dressing was kept in place for 48 hours.
2) Control animals:
Intradermal injections were administered using an identical procedure to that used for the test animals, except that the injections were:
i) Freund's Complete Adjuvant plus distilled water in the ratio 1:1.
ii) Distilled water
iii) Freund's Complete Adjuvant plus distilled water in the ratio 1:1.
The topical applications followed the same procedure as for the test animals except that the vehicle alone was applied to the filter paper.
B. CHALLENGE EXPOSURE
Two weeks after the topical inductions, an area, approximately 50 - 70 mm X 50 mm on both flanks of each animal, was clipped free of hair with veterinary clippers.
A quantity of 0.1 - 0.2 mL of the test material formulation (50% w/w in distilled water) was applied to the shorn right flank of each animal on a 20 mm X 20 mm square of filter paper (WHATMAN No.4) which was held in place by two strips of waterproof adhesive strapping (SLEEK) in the form of a cross. The vehicle alone was similarly applied to the left shorn flank. The patches were occluded with an overlapping length of aluminium foil and secured by a strip of elastic adhesive bandage (ELASTOPLAST: approximate size 250 mm X 75 mm) wound in a double layer around the torso of each animal.
After 24 hours, the dressing was carefully cut using blunt-tipped scissors, removed and discarded. the position of the sites were identified by using a black indelible pen. After a further 24 and 48 hours, any erythematous reactions were quantified using a slightly modified Magnusson and Kligman scale.
OBSERVATIONS:
The bodyweight of each animal was recorded at the start and end of the study. - Challenge controls:
- Vehicle control group: distilled water
10 females were used in the vehicle control group. - Positive control substance(s):
- yes
- Remarks:
- The strain used in these laboratories has been shown to produce a satisfactoy sensitisation response using positive sensitisers (NOTE: it was not stated in the study report which positive sensitisers were tested or when the last test was conducted).
Study design: in vivo (LLNA)
- Statistics:
- no data
Results and discussion
- Positive control results:
- The strain used in these laboratories has been shown to produce a satisfactory sensitisation response using positive sensitisers.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% (w/w) of the test material in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No adverse skin reactions were observed at the test material site.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% (w/w) of the test material in distilled water. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No adverse skin reactions were observed at the test material site..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% (w/w) of the test material in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No adverse skin reactions were observed at the test material site.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% (w/w) of the test material in distilled water. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No adverse skin reactions were observed at the test material site..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No adverse skin reactions were observed at the vehicle control site.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: distilled water. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No adverse skin reactions were observed at the vehicle control site..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No adverse skin reactions were observed at the vehicle control site.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: distilled water. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No adverse skin reactions were observed at the vehicle control site..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50% (w/w) of the test material in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No adverse skin reactions were observed at the test material site.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50% (w/w) of the test material in distilled water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No adverse skin reactions were observed at the test material site..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% (w/w) of the test material in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No adverse skin reactions were observed at the test material site.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% (w/w) of the test material in distilled water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No adverse skin reactions were observed at the test material site..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No adverse skin reactions were observed at the vehicle control site.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: distilled water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No adverse skin reactions were observed at the vehicle control site..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No adverse skin reactions were observed at the vehicle control site.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: distilled water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No adverse skin reactions were observed at the vehicle control site..
Any other information on results incl. tables
OBSERVATIONS:
- Bodyweights: bodyweight gains of guinea pigs in the test group between day 0 and 24 were comparable to those in the control group over the same period.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material, Rezal 36 GP powder, was found to be a non-sensitiser to guinea pig skin.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not a skin sensitizer.
According to the EC-Regulation 1272/2008 and its subsequent amendments, the test item is not a skin 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.