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EC number: 234-933-1 | CAS number: 12042-91-0
- 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:
- 29 September 1998 - 30 October 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study was performed according to OECD guideline 406 and under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1996
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- At the time of study completion (1998), the LLNA OECD test method was not adopted.
Test material
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Aluminiumhydroxichlorid
- Physical state: Solid
- Analytical purity: Confidential information
- Purity test date: Confidential information
- Lot/batch No.: Confidential information
- Expiration date of the lot/batch: Confidential information
- Stability under test conditions: Guaranteed for 4 hours
- Storage condition of test material: Darkness at room temperature in a fume cupboard
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann
- Age at study initiation: No data
- Weight at study initiation: 330-398 g (mean: 359 g)
- Housing: In groups of 5 animals
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum, tap water in plastic bottles
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 5
- Humidity (%): 50 +/-20
- Air changes (per hr): Fully airconditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Remarks:
- deionized water
- Concentration / amount:
- 0.2%
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Concentration / amount:
- 25%
- Day(s)/duration:
- Day 8 / 48 hours
- Adequacy of induction:
- other: maximum concentration tested / No signs of skin irritation observed in the sighting study
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- deionized water
- Concentration / amount:
- 25%
- Day(s)/duration:
- Day 22 / 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Control: 5
Treatment: 10 - Details on study design:
- RANGE FINDING TESTS:
1. Primary non-irritant concentration:
Prior to the determination of the primary non-irritation concentration in a dermal-occlusive test the animals received 4 intradermal injections of a 50% FCA emulsion (4x0.1 ml) into the dorsal area, since FCA may lower the threshold of primary irritation. Thereafter, each of the followig test concentrations was administered to the flanks of two guinea pigs: 25%, 5% and 1% in deionized water.
Hair of the flanks of the animals was removed mechanically. 0.5 ml of the test substance preparation was administered to a 2x2 cm cellulose patch, which was fixed to the flank and covered occlusively for 24 hours with a bandage and film. 24 hours after removal of the patches, the treated skin areas were examined for erythema and oedema.
2. To determine the tolerance of intradermal injections, each of the following preparations was administered twice by intradermal injection to 2 guinea pigs. The injection-sites were all within a dorsal area measuring 2x4 cm in the vicinity of the shoulders. 24, 48, 72 and 96 hours after administration the injection sites were examined for local tolerance.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal + epicutaneous)
- Exposure period:
Intradermal: Day 1
Epicutaneous: Day 8-10 (48 hours)
- Test groups: 1 (10 animals)
- Control group: 1 (5 animals)
- Site: Dorsal area of 2x4 cm
- Frequency of applications: Once (intradermal and epicutaneous)
- Concentrations:
Intradermal: 0.2%
Epicutaneous: 25%
Exposure according to guideline.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: Day 22
- Exposure period: 24 hours
- Test groups: 1 (10 animals)
- Control group: 1 (5 animals)
- Site: Left flank area of 5x5 cm (shaved)
- Concentrations: 25% in deionized water on a 2x2 cellulose patch
- Evaluation (hr after challenge): 24 and 48 hours after removal of patches erythema and oedema were evaluated.
OTHER:
- Body weight recorded at day 0 and 25 of study (beginning and end) - Challenge controls:
- Not relevant
- Positive control substance(s):
- yes
- Remarks:
- Benzocain was tested in study no 98.0293 (ID induction: 1% benzocain in sesame oil DAB 10 ; dermal induction and challenge: 25% benzocain in sesame oil DAB 10)
Results and discussion
- Positive control results:
- After the second challenge treatment four animals (40%) showed a positive reaction during the observation period.
The results obtained are typical for weak sensitizers.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% Aluminiumhydroxychlorid
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin reactions
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- deionized water
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No skin reactions
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% Aluminiumhydroxychlorid
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin reactions
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- deionized water
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No skin reactions
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Group:
- positive control
- Dose level:
- 25% benzocain in sesame oil DAB 10
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Primary irritant concentration
No signs of irritation occurred after administration of the different test concentrations. Based on these results, a concentration of 25% test article in deionized water was chosen for the challenge at day 22.
Tolerance of intradermal injections
The intradermal injections with the 5.0% and 1.0% preparation caused moderate erythema and oedema. Additionally encrustions and indurations were observed. Intradermal injections with the 0.2% preparation caused moderate up to well-defined erythema and oedema. Additionally indurations were observed. Based on this preliminary test, a 0.2% preparation was selected for the intradermal injections in the main test.
Main test
Body weight gains of the animals were not impaired. The treated animals showed no clinical signs of intoxication throughout the study.
Intradermal injections with FCA (with and without test article) caused severe erythema and oedema as well as indurations and encrustations. The administration sites treated with the test substance in deionized water showed well-defined erythema and oedema as well as indurations. Intradermal injections of the vehicle alone exhibited no signs of irritation.
Epicutaneous induction showed severe erythema and oedema, indurated, and encrusted skin as well as necrosis and open wounds after removal of the patches at day 10 previously treated with FCA. The administration sites treated with the test substance showed well-defined erythema and oedema. The administration sites treated with the vehicle alone showed no signs of irritation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this Guinea Pig Maximisation Test (OECD 406), Aluminiumhydroxychlorid did not induce any adverse skin reactions in the test group (sensitization rate: 0%). Therefore, the substance was not classified as a skin sensitizer according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In a Magnusson & Kligman maximisation study (GPMT) performed according to OECD Guideline 406 and in compliance with GLP, 10 guinea pigs were treated with Aluminiumhydroxychlorid, 5 animals were used as control group. Induction was done by intradermal (0.2%) and epicutaneous administration (50%), after that the animals were challenged by epicutaneous administration (50%). Body weights were measured before and after study.
None of the ten animals of the treatment group showed a positive skin reaction after 24 and 48 hours. No reactions were observed in the control group.
The results indicate a sensitization rate of 0% (0/10), which is below the threshold of 30%. Therefore, Aluminiumhydroxychlorid does not need to be classified as a sensitizing substance according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
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