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EC number: 234-319-3 | CAS number: 11097-59-9
- 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

Endpoint summary
Administrative data
Description of key information
Read across from Alcamizer 5 (422-150-1) and Aluminium-magnesium-zinc-carbonate-hydroxide (EC 423-570-6).
Alcamizer 5:
Acute oral study (EEC-Directive 92/69 B.1, according to GLP principles): Alcamizer 5 has been tested in a gavage study. The LD50 was established to be > 2000 mg/kg.
Acute inhalation study (OECD 403 according to GLP principles): The LC50 was established to be > 5.16 mg/l (4 h exposure).
Dermal acute toxicity (EEC-Directive 92/69 B.3, according to GLP principles):
Alcamizer5 has been tested in a 24-hours, semi-occlusive study exposing 5 males and 4 females Wistar Crl: (WI)BR rat to 2000 mg/kg bw.
No mortality occurred and no clinical signs were observed. The LD50 was established to be > 2000 mg/kg bw.
Aluminium-magnesium-zinc-carbonate-hydroxide:
Acute oral study (EEC-Directive 92/69 B.1, according to GLP principles): Aluminium-magnesium-zinc-carbonate-hydroxide-(hydrate) has been
tested in a gavage study exposing 5 males and 5 females wistar rat to 2000 mg/kg bw. No mortality occurred and no clinical signs were observed. The LD50 was established to be > 2000 mg/kg bw.
Acute inhalation study (OECD 403 according to GLP principles):
Aluminium-magnesium-zinc-carbonate-hydroxide-(hydrate) has been tested in a nose only study exposing for 4-hours 5 males and 5 females
wistar rat to a concentration of 5.17 mg/l. No mortality occurred. Slight visually decreased breathing rate in all animals during the first two hours,
aggravating to moderate decreased breathing rate in the last two hours. Findings at necropsy were limited to discouraging of the lungs seen in three
animals. The LC50 was established to be > 5.17 mg/l.
Supporting study:
single dose toxicity study: [carbonato(2-)]hexadecahydroxybis(aluminium)hexamagnesium caused no mortality when administered orally, subcutaneously or intraperitoneally, to male mice up to a dose level of 10 gram/kg.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study performed in accordance with OECD guideline and in compliance with GLP guidelines. As the study is performed with a substance analogue, in accordance with REACH guidance the maximum reliability for read-across data is 2. Read-across is justified because of the similar chemical nature of the target substance compared to the analogues. The read-across rationale can be found in the analogue approach document attached in Section 13.
- Qualifier:
- according to guideline
- Guideline:
- other: EEC-Directive 92/69 B.1
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- other: Destilled water
- Doses:
- 2000 mg/kg (10 ml/kg) body weight
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: No mortality occurred and no clinical signs were observed.
- Gross pathology:
- Effects on organs:
No findings. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Comments:
none
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Study performed in accordance with OECD guideline and in compliance with GLP guidelines. As the study is performed with a substance analogue, in accordance with REACH guidance the maximum reliability for read-across data is 2. Read-across is justified because of the similar chemical nature of the target substance compared to the analogues. The read-across rationale can be found in the analogue approach document attached in Section 13.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study performed in accordance with OECD guideline and in compliance with GLP guidelines. As the study is performed with a substance analogue, in accordance with REACH guidance the maximum reliability for read-across data is 2. Read-across is justified because of the similar chemical nature of the target substance compared to the analogues. The read-across rationale can be found in the analogue approach document attached in Section 13.
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for Testing of Chemicals no. 403, adopted 12 May, 1981.
- GLP compliance:
- yes
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: none used
- Details on inhalation exposure:
- nose only
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5.16 +/- 0.48 g/m3
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.16 mg/L air
- Exp. duration:
- 4 h
- Mortality:
- Male: 5.16 mg/L; Number of animals: 5; Number of deaths: 0
Female: 5.16 mg/L; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: During exposure: Slight visually decreased breathing rate in all animals. After exposure: Cold upon touching (2M/1F) directly after exposure. Dirty fur of the head (2F) until day 7. Alopecic area
- Body weight:
- In general slightly reduced mean body weight gain was seen seven days after exposure.
- Gross pathology:
- Macroscopic:
Sparsely haired abdomen (1F). - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5.16 mg/m³ air
- Quality of whole database:
- Study performed in accordance with OECD guideline and in compliance with GLP guidelines. As the study is performed with a substance analogue, in accordance with REACH guidance the maximum reliability for read-across data is 2. Read-across is justified because of the similar chemical nature of the target substance compared to the analogues. The read-across rationale can be found in the analogue approach document attached in Section 13.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study performed in accordance with OECD guideline and in compliance with GLP guidelines. As the study is performed with a substance analogue, in accordance with REACH guidance the maximum reliability for read-across data is 2. Read-across is justified because of the similar chemical nature of the target substance compared to the analogues. The read-across rationale can be found in the analogue approach document attached in Section 13.
- Qualifier:
- according to guideline
- Guideline:
- other: EEC-Directive 92/69 B.3
- GLP compliance:
- yes
- Limit test:
- yes
- Species:
- rat
- Type of coverage:
- semiocclusive
- Vehicle:
- corn oil
- Duration of exposure:
- 24 h
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 4; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: No findings.
- Gross pathology:
- Effects on organs:
No findings. - Other findings:
- Signs of toxicity (local):
Erythema, scales and scabs were seen (4F) during the
observation period. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Study performed in accordance with OECD guideline and in compliance with GLP guidelines. As the study is performed with a substance analogue, in accordance with REACH guidance the maximum reliability for read-across data is 2. Read-across is justified because of the similar chemical nature of the target substance compared to the analogues. The read-across rationale can be found in the analogue approach document attached in Section 13.
Additional information
Based on studies performed on Aluminium-magnesium-zinc-carbonate-hydroxide as well as on Alcamizer 5 and a supporting study on [carbonato(2-)]hexadecahydroxybis(aluminium)hexamagnesium, it can be concluded that [carbonato(2-)]hexadecahydroxybis(aluminium)hexamagnesium is not considered toxic via dermal, oral or inhalation route, in acute toxicity tests.
EC # |
423-570-6 |
422-150-1 |
234-319-3 |
Name |
P93 |
Alcamizer 5 |
Magnesium-Aluminium- Hydroxide-Carbonate |
Acute oral (LD50) [mg/kg bw] |
> 2000 |
> 2000 |
read-across: > 2000 |
Acute dermal (LD50) [mg/kg bw] |
no data |
> 2000 |
read-across: > 2000 |
Acute inhalation [mg/L] |
> 5.17 |
> 5.16 |
read-across: > 5.16 |
Justification for selection of acute toxicity – oral endpoint
The analogue P93 show minimal acute toxicity resulting in oral LD50 >2000 mg/kg bw.
Justification for selection of acute toxicity – inhalation endpoint
The analogue Alcamizer 5 show minimal acute toxicity resulting in LC50 >5.16 mg/L air.
Justification for selection of acute toxicity – dermal endpoint
The analogue Alcamizer 5 show minimal acute toxicity resulting in dermal LD50 >2000 mg/kg bw.
Justification for classification or non-classification
Based on the results of the studies performed with substance analogues, the substance does not have to be classified for acute toxicity according to Regulation (EC) No 1272/2008 .
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.

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