Registration Dossier

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
Reference
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:
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:
Signs of toxicity related to dose levels:
No mortality occurred and no clinical signs were observed.
Gross pathology:
Effects on organs:
No findings.

Comments:
none

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
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
Reference
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:
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
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
5.16 mg/m³
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
Reference
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:
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:
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
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 .