Registration Dossier

Administrative data

Description of key information

Read-across:
Alcamizer 5 (EC 422-150-1) and Aluminium-magnesium-zinc-carbonate-hydroxide (EC 423-570-6):
Skin irritation: Not irritating.
Eye irritation: Mildly irritating
DHT-4A:
Skin irritation:
Study performed according to OECD 404 and GLP guidelines. It was concluded that the substance is not irritating to skin.
Eye irritation
Eye stimulating effects were very slight, as all symptoms were eliminated within 48 hours.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
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.4
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: The substance was moistened with distilled water.
Controls:
no
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
Observations were made 1, 24, 48 and 72 hours after exposure.
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Other effects:
Exposure to the substance resulted in very slight erythema in the treated skin-area of one of the three animals, 1 hour after exposure only.
Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Aluminium-magnesium-zinc-carbonate-hydroxide is not irritating
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation
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.5
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
35 MG
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance. The irritation scores and a description of all other (local) effects were recorded.
Number of animals or in vitro replicates:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritant / corrosive response data:
Iridic irritation grade 1 was observed in two animals, 1 hour after instillation. The irritation of the conjunctivae consisted
of redness, chemosis and discharge and had resolved within 48 hours in one animal and within 72 hours after instillation in the other two animals.

P 93-201 was considered mildly irritating (M2) to the rabbit eye (Kay and
Calandra interpretation of the calculated maximum Draize score: 11.3).

Reversibility of any observed effect: Changes fully reversible within 3 days.
Other effects:
Remnants of the test substance were present in the eyes and
on the outside of the eyelids of all animals on day 1.

P 93-201 was considered mildly irritating (M2) to the rabbit eye (Kay and

Calandra interpretation of the calculated maximum Draize score: 11.3).

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

For details see specific end point study record. All information indicated that hydrotalcite-like compounds are not irritating to skin and slightly irritating to the eye. [carbonato(2-)]hexadecahydroxybis(aluminium)hexamagnesium does not cause eye irritation leading to classification of the substance.  

EC #

423-570-6

422-150-1

234-319-3

Name

P93

Alcamizer 5

Magnesium-Aluminium-

Hydroxide-Carbonate

Skin irritation

not irritating

not irritating

read-across: not irritating

Eye irritation

mildly irritating

mildly irritating

read-across: not irritating

 


Justification for selection of skin irritation / corrosion endpoint:
The analogue P93 showed no irritation.

Justification for selection of eye irritation endpoint:
The analogue P93 showed mildly irritation but not sufficient for classification.

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 skin irritation or eye irritation according to Regulation (EC) No 1272/2008.