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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation
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.6 Maximization method
GLP compliance:
yes
Species:
guinea pig
Strain:
Himalayan
Sex:
female
Route:
intradermal
Vehicle:
water
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal injection: 5% in distilled water

Epidermal application: 50% in distilled water

Concentration of test material and vehicle used for each challenge:
50% in distilled water
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal injection: 5% in distilled water

Epidermal application: 50% in distilled water

Concentration of test material and vehicle used for each challenge:
50% in distilled water
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0.

Maximum concentration not causing irritating effects in preliminary test: 50 %

Signs of irritation during induction:

After intradermal injection:

On day 3 moderate/severe erythema (grade 1 or 2) was observed in all animals (experimental). On day 10 1/10
animals showed small scabs.

Evidence of sensitisation of each challenge concentration:
The results lead to a sensitization rate of 0%.

Other observations:
none

Interpretation of results:
not sensitising
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Based on studies performed on Aluminium-magnesium-zinc-carbonate-hydroxide as well as on Alcamizer 5, both analogue substances, it can be concluded that [carbonato(2-)]hexadecahydroxybis(aluminium)hexamagnesium is not a skin sensitizer.

EC #

423-570-6

422-150-1

Name

P93

Alcamizer5

Skin sensitisation

Not sensitizing

Not sensitizing


Migrated from Short description of key information:
Read across from Alcamizer 5 (EC no: 422-150-1) and Aluminium-magnesium-zinc-carbonate-hydroxide (EC no: 423-570-6).

Alcamizer5:
GPMT preliminary study performed according to EEC-Directive 92/69 B.6 Maximization method and GLP: not classified.
GPMT main study performed according to 92/69/EC, Annex V B6 and OECD 406 and GLP: not classified.

Aluminium-magnesium-zinc-carbonate-hydroxide:
Study performed according to EEC-Directive 92/69 B.6 Maximization method and GLP: result not sensitizing

Justification for selection of skin sensitisation endpoint:
The analogue P93 showed no skin sensitization.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

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 sensitization according to Regulation (EC) No 1272/2008.