Registration Dossier

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:
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 group
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 group
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.