Magnesium acrylate

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guidline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

nulliparous, non pregnant
TEST ANIMALS
- Source: TOXI-COOP ZRT, H-1103, Budapest, Cserkesz u. 90
- Age at study initiation: 8 -11 weeks
- Weight at study initiation: 15.7 -20.6 g
- Housing: 4 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 or 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+- 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

other: aqueous 1% Pluronic PE9200

Concentration:

- three groups received the Magnesium acrylate solution at 99%, 50% or 25%
- the negative control group received the vehicle (aqueous 1% Pluronic PE9200) only,
- the positive control received 25% alpha-Hexylcinnamaldehyde (HCA),
- the negative control group for the positive control group received aceton: olive oil 4:1 (v/v)

No. of animals per dose:

four

Details on study design:

RANGE FINDING TESTS:
- Compound solubility: some precipitation on the skin of the ear
- Irritation: no
- Lymph node proliferation response: no

On the basis of a pilot study a formulation of the test item with 1% Pluronic PE9200 was chosen so t
hat the test item was sufficiently applicable on the ears of the animals.

Each concentration was applied on the external surface of each ear (25 μl/ear) of the animals for three co
nsecutive days (day1, 2, 3).
There was no treatment on days 4, 5 and 6. On day 6, the cell proliferation in the local lymph nodes
was measured by determing incorporation of tritiated methyl thymidine and the obtained values were
used to calculate stimulation indices.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Positive control results:

Larger lymph nodes and a higher stimulation index than the control were observed in the positive control group.

Parameter:

SI

Remarks on result:

other: negative control: 1.0, positive control: 14.2, 99% test item: 0.7, 50% test item: 0.3, 25% test item: 0.9, negative control: 1.0

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: negative control: 619/node, positive control: 8790.9/node, 99% test item: 239.6/node, 50% test item: 107.9/node, 25% test item: 326.4/node, negative control: 344.8/node

Parameter:

SI

Value:

0.7

Test group / Remarks:

test item conc. of 99%

Parameter:

SI

Value:

0.3

Test group / Remarks:

test item conc. of 50%

Parameter:

SI

Value:

0.9

Test group / Remarks:

test item conc. of 25%

No significant loss of body weight was observed in any treatment group.

No mortality, no obvious signs of systemic toxicity or irritation were observed in any treatment groups.

Loss of hair was observed in the 99% dose group from day1 to day 5.

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

Under the conditions of the present Local Lymph Node Assay the magnesium acrylate solution of 46.41% content tested at the maximum attainable concentration of 99% and at concentrations of 50% and 25% as homogenous formulations in aqueous 1% Pluronic, was shown to have no
sensitization potential (non-sensitizer).

Executive summary:

A formulation of 46.41 % Magnesium acrylate in water was supplied by the sponsor for testing the sensitization potential. On the basis of a pilot study a formulation of the test item with 1% Pluronic PE9200 (w/v) was chosen so that the test item was sufficiently applicable on the ears of the animals. In the main assay 24 female CBA/Ca mice were allocated to six groups of four animals each:

- three groups received the Magnesium acrylate solution at 99%, 50% or 25% (v/v),

- the negative control group received the vehicle (aqueous 1% Pluronic PE9200) only,

- the positive control received 25% alpha-Hexylcinnamaldehyde (HCA),

- the negative control group for the positive control group received aceton: olive oil, 4:1 (v/v).

Each substance was applied on the external surface of each ear (25 µl/ear) of the animals for three consecutive days (day1, 2, 3). There was no treatment on days 4, 5 and 6. On day 6, the cell proliferation in the local lymph nodes was measured by determing incorporation of tritiated methyl thymidine and the obtained values were used to calculate stimulation indices:

negative control: 1.0,

positive control: 14.2,

99% test item: 0.7,

50% test item: 0.3,

25% test item: 0.9,

negative control: 1.0.

No significant loss of body weight was observed in any treatment group.

No mortality, no obvious signs of systemic toxicity or irritation were observed in any treatment groups.

Loss of hair was observed in the 99% dose group from day 1 to day 5.

Under the conditions of the present Local Lymph Node Assay the magnesium acrylate solution of 46.41% content tested at the maximum attainable concentration of 99% and at concentrations of 50% and 25% as homogenous formulations in aqueous 1% Pluronic PE9200, was shown to have no sensitization potential.

Thus magnesium acrylate is a non-sensitizer.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Migrated from Short description of key information:
Under the conditions of a Local Lymph Node Assay (OECD Guideline 429) the magnesium acrylate solution of 46.41% content tested at the maximum attainable concentration of 99% and at concentrations of 50% and 25% as homogenous formulations in aqueous 1% Pluronic PE9200, was shown to have no sensitization potential.
Thus magnesium acrylate is a non-sensitizer.

Justification for selection of skin sensitisation endpoint:
key study

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available LLNA study, magnesium acrylate is a non-sensitizer and does not need to be classified and labelled according to

EC regulation 1272/2008, EEC Directives 67/548 and 1999/45.