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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guidline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
magnesium diacrylate
EC Number:
227-177-9
Cas Number:
5698-98-6
Molecular formula:
C3H4O2.1/2Mg
IUPAC Name:
magnesium diacrylate
Test material form:
other: aqueous solution of magnesium acrylate, 46.41%, pH: 6.4
Details on test material:
Aqueous solution of magnesium acrylate,
pH: 6.4
Composition: 46.41% magnesium diacrylate
Purity (based on 100%): 99.7%
Production date: 18.11.2011
Expiry date: 18.05.2012
Storage: room temperatur, keep away from light

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Quartier Labaste, F40260 Linxe
- Age at study initiation: 11/12 weeks
- Weight at study initiation: 2.41 - 3.44 kg
- Housing: individual box
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): app. 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
three
Details on study design:
REMOVAL OF TEST SUBSTANCE: no

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible within: 1-14 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Executive summary:

The test item Magnesium acrylate solution, 46.41%, was instilled as supplied, into one eye of each of three New Zealand rabbits at a dose of 0.1 ml. Ocular examinations were performed on both right and left eyes one hour and 24, 48 and 72 hours after treatment.

The occular reactions observed during the study have been slight to important and totally reversible in the three animals:

-at the conjunctivae level: a moderate to important redness noted 1 hour after the test item instillation and totally reversible between

days 3 and 14,

- moderate chemosis noted 1 hour after the test instillation and totally reversible between days 1 and 2,

- at the iris level: a congestion, noted 1 hour after the test item instillation in one animal and totally reversible on day 1.

According to the criteria for classification, packing and labelling of dangerous substances and preparations in accordance with the EEC Directives 67/548, 2001/59 and 1999/45, the test item Magnesium acrylate solution (46.41%) does not have to be classified.

No symbol or risk phrase is required.

In accordance with the Regulation EC No. 1272/2008 on classification , labelling and packing of substances and mixtures,

the test item does not have to be classified. No signal word or hazard statement is required.