Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

method of the U.S. Federal Register, §191.12, 17 September 1964

Deviations:

not applicable

GLP compliance:

no

Remarks:

Study was performed under the control of a quality assurance unit similar to GLP

Test material

Test material information

Constituent 1

Reference substance name:

Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)

EC Number:

279-013-0

EC Name:

Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)

Cas Number:

78948-87-5

Molecular formula:

C16H8MgO10.2H

IUPAC Name:

Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)

Details on test material:

Test material: Magnesium-monoperoxyphthalate-hexahydrate, H48 Bleach
- Source and lot/batch No.of test material: 0525
- Further relevant properties: White powder with a faint pungent odour

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Ranch Rabbits, Crawley Downi, Sussex
- Age at study initiation: 6 month
- Weight at study initiation: 4.08 - 5.60 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16+/-2
- Humidity (%): 50-70
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light): 10/14

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Observation period (in vivo):

24, 48 and 72 h, 8 d

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
criteria of Draize as required by the U.S. Federal Register, §191.12, 17 September 1964

TOOL USED TO ASSESS SCORE: not reported

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

2.6

Max. score:

3

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

1.1

Max. score:

2

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

2.4

Max. score:

3

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

redness

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

2.7

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Reevaluation of data presented in the report was performed in year 1994.

A single instillation of 100 mg H 48 bleach caused marked irritation of the cornea and conjunctiva of all rabbits, and of the iris of three animals, 24 hours later. At that time corneal lesions ranged from easily discernible translucent areas to nacreous areas obscuring the iris and affected areas ranging from less than a quarter up to the entire corneal surface . Conjunctival reaction consisted of diffuse crimson and, in one instance, beefy-redness, chemosis, ranging from obvious swelling with partial evers ion of the lids to complete closure, and was usually accompanied by some degree of ocular discharge.
These reactions occasionally intensified up to 72 hours after administration and all, except the iridial reaction of three rabbits, persisted at Day 8. The iridial reaction of the latter had resolved between 72 hours and seven days after administration. On Day 8 all animals presented pannus, which in one instance obscured the iris.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

H48 bleach showed severe irritation in the rabbit eye, when applied at doses of 100 mg. According to CLP GHS, H 48 bleach requires classification.

Executive summary:

The eye irritation study was conducted in year 1981and new assessed in year 1994.

All animals of each treatment group displayed slight or moderate initial pain responses on instillation of test material. Under the conditions of this assessment each of the three treatments elicited marked ocular irritation.

Therefore, the test item will be classified as eye irritant.