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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
no further information on the test substance (stability, purity)
GLP compliance:
no
Remarks:
Several quality assurance inspections were carried out

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentapotassium bis(peroxymonosulphate) bis(sulphate)
EC Number:
274-778-7
EC Name:
Pentapotassium bis(peroxymonosulphate) bis(sulphate)
Cas Number:
70693-62-8
Molecular formula:
H3K5O18S4
IUPAC Name:
pentapotassium bis(peroxymonosulphate) bis(sulphate)
Details on test material:
- Name of test material (as cited in study report): RD/1/85
- Description: White powder
- Analytical purity: Not stated
- Composition of test material, percentage of components: Not stated
- Lot/batch No.: Not stated
- Stability under test conditions: Not stated

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: C. and J. Morton Ltd., Parsonage Farm, England
- Age at study initiation: 3 months
- Weight at study initiation: 3.42 – 3.48 kg
- Sex: Not stated

Test system

Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g
- Preparation of test substance: Not stated


Duration of treatment / exposure:
Animals were sacrificed on day 2 (eyes were not rinsed throughout the entire study period).
Observation period (in vivo):
Both eyes of each animal were examined on the day before administration for signs of pre-existing irritation, reaction or abnormality which eliminate it from the study.
Ocular reactions to treatment were assessed 1 and 24 h after treatment.
Number of animals or in vitro replicates:
3 per group
Details on study design:
CONTROL

The left eye of each rabbit remained untreated and served as control.


SCORING SYSTEM:

Scoring of ocular lesions (cornea, iris, conjunctivae and chemosis) was according to grading listed in OECD guideline 405.
Additionally assessed were:
- pain response:
No response: 0 (no initial pain)
A few blinks only; normal within one or to minutes: 1 (practically no initial pain)
Rabbit blinks and tries to open eye but reflexes close it: 2 (slight initial pain)
Rabbit holds eye shut and puts pressure on lids, may rub eye with paw: 3 (moderate initial pain)
Rabbit holds eye shut vigorously, may squeal: 4 (severe initial pain)
Rabbit holds eye shut vigorously, may squeal, claw at eye and try to escape: 5 (very severe initial pain)
- ocular lesions:
Cornea
Area of cornea affected by lesion
One-quarter or less, but not zero: 1
Greater than one-quarter, less than one-half: 2
Greater than one-half, less than three-quarters: 3
Greater than three-quarters, up to whole area: 4

Conjunctivae:
Discharge
No discharge: 0
Any amount different from normal (does not include small amounts observed in inner canthus of normal animals): 1
Discharge with moistening of the lids and hairs just adjacent to the lids: 2
Discharge with moistening of the lids and hairs and affecting a considerable area around the eye: 3

Interpretation of results:
A substance or preparation is considered irritant if, when applied to the eye of the animals, significant ocular lesions are caused which are present 24 h or more after instillation of the test material.
Ocular lesions are considered significant if two or more of the rabbits have mean values at or above the limit values following:
corneal opacity: 2
iris lesions: 1
redness of conjunctivae: 2.5
Chemosis: 2
(The Official Journal of the European Communities, L257/8, Vol. 26, 16/9/83 and L257/19, Vol. 26, 16/9/83)


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
animal #1
Remarks:
12TP 677
Time point:
other: 24 hrs
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
, see "Remarks on results..."
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
animal #2
Remarks:
12TP 678
Time point:
other: 24 hrs
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
, see "Remarks on results..."
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
animal #3
Remarks:
12TP 680
Time point:
other: 24 hrs
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
, see "Remarks on results..."
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
mean
Time point:
other: 24 hrs
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
, see "Remarks on results..."
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
12TP 677
Time point:
other: 24 hrs
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
12TP 678
Time point:
other: 24 hrs
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
12TP 680
Time point:
other: 24 hrs
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hrs
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
12TP 677
Time point:
other: 24 hrs
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks:
, see "Remarks on results..."
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
12TP 678
Time point:
other: 24 hrs
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks:
, see "Remarks on rseults..."
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
12TP 680
Time point:
other: 24 hrs
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks:
, see "Remarks on results..."
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
other: 24 hrs
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks:
, see "Remarks on results..."
Irritation parameter:
conjunctivae score
Remarks:
(chemosis)
Basis:
animal #1
Remarks:
12TP 677
Time point:
other: 24 hrs
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
, see "Remarks on results..."
Irritation parameter:
conjunctivae score
Remarks:
(chemosis)
Basis:
animal #2
Remarks:
12TP 678
Time point:
other: 24 hrs
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
, see "Remarks on results..."
Irritation parameter:
conjunctivae score
Remarks:
(chemosis)
Basis:
animal #3
Remarks:
12TP 680
Time point:
other: 24 hrs
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
, see "Remarks on results..."
Irritation parameter:
conjunctivae score
Remarks:
(chemosis)
Basis:
mean
Time point:
other: 24 hrs
Score:
2.7
Max. score:
4
Reversibility:
not reversible
Remarks:
, see "Remarks on results..."
Irritant / corrosive response data:
not indicated
Other effects:
not indicated

Any other information on results incl. tables

Clinical signs:

Not stated

Average score:

Please refer to tables 1 to 4

Cornea: Average score of all animals at 24 h was 3.0

Iris: Average score of all animals at 24 h was 0.0

Conjunctiva:Please refer to tables 2 to tables 4

Redness: Average score of all animals at 24 h was 3.0

Chemosis:Average score of all animals at 24 h was 2.7

Reversibility: No

Observed changes were considered to be due to necrosis, and consequently the study was terminated and the animals were killed on humane reasons 24 h after treatment.

Overall result:

Instillation of RD/1/85 into the conjunctival sac of three rabbits caused severe ocular lesions which were apparent in all animals within 1 h.

Principal changes included nacreous areas of opacity covering the whole of the cornea, a beefy-red appearance to the conjunctivae, marked chemosis and a creamy white ocular discharge. In addition, the lower conjunctival and nictitating membranes of all rabbits and one third of the one rabbit appeared white. It was considered that theses latter changes were due to necrosis, and consequently the study was terminated and the animals killed.

Instillation of the test material caused practically no initial pain responses in all animals.

Table 1: Values for ocular lesions 24 h after single ocular instillation of 0.1 g KMPS triple salt

Animal No.

Corneal opacity

Iridial lesions

Redness of Conjunctiva

Chemosis

12TP677

3.0

0.0

3.0

3.0

12TP678

3.0

0.0

3.0

3.0

12TP680

3.0

0.0

3.0

2.0

Table 2:  Grades for ocular irritation responses following instillation of 0.1 g KMPS triple salt
(animal 12TP 677, pain evaluation response: 1)

-

-

Grade of response at time after instillation

Region of the eye

Response

1 h

24 h

Cornea

      Opacity

3

3

"

      Area

4

4

"

      Ulceration

-

-

"

      Stippling

-

-

Iris

       Value

0

0

Conjunctiva

      Redness

1B

3

"

      Chemosis

2

3

"

      Discharge

1

3C

"

      Necrosis

-

-

"

      Ulceration

-

-

B    Lower conjunctival membranes and nictitating membrane whitened

C    Discharge white and creamy

Table 3:  Grades for ocular irritation responses following instillation of 0.1 g KMPS triple salt
(animal 12TP 678, pain evaluation response: 1)

-

-

Grade of response at time after instillation

Region of the eye

Response

1 h

24 h

Cornea

      Opacity

3

3

"

      Area

3

4

"

      Ulceration

-

-

"

      Stippling

-

-

Iris

       Value

0

0

Conjunctiva

      Redness

1B

3

"

      Chemosis

2

3

"

      Discharge

1

3C

"

      Necrosis

-

-

"

      Ulceration

-

-

B    Lower conjunctival membranes and nictitating membrane whitened

C    Discharge white and creamy

Table 4:  Grades for ocular irritation responses following instillation of 0.1 g KMPS triple salt
(animal 12TP 680, pain evaluation response: 1)

-

-

Grade of response at time after instillation

Region of the eye

Response

1 h

24 h

Cornea

      Opacity

4

3D

"

      Area

1

4D

"

      Ulceration

-

-

"

      Stippling

-

-

Iris

       Value

1

0

Conjunctiva

      Redness

1B

3

"

      Chemosis

2

2

"

      Discharge

1

3C

"

      Necrosis

-

-

"

      Ulceration

-

-

B    Lower conjunctival membranes and nictitating membrane whitened

C    Discharge white and creamy

D    Area white

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information with potential to cause severe damage to the eye Criteria used for interpretation of results: EU
Conclusions:
The study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability). Under the conditions of this test, KMPS triple salt was classified as irritant with potential to cause severe damage to the eye (Xi, R41) according to the criteria of Directive 67/548/EC (DSD) and eye damage cat. 1 (causes severe eye damage) according to Regulation 1272/2008/EC.
However, since KMPS triple salt was classified as corrosive and assigned R34, the risk of severe damage to eyes is considered implicit and R41 is not included in the label of KMPS triple salt.
Executive summary:

Materials and methods

This study was performed to assess acute eye irritation effects of KMPS triple salt in rabbits.

A quantity of 0.1 g of the test substance was instilled into the right eye of each of three healthy NZW rabbits. Ocular irritation was evaluated 1, and 24 h after instillation of the test substance.

Results and discussion

Please refer to tables 1 to 4, which are presented under “Remarks on results including tables and figures”.

Instillation of KMPS triple salt into the conjunctival sac of three rabbits caused severe ocular lesions which were apparent in all animals within 1 h and justified the termination of the test on humane ground, 24 h after treatment.

Principal changes included nacreous areas of opacity covering the whole of the cornea, a beefy-red appearance to the conjunctivae, marked chemosis and a creamy white ocular discharge. In addition, the lower conjunctival and nictitating membranes of all rabbits and one third of the one rabbit appeared white. It was considered that these latter changes were due to necrosis, and consequently the study was terminated and the animals killed.

Instillation of the test material caused practically no initial pain responses in all animals.

The values for ocular lesions recorded 24 h after treatment exceeded the limit values for classifying the test material as irritant to the eyes.