Reaction mass of calcium sulfate and potassium sulfate and sodium sulphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From 12.03.1991 To 19.03.1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to OECD Guideline 405 and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sulfuric acid disodium salt

IUPAC Name:

Sulfuric acid disodium salt

Constituent 2

Reference substance name:

Sodium sulphate

EC Number:

231-820-9

EC Name:

Sodium sulphate

Cas Number:

7757-82-6

Molecular formula:

Na2SO4

IUPAC Name:

disodium sulfate

Details on test material:

- Name of test material (as cited in study report): Natriumsulfat (Merck AG, Darmstadt)
- Physical state: sold (white powder)
- Analytical purity: 99.4 %
- Lot/batch No.: 711 TA 290843
- Expiration date of the lot/batch: no data
- Stability under test conditions: guaranted for the study period
- Storage condition of test material: room temperature, to avoid humidity

Test animals / tissue source

Species:

rabbit

Strain:

other: HC:NZW

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: breeder Interfauna U.K. Ltd, Wyton, Huntingdon
- Age at study initiation: no data
- Weight at study initiation: 3.3-3.5
- Housing: individually housed in stainless steel cages
- Diet: Standard diet "Ssniff K 4" (Ssniff Spezialdiäten Gmbh, Soest), approx. 100 - 120 g per animal/day; once per day in the morning.
- Water: tap water; ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): approx. 45
- Air changes (per hr): 18
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the other eye remained untreated and served as control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): a volume of 100 µl of the pulverized test substance - equivalent to approx. 90 mg -.

Duration of treatment / exposure:

24 hours.

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was rinsed with saline.
- Time after start of exposure: 24 hours

SCORING SYSTEM: The signs of cornea (opacity and area affected), iris (hyperaemia, reaction to light), conjunctivae - i.e. conjunctiva of bulbus, lids, and nictitating membrane - (erythema, chemosis), and discharge were recorded as described by DRAIZE (see below)

A) Cornea
Opacity; Decrree of density (area most dense taken for reading)
Value
- no ulcération or opacity 0
- scattered or diffuse areas of opacity (other than slight dulling of normal lustre) détails of iris clearly visible 1
- easily discernible translucent area, détails of iris slightly obscured 2
- nacreous area, no détails of iris visible, size of pupil barely discernible 3
- completely opaque cornea, iris not discernible through the opacity 4

B) Iris
- normal 0
- markedly deepened rugae, congestion, swelling, moderate circumcorneal hyper-aemia, or injection,
any of these or combination of any of thereof, iris still reacting to light (sluggish reaction is positive). 1
- no reaction to light, haemorrhage, gross destruction (any or ail of thèse) 2

C) Conjunctivae: Erythema (redness)
- blood vessels normal 0
- some blood vessels definitely hyperaemic (injected) 1
- diffuse, crimson colour, individual vessels not easily discernible 2
- diffuse, beefy redness 3

D) Conjunctivae: Chemosis: lids and/or nictitating membranes
- no swelling 0
- any swelling above normal
(includes nictitating membranes) 1
- obvious swelling with partial eversion
of lids (ectropium) 2
- swelling with lids about half closed 3
- swelling with lids more than half closed 4



TOOL USED TO ASSESS SCORE: The examinations of cornea, iris and aqueous humour were failitated using hand-slit lamp. To define epithelial damage, one drop of a 1% fluorescein solution was applied to the corneal surface 24 hours after administration of the test substance.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The results indicate that the test substance induced slight irritation to the eye.

Other effects:

None reported.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test.

Score at time point/ reversibility	Iris Max. Score: 2	Cornea Max. Score: 4	Conjunctivae Max. Score: 3	Chemosis Max. Score: 4
1h	0/0/0	0/0/0	2/2/1	1/0/0
24h	0/0/0	0/0/0	2/2/1	0/0/0
48h	0/0/0	0/0/0	1/1/1	0/0/0
72h	0/0/0	0/0/0	0/1/0	0/0/0
7d	0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	0	0	1	0
Reversibility *)	-	-	C.	C.
Average time (unit) for reversion	-	-	7 (days)	24 (hours)

*) Reversibility: c.= completely reversible; n.c. = not completely reversible; n. = not reversible.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this test, the test substance induced a slight irritation to the eye.

Executive summary:

In an eye irritation study (Bayer, 1991), healthy adult albino rabbits, strain HC:NZW were exposed to a volume of 100 µl (equivalent to approx. 90 mg) of the pulverised test substance for 24 hours into the conjunctival sac of one eye of each of three rabbits. The lids were then gently held together for about one second in order to limit loss of material. The other eye remained untreated and served as control. Twenty four hours after instillation of the test substance the treated eye was rinsed with saline. In this study, the results indicate that the test substance may be regarded as 'slightly irritating to the eye'.