Sulfuric acid, mono-C9-12-alkyl esters, sodium salts

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1977-12-15 to 1978-03-10

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study performed before GLP was set into force.

Justification for type of information:

Refer to the Category Approach Justification document provided in IUCLID6 Section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

pre-GLP

Test material

Test material information

Constituent 1

Reference substance name:

91783-22-1 (purity 44%)

IUPAC Name:

91783-22-1 (purity 44%)

Details on test material:

- Name of test material (as cited in study report): KAS paste (Potassium alkyl sulphate) or B0010-01- Physical state: Solid- Analytical purity: 44% a.i.- Lot/batch No.: 763 - I'dale- Storage condition of test material: 21°C

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS- Source: Marland Breeding Farms, Inc- Age at study initiation: Not available- Weight at study initiation: Not available- Housing: animals were individually housed- Diet (e.g. ad libitum): Not available- Water (e.g. ad libitum): Not available- Acclimation period: Not availableENVIRONMENTAL CONDITIONS- Temperature (°C): Not available- Humidity (%): Not available- Air changes (per hr): Not available- Photoperiod (hrs dark / hrs light): Not availableIN-LIFE DATES: From: 1977-12-15 To: 1978-03-10

Test system

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.1 mL (eye non rinsed /rinsed)- Concentration (if solution): 50% w/w solution of test material in distilled water (22% a.i.)VEHICLE- Amount(s) applied (volume or weight with unit): Not applicable- Concentration (if solution): Not applicable- Lot/batch no. (if required): Not applicable- Purity: Not applicable

Duration of treatment / exposure:

Six rabbits were divided into two treatment groups: 0.1 ml of a 50% w/w solution of the test material (B0010) in distilled water was instilled into one eye each of three rabbits (Group I); a second group of three rabbits received the same treatment as group I, followed at 4 seconds by a 20 ml lukewarm tap water rinse (Group II).

Observation period (in vivo):

1 hour , and on days 1, 2, 3, 4, 7 ,14, 21 and 28 following compound administration.

Number of animals or in vitro replicates:

Group I - 3 animals (50% w/w solution of test material B0010 in distilled water, non-rinsed)Group II - 3 animals (50% w/w solution of test material B0010 in distilled water, rinsed)

Details on study design:

REMOVAL OF TEST SUBSTANCE- Washing (if done): Group I - Unwashed, Group II washing with 20 ml lukewarm tap water- Time after start of exposure: 4 seconds in group IISCORING SYSTEM: Draize Scoring SystemTOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: Day 1-3

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: Day 1-3

Score:

0.8

Max. score:

2

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: Day 1-3

Score:

2.1

Max. score:

3

Reversibility:

not fully reversible within: 21 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: Day 1-3

Score:

1.7

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Irritant / corrosive response data:

Group I (Unwashed eye)Overall irritation score at 1 hour: 6Overall irritation score at 1 day: 7.67Overall irritation score at 2 days: 6.67Overall irritation score at 3 days: 5.33Overall irritation score at 4days: 5.33Overall irritation score at 7 days: 3.33Overall irritation score at 14 days: 0.33Overall irritation score at 21 days: 0.66Group II (Washed eyes)Overall irritation score at 1 hour: 4.00Overall irritation score at 1 day: 6.34Overall irritation score at 2 days: 5.33Overall irritation score at 3 days: 4.33Overall irritation score at 4 days: 4.33Overall irritation score at 7 days: 1.66Overall irritation score at 14 days: 1.33Overall irritation score at 21 days: 0Overall irritation score at 28 days: 0

Other effects:

None

Any other information on results incl. tables

Irritation parameter	Basis	Time point		Max. score	Reversibility	Remarks
overall irritation score	mean	14 and 21 days		0.66	not fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, non rinsed
Cornea score and iris score	mean	14 and 21 days	0	0	othere: No corneal and iridal irritation was observed	0.1 ml of 50% w/w solution of test material in distilled water, non rinsed
conjunctivae and chemosis score	mean one animal with grade 1, two animals with grade 0	14 and 21 days	> = 0 -< = 1	1	not fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, non rinsed
overall irritation score	mean	1 hour		4.00	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
cornea score	mean three animals with grade 1	1 hour	1	1	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
Iris score	mean	1hour	0	0	other: no iridal irritation was observed	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
conjunctivae score	mean one animal with grade 1, two animals with grade 2	1 hour	> =1 -< =2	2	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
chemosis score	mean one animal with grade 2, two animals with grade 1	1 hour	> =1 -<=2	2	fully reversible within: 7 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
overall irritation score	mean	1 days		6.34	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
cornea score	mean one animal with grade 1, two animals with grtade 2	1 days	> = 1 - <=2	2	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
iris score	mean two animals with garde 1, one animal with grade 0	1, 2, 3 and 4 days	> =0 - <=1	1	fully reversible within: 7 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
conjunctivae score	mean two animals with grade 2, one animal with grade 3	1 and 2 days	> =2 - <=3	3	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
chemosis score	mean one animal grade 0, one animal with grade 2, one animal with grade 3	1 days	>=0 - <=3	3	fully reversible within: 7 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
overall irritation score	mean	2 days		5.33	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
cornea score	mean two animals with grade 2, one animal with grade 0	2, 3 and 4 days	>=0 -<=2	2	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
chemosis score	mean one animal with grade 0, one animal with grade1, one animal with grade 2	2 and 3 days	>= 0- <=3	3	fully reversible within: 7 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
overall irritation score	mean	3 and 4 days		4.33	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
conjunctivae score	mean two animals with grade 2, one animal with grade 0	3 and 4 days	>= 0 -<=2	2	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
overall irritation score	mean	7 days		1.66	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
cornea score	mean one animal with grade 0, one animal with grade 1, one animal with grade 3	7 days	>= 0 -<=3	3	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
iris score	mean	7 and 14 days	0	0	other : no iridal irritation was observed	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
conjunctivae score	mean one animal with grade 1, two animals with grade 0	7 and 14 days	>=0 -<=1	1	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
chemosis score	mean	7 and 14 days	0	0	other : no conjunctival chemosis was observed	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
overall irritation score	mean	14 days		1.33	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
cornea score	mean one animal with grade 0, one animal with grade 1, one animal with grade 3	14 days	>=0 - <=3	3	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
overall irritation, cornea, conjunctivae and chemosis score	mean	21 and 28 days	0	0	other : no ocular irritation was observed	0.1 ml of 50% w/w solution of test material in distilled water, rinsed

GHS Rating and Calculations

Animals no.	GHS Classification	What It means?	Cornea	Iris	Conjunctival redness	Conjunctival chemosis	Days to clear
354	2a	Irritating to eyes	2	0.67	2	1.67	21 days
355	2a	Irritating to eyes	2	0.67	2	1.33	21 days
356	2a	Irritating to eyes	2	1	2.33	2	21 days

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Regarding the fact that only one animal showed very slight effects on Day 28, a trigger for a classification as highly irritant is not justified. Hence, 22% a.s. potassium alkyl sulfates paste is irritating to the eyes.

Executive summary:

Six rabbits were divided into two treatment groups: 0.1 mL of a 50% w/w solution of the test material B0010 (44% KAS paste) in distilled water was instilled into one eye each of three rabbits (Group I); a second group of three rabbits received the same treatment as Group I, followed at 4 sec by a 20 mL lukewarm tap water rinse (Group II). The eyes were examined for corneal opacity, iritis and conjunctivitis at 1 h and on Days 1, 2, 3, 4, 7, 14, 21 and 28 following treatment and were graded using Draize ocular irritation grading system.

All three eyes in Group I were assigned positive scores for corneal opacity and ulceration, iritis, conjunctival redness and chemosis. Two eyes were clear on Day 28 of the study and showed signs of eye irritation on Day 21 of the study.

Three eyes in Group II were assigned positive scores for corneal opacity. Three eyes were observed to have positive scores for conjunctival redness and two for chemosis. In addition, two eyes were assigned positive score for iritis. One eye was clear on Day 3 and two on Day 21 of the study.