Naphthalenesulfonic acid, di-C9-rich C8-10-branched alkyl derivs., barium salts

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was initiated on January 19, 1995. The experimental start date was February 7,1995 and the experimental termination date was February 17, 1995.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study followed guidelines with minor deviations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4500 (Acute Eye Irritation)

Deviations:

yes

Remarks:

The stability, identity, strength, purity, and composition or other characteristics which identify the test substance were the responsibility of the sponsor

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

barium bis(di C8-C10, branched, C9 rich, alkylnaphthalenesulphonate)

EC Number:

939-718-2

Cas Number:

1474044-80-8

Molecular formula:

C28H44O3S.1/2Ba

IUPAC Name:

barium bis(di C8-C10, branched, C9 rich, alkylnaphthalenesulphonate)

Test material form:

other: as solution in light paraffinic and naphthenic petroleum distillates

Details on test material:

brown colored homogeneous viscous liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

The animals were individually housed in suspended cages with wire mesh bottoms. The absorbent
paper under the cages was changed daily. The animals were fed a restricted diet (125 glday) of
Purina High Fiber Lab Chow #5326 and received well water .ad libitum. No contaminant was
expected to be present in the feed or water at a level sufficient to interfere with the study. The
animals were transferred to another room on day 2 of the study. The room temperature of the first
room was maintained at 66-69D F with a relative humidity of 34-82%. The room temperature of the
second room was maintained at 66-70D F with a relative humidity of 26-71%.
The females were approximately 20 weeks old at dosing and the males were approximately 18
weeks old The animals were individually identified by an individual ear tag and cage card Body
weights were not recorded. ·

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

Single application without rinsing.

Observation period (in vivo):

Both eyes were grossly examined and the test eye scored by the Draize method at
1, 24, 48, and 72 hours and at 7 and 10 days after instillation of the test material. All eyes were
also examined for the presence of corneal ulcerations at 24 hours using 2% sodium fluorescein.

Number of animals or in vitro replicates:

Three male and three female New Zealand White rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
- Time after start of exposure:
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: All eyes were
also examined for the presence of corneal ulcerations at 24 hours using 2% sodium fluorescein.
Animals with ulcerations were reexamined with 2% fluorescein sodium during subsequent
observations until the ulcerations were no longer apparent. A plastic Elizabethan style collar was
placed on each animal to prevent mechanical irritation of the eye.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0.2

Max. score:

0.7

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0.3

Reversibility:

fully reversible within: 24 hours

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24/48/72 h

Score:

1.5

Max. score:

2.7

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1.7

Max. score:

2.5

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Slight iridial irritation was observed in 2/6 animals and moderate to severe conjunctival irritation in
all animals at 1 hour. Corneal opacities were present in 4/6 animals and corneal ulcerations in 2/6
animals at 24 hours. The corneal opacities and ulcerations were not present at 48 hours. Moderate
to severe conjunctival irritation was still present at 24 hours and diminished quickly over the
remainder of the study.

Any other information on results incl. tables

EC Score:

Obs	1-Hr	24-Hrs	48-Hr	72-Hr	7-Days	10-Days	Mean Days1-3
Corneal Opacity	0.0	0.7	0.0	0.0	0.0	0.0	0.2
Iritis	0.3	0.0	0.0	0.0	0.0	0.0	0.0
ConjunctivalRedness	2.2	2.7	1.2	0.7	0.2	0.0	1.5
ConjunctivalSwelling	2.2	2.5	1.7	1.0	0.2	0.0	1.7

 

EC Calculation: The cumulative means of the scores were calculated for corneal opacity, iritis, and conjunctival redness and swelling at 24, 48, and 72 hours.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

NA-SUL
BSN is not an eye irritant according to EC guidelines because the combined mean scores for the cornea, iris, conjunctival redness, or conjunctival swelling were not greater than or equal to 1.0, 1.0, 2.0, or 2.0, respectively.

Executive summary:

The acute ocular irritation of NA-SUL BSN was evaluated in three male and three female New Zealand White rabbits. A single 0.1 ml aliquot of the test material was instilled into the left conjunctival sac of each animal. The eye was gently held shut for approximately one second. A plastic Elizabethan collar was placed on each animal after dosing to prevent access to the test site. Both eyes were examined and the test eye scored according to the Draize method at 1, 24, 48, and 72 hours and at 7 and 10 days after instillation of the test material. All the test eyes were examined for the presence of corneal ulcerations at 24 hours with 2% sodium fluorescein. Those eyes with ulcerations were restained during each observation period until the ulceration healed. Clinical observations were recorded at approximately 1 and 4 hours after dosing and daily thereafter except on the weekend for the remainder of the study. Body weights were not recorded. All animals were sacrificed by over-exposure to carbon dioxide on day 10. Slight iridial irritation was observed in 2/6 animals and moderate to severe conjunctival irritation in all animals at 1 hour. Corneal opacities were present in 4/6 animals and corneal ulcerations in 2/6 animals at 24 hours. The corneal opacities and ulcerations were no longer present at 48 hours. Moderate to severe conjunctival irritation was still present at 24 hours and diminished quickly over the remainder of the study. The 24-hour mean Draize score was 18.9/110. The mean EC (24-, 48-, and 72-hour) ocular irritation scores were 0.2 for corneal opacity, 0.0 for iritis; 1.5 for conjunctival redness; and 1.7 for conjunctival swelling. Soft stool was noted in all animals on day 1, in 3/6 animals on day 2, and in 1/6 animals on day 3. Decreased food consumption was observed in 216 animals on day 1. Decreased fecal output was noted in all animals on day 6. No other clinical observations were noted. BSN is not an eye irritant according to EC guidelines because the combined mean scores for the cornea, iris, conjunctival redness, or conjunctival swelling were not greater than or equal to 1.0, 1.0, 2.0, or 2.0, respectively.