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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999-10-14 to 1999-10-23
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts
EC Number:
274-263-7
EC Name:
Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts
Cas Number:
70024-69-0
Molecular formula:
Cannot be adequately determined for this UVCB substance
IUPAC Name:
Petroleum, mono-C16-24 linear saturated alkaryl derivatised benzenesulphonic acid calcium salts
Test material form:
other: liquid
Details on test material:
- Storage condition of test material: Ambient
- Other: clear, dark brown viscous liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products
- Age at study initiation: Young adult
- Weight at study initiation: 2141 to 2331 g
- Housing: Individual suspended wire mesh cages
- Diet (e.g. ad libitum): Certified Rabbit Lab diet 150 g/day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C
- Humidity (%): 30.2 - 48.5%
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:
Eyelids of animals were held closed for one second after installation.
Observation period (in vivo):
1, 24, 48 and 72 hours following dosing and on day 4.
Number of animals or in vitro replicates:
3 male / 3 female
Details on study design:
REMOVAL OF TEST SUBSTANCE: Washing (if done): unwashed exposure
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: ophthalmoscope/ fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
mean
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Remarks:
mean
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Remarks:
mean
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Remarks:
mean
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Remarks:
mean
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Remarks:
mean
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Remarks:
mean
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Remarks:
mean
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Remarks:
mean
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Remarks:
mean
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Remarks:
mean
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Remarks:
mean
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
mean
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Remarks:
mean
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
mean
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
mean
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Remarks:
mean
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
mean
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Remarks:
mean
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Remarks:
mean
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Remarks:
mean
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Remarks:
mean
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Remarks:
mean
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Remarks:
mean
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 4 days
Other effects:
One animal had clear discharge from the eye, one hour post dosing. There were no deaths or changes in bodyweight throughout the study.

Applicant's summary and conclusion

Interpretation of results:
other: EU-GHS criteria not met
Conclusions:
Mean scores at 24, 48 and 72 hours for each animal for corneal opacity and iritis was 0 for all animals. Mean scores for conjuntival redness and oedema were less than 2 in all animals. Therefore, the calcium sulfonate test substance (CAS 70024-69-0) is not irritating to rabbit eyes.
Executive summary:

In the key study, the eye irritation potential of the calcium sulfonate test substance, (CAS 70024 -69 -0), was evaluated in accordance with EPA OPPTS 870.2400 (Kern, 1999e). A group of six albino rabbits (3 per sex) was used for the study. Each animal received a single, unwashed exposure of 0.1 mL of the test article instilled into the lower conjunctival sac of the right eye. The eyelid was held closed for approximately one second and released. The left eye was manipulated in a similar manner as the right eye and served as a contralateral control. Observations for eye irritation were made at 1, 24, 48 and 72 hours following dosing and on day 4 in accordance with the method of Draize. One animal had clear discharge from the eye, one hour post dosing. There were no deaths or changes in bodyweight throughout the study. Mean 24, 48, and 72 hour corneal and iris scores were 0 for all animals tested. The conjunctival erythema score were 1.3, 1, 1, 1, 1, and 1, respectively and were all reversible within 7 days. The chemosis scores were 0.3, 1.3, 0.3, 0, 0 and 1, respectively. In this study, the calcium sulfonate test substance is not an eye irritant.