Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substance Act (FHSA)
Version / remarks:
Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics Assoc, Food and Drug Officials of the US, 2nd printing, Topeka, Kansas, 1965. In accordance with Section 1500.42 Chapter 2, Title 16 Code of Federal Regulations under the Federal Hazardous Substances Act
Principles of method if other than guideline:
Test material instilled undiluted into the conjunctival sac of six rabbits. The eyes of some treated animals were not washed following exposure and other animals had their eyes washed after 20 seconds of exposure. Exposure was followed by 14 days of observation and the grade of occular reaction, based on the scoring scale of Lehman et al 1965 (US FDA), recorded at prescribed intervals. A maximum average score for washed and unwashed eyes was calculated.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonium (xylenes and 4-ethylbenzene) sulphonate
EC Number:
943-024-5
Molecular formula:
C8H13NO3S
IUPAC Name:
Ammonium (xylenes and 4-ethylbenzene) sulphonate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: SLK, Per-DOT, Issac's
- Age at study initiation: young adult
- Weight at study initiation: no data
- Housing: individually in metal cages elevated above the droppings
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):no data

IN-LIFE DATES: From:April 23, 1979 To: May 7, 1979

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 in one eye of each animal (the other eye was not treated and served as a control)
- Concentration (if solution): undiluted

VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle
Duration of treatment / exposure:
6 of the 9 animals were treated and their eyes were not washed. The remaining 3 animals had their eyes washed for one minute following 20 seconds of exposure.
Observation period (in vivo):
All animals (both eyes) at 1, 24, 48, 72 and 96 hours; and at 7, 10 and 14 days
Number of animals or in vitro replicates:
9 total; six with eyes not washed and 3 with eyes washed
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 3 of 9 animals. One minute washing.
- Time after start of exposure: 20 seconds
- All animals were immobilized in a suitable restrainer rack for one hour following treatment

SCORING SYSTEM: scale for scoring as outlined by Lehman, A.J. et al. in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association of Food and Drug Officials of the United States, 1965.TOOL USED TO ASSESS SCORE: fluorescein sodium 2% on the cornea

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.66
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks:
7 days
Irritant / corrosive response data:
Rabbits with treated eyes that were not washed produced within 24 hours conjunctival lesions in the form of a moderate erythema of the palpebral and bulbar conjunctivae, a slight to moderate chemosis of the lids, a slight to moderate watery-mucoid discharge and a slight corneal opacity (4 of the 6 animals) involving one-fourth of less of the corneal surface. The test eyes showed steady improvement with the cornea of all test eyes being reaction free at 72 hours. A maximum average score of 13.7 was recorded at 24 hours.The rabbits with washed eyes following treatment produced within 24 hours conjunctival lesions in the form of a slight erythema of the palpebral and bulbar conjunctivae, a moderate chemosis of the lids, a slight watery-mucoid discharge and a slight corneal opacity involving one-fourth to one-half of the corneal surface. Little change was noted at 48 hours and some deduction of the reaction was noted at 72 hours. The corneal reaction was not present at 96 hours and all test eyes were reaction free by 10 days. A maximum average score of 17.3 was recorded at 48 hours.
Other effects:
None reported

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Irritant
Executive summary:

The eye irritation of Ammonium (xylenes and 4-ethylbenzene) sulfonates was assessed following official guideline Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics Assoc, in accordance with Section 1500.42 Chapter 2, Title 16 Code of Federal Regulations under the Federal Hazardous Substances Act. The results showed effects on eye. Rabbits with treated eyes that were not washed produced within 24 hours conjunctival lesions in the form of a moderate erythema of the palpebral and bulbar conjunctivae, a slight to moderate chemosis of the lids, a slight to moderate watery-mucoid discharge and a slight corneal opacity (4 of the 6 animals) involving one-fourth of less of the corneal surface. The test eyes showed steady improvement with the cornea of all test eyes being reaction free at 72 hours. A maximum average score of 13.7 was recorded at 24 hours. The rabbits with washed eyes following treatment produced within 24 hours conjunctival lesions in the form of a slight erythema of the palpebral and bulbar conjunctivae, a moderate chemosis of the lids, a slight watery-mucoid discharge and a slight corneal opacity involving one-fourth to one-half of the corneal surface. Little change was noted at 48 hours and some deduction of the reaction was noted at 72 hours. The corneal reaction was not present at 96 hours and all test eyes were reaction free by 10 days.  A maximum average score of 17.3 was recorded at 48 hours.