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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-methanesulfonyl-2-nitrobenzoic acid
EC Number:
601-017-1
Cas Number:
110964-79-9
Molecular formula:
C8 H7 N1 O6 S1
IUPAC Name:
4-methanesulfonyl-2-nitrobenzoic acid
Details on test material:
- Name of test material (as cited in study report): 2-Nitro-4-methylsulfonyl benzoic acid (MNBA)
- Physical state: Solid
- Analytical purity: 97 % (w/w)
- Lot/batch No.: 15483-30-1
- Storage condition of test material: Ambient temperature in darkness

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: treated: left eye; unterated (control): right eye
Amount / concentration applied:
1OOmg/eye/animal
Duration of treatment / exposure:
treatment without rinsing
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: # 13
Time point:
other: mean of 24, 48, 72 h
Score:
0.3
Reversibility:
fully reversible within: 2 d
Irritation parameter:
cornea opacity score
Basis:
animal: # 7
Time point:
other: mean of 24, 48, 72 h
Score:
0.7
Reversibility:
fully reversible within: 3 d
Irritation parameter:
cornea opacity score
Basis:
animal: # 8, 9, 10 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Reversibility:
other: no signs of irritation (cornea) at any time
Irritation parameter:
cornea opacity score
Basis:
animal: # 11
Time point:
other: mean of 24, 48, 72 h
Score:
0.7
Reversibility:
fully reversible within: 3 d
Irritation parameter:
iris score
Basis:
animal: # 13, 7, 8, 11 each
Time point:
other: mean of 24, 48, 72 h
Score:
0.7
Reversibility:
fully reversible within: 3 d
Irritation parameter:
iris score
Basis:
animal: # 9
Time point:
other: mean of 24, 48, 72 h
Score:
0.3
Reversibility:
fully reversible within: 2 d
Irritation parameter:
iris score
Basis:
animal: # 10
Time point:
other: mean of 24, 48, 72 h
Score:
1
Reversibility:
fully reversible within: 4
Irritation parameter:
conjunctivae score
Basis:
animal: # 13, 8, 9, 10 each
Time point:
other: mean of 24, 48, 72 h
Score:
2
Reversibility:
fully reversible within: 14 - 21 d
Irritation parameter:
conjunctivae score
Basis:
animal: # 7
Time point:
other: mean of 24, 48, 72 h
Score:
3
Reversibility:
fully reversible within: 11 d
Irritation parameter:
conjunctivae score
Basis:
animal: # 11
Time point:
other: mean of 24, 48, 72 h
Score:
2.7
Reversibility:
fully reversible within: 21 d
Irritation parameter:
chemosis score
Basis:
animal: # 13 and 11 each
Time point:
other: mean of 24, 48, 72 h
Score:
2.3
Reversibility:
fully reversible within: 10 - 14 d
Irritation parameter:
chemosis score
Basis:
animal: # 7, 9, 10 each
Time point:
other: mean of 24, 48, 72 h
Score:
2
Reversibility:
fully reversible within: 7 - 11 d
Irritation parameter:
chemosis score
Basis:
animal: # 8
Time point:
other: mean of 24, 48, 72 h
Score:
1.7
Reversibility:
fully reversible within: 4 d
Irritant / corrosive response data:
Additional signs of irritation included erythematous, thickened and convoluted eyelids, mucoid discharge and haemorrhage of the nictitating membrane. Some animals held their dosed eye closed which may be indicative of pain.

All signs of irritation were fully reversible within 21 days.
Other effects:
No other effects were reported.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
MNBA was irritant to the rabbit eye.
Executive summary:

2-Nitro-4-methylsulfonyl benzoic acid (MNBA) was applied into one eye of each of six rabbits and an assessment of initial pain was made. The eyes were examined for up to 21 days, to assess the grade of ocular reaction.

Application into the eye caused slight initial pain.

Slight corneal opacity and iritis were observed, and had completely regressed 4 days after application. Conjunctival effects, consisting of slight to severe redness, chemosis and discharge in all animals, had completely regressed 21 days after application.

MNBA was irritant to the rabbit eye.