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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:
other: meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Principles of method if other than guideline:
About 50 mg of the unchanged (solid) test substance were applied into the right eyes of two rabbits. The left eyes of both rabbits were treated with
talcum and served as control. Readings were performed 1 and 24 h as well as 8 d after treatment.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Naphthalene-2-sulphonic acid
EC Number:
204-375-3
EC Name:
Naphthalene-2-sulphonic acid
Cas Number:
120-18-3
Molecular formula:
C10 H8 O3 S
IUPAC Name:
naphthalene-2-sulfonic acid
Details on test material:
- Name of test material (as cited in study report): beta-Naphthalinsulfonsäure
- Physical state: solid, amorph
- Analytical purity: technical grade (no further data)

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: male: 3,96 kg; female: 3,01 kg
no further data


ENVIRONMENTAL CONDITIONS
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
EST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg
Duration of treatment / exposure:
single application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
not removed


SCORING SYSTEM: Descriptive scores of the raw data were converted into OECD/Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 -72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Necrosis of the margins of the eye lids and suppuration was observed at the end of the study, in addition marked corneal opacity was observed during the study; see table for details
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 -72 h
Score:
0
Max. score:
2
Reversibility:
other: not observed/not observable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 -72 h
Score:
0
Max. score:
3
Reversibility:
other: not observed/not observable
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 -72 h
Score:
3
Max. score:
4
Reversibility:
other: not observable

Any other information on results incl. tables

Animal  Reading  Opacity Iritis Redness Chemosis Comment
1 1 h 4 0 0 3 cauterized, purulence, eye half-closed
2 1 h 4 0 0 0 cauterized, eyelid borders red
1 3 h 4 0 0 2 cauterized, bulbus thick and white, eyelid borders red
2 3 h 4 0 0 0 cauterized, eyelid borders red
1 24 h 4 0 0 3 cauterized, some bleeding, edema also in the area around the eye, secretion
2 24 h 4 0 0 3 cauterized, eyelid borders somewhat red, secretion
1 48 h 4 0 0 3 cauterized, eye glotted with purulence, bleeding, eyelid borders red
2 48 h 4 0 0 3 cauterized, eye glotted with purulence, eyelid borders crusty
1 72 h 4 0 0 3 cauterized, staphyloma formation, purulence, bleeding, surrounding bloody crusted
2 72 h 4 0 0 3 cauterized, purulence, eyelid borders red
1 6 d       4 eye almost closed, strong purulence, lower lid hard necrotic
2 6 d         eye almost closed, bleeding, purulence, eyelid crusty
1 8 d         eye closed, purulence, lower lid hard necrotic, bulbus not assessable
2 8 d         eye closed, purulence, lower lid hard necrotic, bulbus not assessable
1 24 - 72 h 4.00 0.00 0.00 3.00  
2 24 - 72 h 4.00 0.00 0.00 3.00  
mean 24 - 72 h 4.00 0.00 0.00 3.00  

Empty fields are considered as not assessable due to corrosive findings described in the corresponding comment fields.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
risk of serious damage to eyes

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