Registration Dossier
Registration Dossier
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EC number: 204-375-3 | CAS number: 120-18-3
Eye irritation
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:
- 1 972
- 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
- 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)
Constituent 1
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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