Registration Dossier
Registration Dossier
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EC number: 258-799-9 | CAS number: 53817-09-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976-04-28 to 1977-06-07
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically acceptable study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: BASF-internal standard
- GLP compliance:
- no
Test material
- Reference substance name:
- 4-amino-N-(2-ethylhexyl)benzenesulphonamide
- EC Number:
- 258-799-9
- EC Name:
- 4-amino-N-(2-ethylhexyl)benzenesulphonamide
- Cas Number:
- 53817-09-7
- Molecular formula:
- C14H24N2O2S
- IUPAC Name:
- 4-amino-N-(2-ethylhexyl)benzene-1-sulfonamide
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: animal #1 2.99 kg, animal #2 2.82 kg
- Diet: Ssniff
IN-LIFE DATES: From: 1976-03-24 To: 1976-04-01
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other eye of test animal treated was with talcum powder
- Amount / concentration applied:
- about 50 mm3, i.e. ca. 50 mg
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was not washed out
SCORING SYSTEM: observed were the parameters redness and chemosis of conjunctivae, and corneal opacity
Grading system for redness and edema: The data reported have to be converted into presently used numerical grading system as given in the following table
"reizlos" (no symptom) Ø, "fraglich" (questionable) (+): considered as equivalent to grade 0 (no irritating effect) according to OECD Draize scheme
"leicht" (slight) +: considered as equivalent to grade 1 (very slight effect) according to OECD Draize scheme
"stark" (marked) ++: considered as equivalent to grade 2 (well-defined effect) effect according to OECD Draize scheme
"sehr stark" (severe) +++: considered as equivalent to grade ≥3 (severe effect) according to OECD Draize scheme
Grading system for iritis: iritis + or ++ equals Draize scheme grade 1 or 2, respectively.
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: in addition a "smeary layer" was reported at 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- Test item treatment: Slight conjunctival redness was observed at both test animals after 1 h and after 24 h; effects observed to be fully reversible after 8 d.
Control eye treatment with talcum: Control eye of both animals showed slight conjunctival redness after 1 h and after 24 h such as the eye treated with test item; effects also observed to be fully reversible after 8 d. Both control eyes furthermore showed edema after 1 h, grade 3 for animal #1 and grade 2 for animal #2.
Any other information on results incl. tables
Table of results based on grading system as applied in the study report
time |
animal 1 |
animal 2 |
|
conjunctivae |
1 h |
+ |
+ |
24 h |
+ |
+ |
|
8 d |
Ø |
Ø |
|
chemosis |
1 h |
Ø |
Ø |
24 h |
Ø |
Ø |
|
8 d |
Ø |
Ø |
|
cornea |
1 h |
Ø |
Ø |
24 h |
Ø |
Ø |
|
8 d |
Ø |
Ø |
Table of results based on grading system as applied by the Draize scheme
time |
animal 1 |
animal 2 |
|
conjunctivae |
1 h |
1 |
1 |
24 h |
1 |
1 |
|
8 d |
0 |
0 |
|
chemosis |
1 h |
0 |
0 |
24 h |
0 |
0 |
|
8 d |
0 |
0 |
|
cornea |
1 h |
0 |
0 |
24 h |
0 |
0 |
|
8 d |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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