Registration Dossier
Registration Dossier
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EC number: 258-799-9 | CAS number: 53817-09-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: animal #1 3.07 kg, animal #2 3.22 kg
- Diet: Ssniff
IN-LIFE DATES: From: 1976-03-24 To: 1976-05-06
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: untreated skin of the animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): about 1 g
- Concentration (if solution): 50% aqueous test substance preparation - Duration of treatment / exposure:
- 20 h
- Observation period:
- 8 d
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: ear 2,5 cm x 2.5 cm; back area not specified, according to study report "application by a cotton ball"
- Type of wrap if used: ear: cotton lobes; back: cotton ball
REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was washed off
- Time after start of exposure: after 20 h
SCORING SYSTEM:
Observed effects: observed were the parameters erythema, edema, scaling, and necrosis
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
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: application to back
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: application to back
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: application to back
- Irritant / corrosive response data:
- Application to back for 20 h resulted in grade 1 erythema after 24 h for one of the two test animals, effects observed to be fully reversible on day 8 (other animal without effect).
Application to ear without observed effects at any point in time.
Any other information on results incl. tables
Table of results (20 h application to back) based on grading system as applied in the study report
time |
animal 1 |
animal 2 |
|
erythema |
24 h |
+ |
(+) |
8 d |
Ø |
Ø |
|
edema |
24 h |
Ø |
Ø |
8 d |
Ø |
Ø |
|
scaling |
24 h |
Ø |
Ø |
8 d |
Ø |
Ø |
Table of results (20 h application to back) translated into the grading system as applied by the Draize scheme
time |
animal 1 |
animal 2 |
|
erythema |
24 h |
1 |
0 |
8 d |
0 |
0 |
|
edema |
24 h |
0 |
0 |
8 d |
0 |
0 |
|
scaling |
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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