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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test method according to OECD 404. GLP study.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
479-480-2
EC Name:
-
Cas Number:
17852-52-7
Molecular formula:
C6H9N3O2S.ClH
IUPAC Name:
4-hydrazinylbenzene-1-sulfonamide hydrochloride
Test material form:
not specified
Details on test material:
- Name of test material: 4-hydrazinylbenzenesulfonamide hydrochloride.

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 500 mg.
Duration of treatment / exposure:
4 hours.
Observation period:
72 hours.
Number of animals:
3
Details on study design:
SCORING SYSTEM: Scoring system according to OECD guideline 404, EU method B.4.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h.
Score:
1
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: overall at 24, 48 and 72 h.
Score:
0.33
Max. score:
1
Reversibility:
other: Max. duration: 5 d.; Max value at end of observation period : 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: overall at 24, 48 and 72 h.
Score:
0
Max. score:
0
Reversibility:
other: Max. duration: 0 d.; Max value at end of observation period : 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of a y observed effect: Changes fully reversible within 6 days.
Other effects:
After 4 hours' exposure to light (three animals), a yellowish discoloration of the treated are of skin was observed in 1/2 of the animals on day 3 and 4.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance showed no potential of skin irritation/corrosion.
Executive summary:

A skin irritation/ corrosion test was performed according to OECD guideline 404, EU method B.4. and 92/69/EWG. Three New Zealand white rabbits were exposed in semiocclusive conditions to 500 mg of the test substance for 4 hours. A yellowish discoloration of the treated area of skin was observed in 1/3 animals on days 3 and 4. Changes were fully reversible within 6 days.