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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.