Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye 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 405. 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 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: 92/69/EWWG.
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 / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye serves as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg.
Duration of treatment / exposure:
Single application.
Observation period (in vivo):
22 days.
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Scoring system according to OECD 405 and EU method B.5.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h.
Score:
2.3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h.
Score:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h.
Score:
2.7
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
other: overall at 24, 48 and 72 h.
Score:
2.67
Max. score:
3
Reversibility:
other: Max duration: h; Max value at the end of observation period: 2 (related to all animals).
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h.
Score:
1.7
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h.
Score:
3
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h.
Score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: overall at 24, 48 and 72 h.
Score:
0.9
Max. score:
3
Reversibility:
other: Max duration: h; Max value at the end of observation period: 3 (related to all animals).
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h.
Score:
0.7
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h.
Score:
1.3
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h.
Score:
2
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: overall at 24, 48 and 72h.
Score:
1.33
Max. score:
2
Reversibility:
other: Max duration: h; Max value at the end of observation period: 1 (related to all animals).
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h.
Score:
0.7
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h.
Score:
1
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h.
Score:
1
Irritation parameter:
iris score
Basis:
mean
Time point:
other: overall at 24, 48 and 72 h.
Score:
0.9
Max. score:
1
Reversibility:
other: Max duration: h; Max value at the end of observation period: 1 (related to all animals).
Irritant / corrosive response data:
Reversibility of any observed effect: Changes were not fully reversible within 22 days.
Other effects:
Brownish or whitish areas on the conjunctivae were noted in all the animals. Neovascularisation and alopecia around the eye, continuing at the end of the observation period, were observed in 1/3 animals.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance resulted irritating to the eye of the rabbits. Changes were not fully reversible within 22 days.
Executive summary:

A study for eye irritation/ corrosion was performed according to OECD 405, EU method B.5 and 92/69/EWG. Three white New Zealand rabbits were instilled 100 mg of the test substance into one eye, the untreated served as control. The following irritation parameters were recorded at 24, 48 and 72 according to OECD 404 scoring system: Conjunctivae score (redness), chemosis score, cornea score and iris score. Adverse effects were seen for all irritation parameters. Changes were not fully reversible within 22 days. The substance can be classified as ocular irritant.