Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Principles of method if other than guideline:
BASF-Test
GLP compliance:
no
Remarks:
pre-GLP study

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonium sulphate
EC Number:
231-984-1
EC Name:
Ammonium sulphate
Cas Number:
7783-20-2
Molecular formula:
H3N.1/2H2O4S
IUPAC Name:
Monochloramine generated from ammonium sulphate and a chlorine source
Test material form:
solid: crystalline

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: talkum was placed into the other eye of the test animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied 50 µl bulk volume
Duration of treatment / exposure:
instillation without rinsing
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE: no

SCORING SYSTEM:
BASF scoring system, convertible to Draize score system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 , 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
Slight edema and conjunctival redness was noted at 1 hour after instillation of the test substance; no edema, but still slight redness was present at 24 hours. In the eyes treated with talcum, slight redness was also noted at 1 and 24 hours after exposure. No effects were noted at day 8.

Any other information on results incl. tables

Table: Draize scores

Reading

Test substance

unchanged

Talkum

(control)

Erythema

Edema

Erythema

Edema

1 h

1

1

1

0

24 h

1

0

1

0

8 d

No findings

No findings

Applicant's summary and conclusion