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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:
1983-03-08 to 1983-03-29
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
GLP compliance:
no

Test material

Constituent 1
Test material form:
solid: crystalline

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation: 4 - 5 months
- Weight at study initiation: 2.0 - 2.1 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): standardised test animal feed, Altromin
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1°C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
A total volume of 0.1 mL of the test item was used for the study in pure state, in a single dose
Duration of treatment / exposure:
NA
Observation period (in vivo):
The eyes were examined at 1 hour, 24, 48 and 72 hours after the treatment. The duration of the observation period was sufficient for the statement of reversibility or irreversibility of changes.
All of the observations were performed using a hand slit lamp.
Number of animals or in vitro replicates:
3 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The determined irritating index was 10.5.
Other effects:
No other effects.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the study and the study criteria, diammonium persulfate was not considered eye irritating.
Executive summary:

Diammonium persulfate was tested for eye irritation properties in rabbits according to OECD guideline 405. 0.1 mL of the test item was placed into the conjunctival sac of one eye of the animals. The untreated eye served as control. One hour after application cornea irritation and diffuse areas of opacity was observed in one of the three animals. Conjunctival redness, obvious swelling with partial eversion of lids plus hypersecretion were observed (in one animal, one hour after application. 72 hours after application full recovery was observed. The determined irritating index was 10.5. Under the conditions of this study diammonium persulfate was considered to be slightly irritating to eyes. No systemic-toxic effects were observed and the general state of the animals was good throughout the study period.