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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1983-03-08 to 1983-03-29
Reliability:
1 (reliable without restriction)
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Principles of method if other than guideline:
NA
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): diammonium persulfate
- Physical state: crystalline, white powder
- Analytical purity: > 99%

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 °C ± 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
Details on study design:
NA

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: no
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: no
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: no
Irritation parameter:
conjunctivae score
Remarks:
(chemosis)
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: no
Irritant / corrosive response data:
The determined irritating index was 10.5.
Other effects:
No other effects.

Any other information on results incl. tables

No remarks

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Interpretation of the study author according to a testing scale (see above in "any other information on materials and methods).
Conclusions:
Under the conditions of the study and the study criteria, diammonium persulfate was considered slightly 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.