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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1983-03-02 to 1983-03-16; Addendum: 1983-06-07
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study.
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 404 (Acute Dermal Irritation / Corrosion)
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: solid, white
- Analytical purity: > 99%

Test animals

Species:
rabbit
Strain:
other: Albino - White Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation: 4-5 months
- Weight at study initiation: 2.0 - 2.2 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 (%): 50 - 60 %
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
0.5 g of test substance.
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 h
Number of animals:
3
Details on study design:
The test was applied on the scarified rabbit skin.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 2 weeks
Remarks on result:
other: test was performed on scarified skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.89
Max. score:
4
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: test was performed on scarified skin
Irritant / corrosive response data:
The result of local irritation testing on the scarified rabbit skin after single application showed corrosion to the skin. This result was upraised due to the severe and prolonged changes on the scarified dermis after contact with the test substance.

Any other information on results incl. tables

Erythema was present one hour after removal of the occlusive bandage from the scarified epidermis and was evaluated with the rating 3 and 4 (moderate and severe erythema, eschar formation with profound damage). The irritations persisted with same intensity over the 14 day observation period. The first day after application of the test material, eschar formation occurred, and loss of substance became visible at the location of application, which showed circular cavities with a depth of 1 to 2 mm. The eschar sloughed during the second observation week. The reparation process started with scar formation without reaching the level of the health skin area completely.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Under the conditions of the study diammonium persulfate caused severe erythema which was not fully reversible within the 14 days. Thus, the test item was considered irritating to the skin.
Executive summary:

Diammonium persulfate was tested for skin irritation on three rabbits. Diammonium persulfate showed formation of severe non-reversible erythema and slight oedema. Based on these results diammonium persulfate was considered irritating to the skin.