Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
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-reference
Reason / purpose:
reference to same study
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1983-03-02 to 1983-03-16
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Non-GLP study.
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
other: Albino - White Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- 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 ± 1°C
- Humidity (%): 50 - 60 %
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
0.5 g of the test substance
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
No systemic-toxic effects occurred after treatment with the test material. All animals remained healthy throughout the study.
Interpretation of results:
GHS criteria not met
Conclusions:
Under conditions of the study, diammonium persulfate revealed no skin irritating properties.
Executive summary:

Diammonium persulfate was applied in a single dose of 0.5 g diammonium persulfate to intact skin of albino rabbits. One hour after the end of the exposure period the three rabbits had slight erythema which disappeared at the time of the study observation time points after 24 and 48 hours. None of the animals reach an average of erythema or oedema score of equal or above 2. The highest score (oedema score) was 0.33 obtained in one of the three rabbits. Under the conditions of the study diammonium persulfate was not considered irritating to skin. Additionally no systemic-toxic effects occur after treatment with the test material. All animals remained healthy throughout the 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
Test material form:
solid: crystalline

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:
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:
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
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.