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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983-02-14 to 1983-04-08
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
(1981)
Deviations:
no
GLP compliance:
no
Type of study:
Freund's complete adjuvant test
Justification for non-LLNA method:
Study was performed before LLNA-method was described as OECD test guideline and before it could be established in the EU-REACH regulation.

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): disodium peroxodisulfate
- Physical state: crystalline, white powder
- Analytical purity: > 99%
- Storage condition of test material: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, D-4791 Borchen
- Age at study initiation: male: 5 - 10 weeks; female: 6 - 7 weeks
- Weight at study initiation: male: 314 - 485 g; female: 330 - 387 g
- Housing: individually in cages
- Diet (e.g. ad libitum): standardised test animal feed, Altromin; ad libitum
- Water (e.g. ad libitum): tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 60 ± 10 %
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.1 %
Challenge
Route:
other: intradermal and epidermal
Vehicle:
physiological saline
Concentration / amount:
0.1 %
No. of animals per dose:
20 (test group)
20 (control group)
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: -
- Test groups: test substance (TS) in FCA
- Control group: only FCA
- Site: right flank, back, neck
- Frequency of applications: day 1., 3., 5. (test material)
day 8., 12., 15., 17., 19. (test material plus Freunds complete adjuvant)
- Duration: 0 - 19 d
- Concentrations: 0.1 % , same throughout

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 36. and 50
- Exposure period: -
- Test groups: TS
- Control group: TS
- Site: right flank, back
- Concentrations: 0.1 % and 1 %
- Evaluation (hr after challenge): day 37 (24 hours after application); day 52 and 53 (24 and 48 hours after patch removal)
Challenge controls:
control group: 20 animals (10 male, 10 female)
application: 0.1 ml of 0.1% test-solution
Positive control substance(s):
no

Results and discussion

Positive control results:
no positive control

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1 %
No. with + reactions:
9
Total no. in group:
19
Clinical observations:
Erythema; Oedema
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1 %
No. with + reactions:
11
Total no. in group:
19
Clinical observations:
Erythema; Oedema
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1 %
No. with + reactions:
3
Total no. in group:
19
Clinical observations:
Erythema, Oedema
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1 %
No. with + reactions:
1
Total no. in group:
19
Clinical observations:
Erythema; Oedema
Key result
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Under the conditions of this study, the test material disodium persulfate was sensitizing when applied to Pirbright White guinea pigs.
Disodium persulfate was classified as skin sensitiser cat. 1 H317 (may cause an allergic skin reaction) according to Regulation 1271/2008/EC (CLP)
Executive summary:

Disodium persulfate was tested for skin sensitization properties in Guinea pigs according to OECD Guideline 406. At the second reading after (topical) challenge erythema and sporadical oedema were observed at 11 test animals compared to only 1 control animal who revealed slight erythema and oedema. Under the conditions of this study, the test material disodium persulfate was considered sensitizing when applied to guinea pigs. No systemic-toxic effects were verifiable.