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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 1985-06-18
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

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, 4791 Borchen, Germany
- Age at study initiation: male: 7 - 10 weeks; female: 5 - 8 weeks
- Weight at study initiation: male: 310 - 468 g; female: 310 - 416 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/ occlusive
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)
Positive control substance(s):
no

Results and discussion

Positive control results:
no positive control

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1 %
No. with + reactions:
14
Total no. in group:
20
Clinical observations:
Erythema; Edema
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1 %
No. with + reactions:
14
Total no. in group:
20
Clinical observations:
Erythema; Edema
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1 %
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
Erythema; Edema
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1 %
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Erythema; Edema
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 the study, diammonium persulfate was sensitizing when applied to guinea pigs. Thus, diammonium persulfate was classified as skin sensitiser.
Executive summary:

Diammonium persulfate was tested for skin sensitising properties in Guinea pigs according to OECD guideline 406. After challenge, erythema and oedema were observed in 16 of 20 guinea pigs in the test group, compare to only 3 control animals that revealed slight erythema. All animals remained healthy and gained weight during the study. Under the conditions of this study, the test material diammonium persulfate was considered sensitizing.