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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
data is from experimental reports

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
other: Federal Register Vol 50 no 188, Part II, 27 September 1985
Version / remarks:
section 798-4100- dermal sensitisation
Principles of method if other than guideline:
A study as performed in guinea pigs to determine the sensitization potential of the test chemical
GLP compliance:
yes
Remarks:
QA statement and statement by study director in the report
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
LLNA test not available at the time of testing. GPMT test considered to be adequate data

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material: 3-Pyrazolidinone, 4-methyl-1-phenyl-
- Molecular formula: C10H12N2O
- Molecular weight: 176.219 g/mole
- Smiles: O=C1NN(c2ccccc2)CC1C
- Inchl: InChI=1/C10H12N2O/c1-8-7-12(11-10(8)13)9-5-3-2-4-6-9/h2- 6,8H,7H2,1H3,(H,11,13)/f/h11H
- Substance type: Organic
- Physical state: solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: D. Hall New Church Staffordshire England
- Females (if applicable) nulliparous and non-pregnant; not specified
- Age at study initiation: no data
- Weight at study initiation: 385-488 g
- Housing: cages with wire mesh floors
- Diet: Vitamin C enriched Guinea-Pig Diet F.D.I.. ad libitum
- Water; tap water ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C):ca 21 °C
- Humidity (%): 30-70%
- Air changes (per hr): ca 15/hr
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
coconut oil
Remarks:
Alembicol D
Concentration / amount:
5%
Day(s)/duration:
NA
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
coconut oil
Remarks:
Alembicol D
Concentration / amount:
50%
Day(s)/duration:
48 hours
Adequacy of induction:
highest technically applicable concentration used
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
coconut oil
Remarks:
Alembicol D
Concentration / amount:
10 and 20%
Day(s)/duration:
24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20 treatment and 20 control
Details on study design:
RANGE FINDING TESTS: PIT was performed but not reported in the study report. Concentrations were chosen based on the outcome of this test

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Exposure period: 48 hours epicutaneous
- Test groups: 20 females
- Control group: 20 females (vehicle)
- Site: scapular region
- Concentrations: 5% intradermal, 50% epicutaneous
intradermal :according to the guideline
epucutaneous: one week after intradermal challenge

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after induction
- Exposure period: 24 hours
- Test groups: 20 females
- Control group: 20 females
- Site: 2 patches were applied to the flank saturated with 10% or 20% substance in the vehicle
- Evaluation (hr after challenge): 24, 48 and 72 hours

Challenge controls:
yes
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10%
No. with + reactions:
14
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: slight erythema
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
20%
No. with + reactions:
18
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: very slight erythema and incidental oedema
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10 and 20%
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: slight erythema at 20%
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10%
No. with + reactions:
15
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: slight erythema and oedema
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
20%
No. with + reactions:
16
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: well defined etythema and oedema
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 and 20%
No. with + reactions:
4
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: slight erythema in 0 animals at 10% and 4 animals at 20%
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test group
Dose level:
10%
No. with + reactions:
4
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: well defined erythema, in an additional 12 animals slight effects were seen
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test group
Dose level:
20%
No. with + reactions:
14
Total no. in group:
20
Clinical observations:
none
Remarks on result:
positive indication of skin sensitisation
Remarks:
well defines erythema and slight oedema
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
10 and 20%
No. with + reactions:
4
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: very slight eryhema in 0 amimals at 10% and in 4 animals at 20%

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
A positive result was reported in 14 of the test substance induced females. This result was indicative for sensitizing properties of the substance.
Hence, the test chemical can be considered to be sensitizing to skin.
Executive summary:

In a GPMT test performed according to the method of Magnussen -Kligman, 20 female Dunkin- Hartley guinea-pigs were induced intradermally and epicutaneously with 5 and 50% of the substance respectively. 20 control females received the same treatment with the vehicle (coconut oil). After 2 weeks an epicutaneous challenge was initiated at 10 and 20% of the substance in vehicle. Flanks were assessed for erythema and oedema at 24, 48 and 72 hours after challenge.

A positive result was reported in 14 of the test substance induced females. This result is indicative for sensitizing properties of the substance. Hence, the test chemical can be considered to be sensitizing to skin.