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Diss Factsheets

Administrative data

Description of key information

Fenpropimorph did not show skin sensitizing properties in a GLP conform guinea pig maximization test according to OECD guideline 406.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11.2010 - 05.2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
July 17, 1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
certified by Behörde für Soziales, Familie, Gesundheit und Verbraucherschutz, Hamburg
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
According to OECD guideline 429, the LLNA test is not suitable for the test substance since false positive findings with certain skin irritants interfere with the accuracy of the method.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Stolzenseeweg 32 – 36, 88353 Kißlegg, Germany
- Age at study initiation: 30-32 days
- Weight at study initiation: 325-381 g (test group); 312-365 g (positive reference group)
- Housing: in pairs
- Diet: ssniff® Ms-H V2233, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days
- Indication of any skin lesions: Animals even if only slightly injured by shaving were replaced

ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C
- Humidity: 55% ± 15%
- Air changes (per hr): not specified
- Photoperiod: 12-hour light / 12-hour dark

IN-LIFE DATES:
From: 2010-11-03
To: 2011-04-09
Route:
intradermal
Vehicle:
other: Aqua ad iniectabilia
Concentration / amount:
5% suspension
Day(s)/duration:
Study day 0, single injection
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
other: Aqua ad iniectabilia
Concentration / amount:
25 % suspension
Day(s)/duration:
Study day 7, exposure period: 48 hours
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: Aqua ad iniectabilia
Concentration / amount:
10 % suspension
Day(s)/duration:
Study day 21, exposure period: 24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Preliminary study: 2 animals (0.01, 0.1, 0.5, 1, 5 or 10 % suspension by intracutaneous application); 3 animals (10, 25, 50 and 75 % suspension by topical administration)
Main experiment: 20 animals (5 % suspension by intracutaneous injection; 10 % and 25 % suspension by topical administration); 10 animals (vehicle control); 20 animals (positive control from a historical background group from a study performed during October 2010)
Details on study design:
RANGE FINDING TESTS: yes

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 pairs of intracutaneous injections; 1 topical application
- Exposure period: 48 hours
- Test groups: yes
- Control group: vehicle control was conducted; positive control from historical data
- Site: shoulder region (intracutaneous); shoulder region (topical)
- Frequency of applications: 3 consecutive pairs of intracutaneous injections; 1 single topical application
- Duration: Study day 0 and 7
- Concentrations: 5 % and 25 % in aqua ad iniectabilia

B. CHALLENGE EXPOSURE
- No. of exposures: 1 topical application
- Day(s) of challenge: Study day 21
- Exposure period: 24 hours
- Test groups: yes
- Control group: vehicle control was conducted; positive control from historical data
- Site: flank region (topical)
- Concentrations: 10 % in aqua ad iniectabilia
- Evaluation: 48 and 72 hours
Positive control substance(s):
yes
Remarks:
- not concurrently conducted - 10% (v/v) α-hexyl cinnamic aldehyde solution intracutaneously in stage 1, - undiluted α-hexyl cinnamic aldehyde topically in stage 2 - 0.01% α-hexyl cinnamic aldehyde solution in stage 3
Positive control results:
Animals of this strain treated with 0.01% α-hexyl cinnamic aldehyde in sesame oil exhibited a sensitizing reaction in all animals in form of a discrete or patchy erythema (grade 1).
Group:
negative control
Remarks on result:
not measured/tested
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.01% α-hexyl cinnamic aldehyde solution
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
Discrete or patchy erythema on the left flank and no visible change on the right flank of all animals.
Remarks on result:
positive indication of skin sensitisation
Remarks:
The positive control group was not tested concurrently with this study but is a historical background group from a study performed during October 2010.
Reading:
2nd reading
Hours after challenge:
72
Group:
positive control
Dose level:
0.01% α-hexyl cinnamic aldehyde solution
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
Discrete or patchy erythema on the left flank and no visible change on the right flank of all animals.
Remarks on result:
positive indication of skin sensitisation
Remarks:
The positive control group was not tested concurrently with this study but is a historical background group from a study performed during October 2010.
Reading:
1st reading
Hours after challenge:
48
Group:
other: vehicle control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
72
Group:
other: vehicle control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no skin irritation in any animal
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no skin irritation in any animal
Remarks on result:
no indication of skin sensitisation
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification

Fenpropimorph does not need to be classified for skin sensitizing properties according to EC/1272/2008.