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Diss Factsheets

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:
In-life initiated/completed: 25-June-1996 to 26-July-1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Version / remarks:
not specified
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
Previously known as EEC B.6.
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was performed to the OECD test guideline (OECD 406) in place at the time (1996), and therefore predates the adoption of the LLNA (OECD 429) in 2002. The study is scientifically valid and adequate for hazard assessment and classification purposes.

Test material

1
Reference substance name:
3-(3,5-Dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutanoate
Cas Number:
148477-71-8
Molecular formula:
C21H24Cl2O4
IUPAC Name:
3-(3,5-Dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutanoate
Test material form:
solid: particulate/powder

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Remarks:
Hsd PoC:DH
Sex:
female
Details on test animals and environmental conditions:
A total of 25 female animals were used in the study, including those employed in the range-finding tests to determine the induction and challenge concentrations.

Acclimatisation: Following receipt, the animals scheduled for this study were adapted to the maintenance conditions for a period of at least seven days before treatment, and their state of health was monitored.

State of health: Only healthy animals exhibiting no clinical signs were used for the study. The animals were not vaccinated or treated against infections either before receipt, or during the adaptation or study periods. The females were nulliparous and non-pregnant.

Age and body weight: The guinea pigs exhibited a mean weight of 288-295 grams at the beginning of the study. This weight corresponds to an age of 5 - 7 weeks.

During the adaptation and study period the animals were conventionally kept in type IV Makrolon® cages [4], in groups of five during the adaptation period and in groups of two or three per cage throughout the study period. The cages were exchanged for ones with clean bedding two times per week. Low-dust wood shavings were used as bedding. The wood shavings were spotchecked for contaminant levels. Records of these test results are filed at BAYER AG. The analytical results provided no evidence for an effect on the study objective. All animals used in this study were kept in the same animal room, one in which guinea pigs from other sensitization studies were also housed. Adequate separation, unambiguous cage markings and suitable organization of the work ensured that animals were not mixed up.

The animal room was swept out with a broom each day, and thoroughly cleaned with water once weekly. The room was disinfected at least once each month with Zephirol® 10% (10 grams benzalkonium chloride per 100 grams disinfectant; working dilution 2%, corresponding to 20 ml per liter of water). Contamination of the diet and contact with the experimental animals were avoided during this work. No pest control measures were carried out in the animal rooms. KILLIGERM Roach Traps ®, a cockroach trap which uses no pesticides, was placed in the animal room from July 10, 1996.

Diet: The diet consisted of "Altromin®3020 - Maintenance Diet for Guinea Pigs" and of tap water. Food and water were provided ad libitum.

Climatic Conditions:
Room temperature: 22 +/- 3°C (possibly drifting higher at outdoor temperatures above 24°C)
Relative humidity: 40 - 60 %
Light/dark cycle: Twelve hours; artificial lighting from 6 AM to 6 PM CET
Air exchange rate: >= 10 times per hour

Occasional deviations from these standards occurred at times including the period following the cleaning of the animal room. They had no apparent effect in the course of the study.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
0.5 ml Spirodiclofen 50% in physiological saline solution containing 2% Cremophor EL®
Day(s)/duration:
48 hours
Adequacy of induction:
other: Performed one week after intradermal induction.
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
No test substance used - complete Freund's adjuvant only
Adequacy of induction:
not specified
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
5% Spirodiclofen formulated in physiological saline solution containing 2% Cremophor EL®
Adequacy of induction:
not specified
Route:
intradermal
Vehicle:
physiological saline
Remarks:
and complete Freund's adjuvant.
Concentration / amount:
5% Spirodiclofen formulated at equal parts in sterile physiological saline solution and
complete Freund's adjuvant.
Adequacy of induction:
not specified
Challengeopen allclose all
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
50% test substance formulation - The volume applied in each case was 0.5 ml. shaved right flank of the animals is where the test substance was applied.
Day(s)/duration:
24 hours
Adequacy of challenge:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
50% test substance formulation - The volume applied in each case was 0.5 ml. shaved left flank of the animals is where the test substance was applied.
Day(s)/duration:
24 hours
Adequacy of challenge:
not specified
No. of animals per dose:
10 animals in main study group, 5 in the control group and 5 in the dose range-finding group.
Details on study design:
The test substance was formulated in sterile physiological saline solution containing 2% Cremophor EL to yield a suspension. A 5% concentration was used for intradermal, and a 50% concentration for topical induction. A 50% concentration was used for the first and second challenge.
Challenge controls:
Yes - a 50% formulated substance of the test material was used for both Challenges.
Positive control substance(s):
no

Results and discussion

Positive control results:
N/A

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
72
Group:
positive control
Dose level:
NA
Clinical observations:
NA
Remarks on result:
not measured/tested
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
NA
Clinical observations:
NA
Remarks on result:
not measured/tested
Key result
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
50% test substance formulation
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
None
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% test substance formulation
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
None
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
72
Group:
negative control
Dose level:
Vehicle only
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
Vehicle only
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
Spirodiclofen showed evidence of skin sensitisation potential under the conditions of this study.
Executive summary:

The skin sensitisation potential of spirodiclofen was investigated in a Guinea Pig Maximization Test (GPMT) using female Dunkin-Hartley guinea pigs.  The study was conducted using concentrations of 5% for intradermal induction and 50% for topical induction.  Two challenge applications were made, using 50% test material.  The test material was formulated in physiological saline solution containing 2% Cremophor EL to yield a suspension.  The first and the second challenge resulted in skin reactions in 4 of 10 (40%) animals in the test group and 0 of 10 animals in the control group. However, only one animal showed a positive reaction in both challenge treatments.  Spirodiclofen showed evidence of skin sensitisation potential under the conditions of this study, and requires classification as a skin sensitiser (Cat 1B) according to the CLP criteria.