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EC number: 436-060-3 | CAS number: - FC 84508 PK
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Aug. 29, 2000 to Nov. 28, 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was already available
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): FC 84508
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White guinea pig (HsdPoc:DH strain)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HARLAN WINKELMANN Gartenstr. 27, D-33178 Borchen, SPF breeding colony
- Weight at study initiation: 362 g
- Housing: Macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet: ssniff Ms-H (V2233), ad libitum
- Water: Tap water in plastic bottles, ad libitum
- Acclimation period: At least 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C
- Humidity (%): 50±20 °C
IN-LIFE DATES: From: Aug. 29, 2000 To: Sep. 29, 2000
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Tylose H 4000 G4 PHA (0.5 % in deionized water)
- Concentration / amount:
- 5% / 2 x 0.1 mL
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Tylose H 4000 G4 PHA (0.5 % in deionized water)
- Concentration / amount:
- 25 % /0.5 mL
- Day(s)/duration:
- Day 8 / 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Tylose H 4000 G4 PHA (0.5 % in deionized water)
- Concentration / amount:
- 25 % / 0.5 mL
- Day(s)/duration:
- Day 22 / 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- - Determination of the primary non-irritant concentration: 2
- Determination of the tolerance of the intradermal injections: 3
- Control group: 5
- Treatment group: 10 - Details on study design:
- RANGE FINDING TESTS:
Determination of the primary non-irritant concentration:
The following test concentrations were administered to the flanks of two guinea pigs:
25.0 % in Tylose H 4000 G4 PHA (0.5 % in deionized water)
5.0 % in Tylose H 4000 G4 PHA (0.5 % in deionized water)
1.0 % in Tylose H 4000 G4 PHA (0.5 % in deionized water)
0.5 mL of the test substance preparation was administered to a 2 x 2 cm cellulose patch, which was fixed to the flank and covered occlusively for 24 h with a bandage and film. 24 h after removal of the patches, the treated skin areas were examined for erythema and edema.
Determination of the tolerance of the intradermal injections:
The following preparations were administered twice by intradermal injection to 2 guinea pigs:
Site 1. 2X0.1 mL 5.0 % in Tylose H 4000 G4 PHA (0.5 % in deionized water)
Site 2. 2X0.1 mL 1.0 % in Tylose H 4000 G4 PHA (0.5 % in deionized water)
Site 3. 2X0.1 mL 0.2 % in Tylose H 4000 G4 PHA (0.5 % in deionized water)
24, 48, 72 and 96 h after administration the injection sites were examined for local tolerance.
MAIN STUDY
A. INDUCTION EXPOSURE (Intradermal)
- No. of exposures: 2
- Exposure period: 1-7 d
- Test groups: Yes
- Control group: Yes, (50 % Freund's Adjuvant)
- Site: Dorsal area
- Frequency of applications: 2 in 7 d
- Duration: 7 d
- Concentrations: 5.0 % in Tylose H 4000 G4 PHA (0.5 % in deionized water)
INDUCTION EXPOSURE (Dermal)
- No. of exposures: 0.5 mL of the test substance preparation as cellulose patch
- Test groups: Yes, 25.0 % test substance in Tylose H 4000 G4 PHA (0.5 % in deionized water)
- Control group: Yes, Tylose H 4000 G4 PHA (0.5 % in deionized water)
- Site: Dorsal area
- Frequency of applications: Single on Day 8
- Concentrations: 25 % in Tylose H 4000 G4 PHA (0.5 % in deionized water)
B. CHALLENGE EXPOSURE (Dermal)
- No. of exposures: One
- Day(s) of challenge: Day 22
- Exposure period: 24 h under an occlusive bandage covered with an impermeable film and an elastic bandage.
- Test groups: 25.0 % test substance in Tylose H 4000 G4 PHA (0.5 % in deionized water)
- Control group:
- Site: Left flank
- Concentrations: 25 %
- Evaluation (hr after challenge): 24 and 48 h after removal of the patches
OTHER:
The substance is considered to be sensitizing if 30 % or more of the animals in the treatment group definitely showed a positive skin reaction and at the same time no irritant effects have emerged in the control group. - Positive control substance(s):
- yes
- Remarks:
- Alpha-hexyl cinnamic aldehyde
Results and discussion
- Positive control results:
- Alpha-hexyl cinnamic aldehyde was skin sensitiser and proved to be suitable for the determination of dermal sensitizers
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25 % Alpha-hexyl cinnamic aldehyde in PEG 400
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
After the challenge treatment, none of the ten animals of the treatment group showed a positive skin reaction during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test substance showed no evidence for sensitizing properties in guinea pigs.
- Executive summary:
A study was conducted to assess the sensitizing potential of the test substance in female Pirbright-White guinea pigs (Magnusson & Kligman method) according EU Method B.6. and OECD guideline 406 in compliance with GLP.
Intradermal induction was performed using 5 % test substance in Tylose H 4000 G4 PHA (0.5 % in deionized water). Dermal induction and challenge treatment were carried out with 25 % test substance in Tylose H 4000 G4 PHA (0.5 % in deionized water).
The validity of the test system is confirmed by the periodically conducted positive control test using alpha-hexyl cinnamic aldehyde for the maximization test.
Under the test conditions, the test substance showed no evidence for sensitizing properties in guinea pigs.
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