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EC number: 218-145-5 | CAS number: 2052-25-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From: September 07, 1999 To: October 08, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 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:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test was not valid at time of test conduct
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name: Diamantechtrot BT
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HARLAN WINKELMANN, Gartenstr. 27, 33178 Borchen, Germany, SPF breeding colony
- Weight at study initiation: mean = 353 g; min = 331 g; max = 385 g; n = 15
- Housing: in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet (e.g. ad libitum): ssniff Ms-H (V2233), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C
- Humidity (%): 50±20%
- Photoperiod (hrs dark / hrs light): 12 hours daily
IN-LIFE DATES: From: September 07, 1999 To: October 08, 1999
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Remarks:
- deionized
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) i.d.: 5 % deionized water
b) e.d.: 25 % deionized water
Concentration of test material and vehicle used for each challenge: 25 % deionized water
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- deionized
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) i.d.: 5 % deionized water
b) e.d.: 25 % deionized water
Concentration of test material and vehicle used for each challenge: 25 % deionized water
- No. of animals per dose:
- Determination of the primary non-irritant concentration – 2 animals
Determination of the tolerance of the intradermal injections – 2 animals
Control group – 5 animals
Treatment group -10 animals - Details on study design:
- RANGE FINDING TESTS:
Determination of the primary non-irritant concentration:
The following test concentrations were administered to the flanks of 2 guinea pigs:
25.0 % in deionized water; 5.0 % in deionized water; 1.0 % 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 deionized water
Site 2. 2X0.1 mL 1.0 % in deionized water
Site 3. 2X0.1 mL 0.2 % 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 % test substance in sesame oil
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 sesame oil
- Control group: Yes, sesame oil
- Site: Dorsal area
- Frequency of applications: Single on Day 8
- Concentrations: 25.0 % test substance in sesame oil
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: An amount of 0.5 mL 25.0 % test substance in sesame oil
- Control group:
- Site: Left flank
- Concentrations: 25 % test substance in sesame oil
- Evaluation (hr after challenge): 24 and 48 h after removal of the patches - Positive control substance(s):
- yes
- Remarks:
- alpha-hexyl cinnamic aldehyde
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- 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:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- 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:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 25 %
The intradermal injections with FCA (with and without test
substance) caused well-defined up to severe erythema and
oedema as well as indurations and encrustations. The
administration sites treated with the test substance in
deionized water showed well-defined up to severe erythema
and oedema. Intradermal injections of the vehicle alone
exhibited no signs of irritation.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Testing for sensitizing properties of Diamantechtrot BT was performed in female guinea pigs according to the method of MAGNUSSON & KLIGMAN.
Based on the results of this study Diamantechtrot BT showed no evidence for sensitizing properties. - Executive summary:
Testing for sensitizing properties of Diamantechtrot BT was performed in female guinea pigs according to the method of MAGNUSSON & KLIGMAN.
Intradermal induction was performed using 5 % Diamantechtrot BT in deionized water.
Dermal induction and challenge treatment were carried out with 25 % Diamantechtrot BT 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 (report number 99.0220, dated May 14, 1999; Hoechst Marion Roussel Deutschlang GmbH, ProTox).
Under the conditions of the present study, none of ten animals of the treatment group showed a positive skin response after the challenge procedure.
Based on the results of this study Diamantechtrot BT showed no evidence for sensitizing properties.
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