Registration Dossier
Registration Dossier
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EC number: 605-546-9 | CAS number: 169280-10-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 30, 2001 to January 30, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to international guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was performed between 2001 and 2002, which is before the OECD guideline for the LLNA method was adopted (2002).
Test material
- Reference substance name:
- 4-(Cyclopropylcarbonyl)-α,α-dimethyl-ethyl ester benzeneacetic acid
- EC Number:
- 605-546-9
- Cas Number:
- 169280-10-8
- Molecular formula:
- C16 H20 O3
- IUPAC Name:
- 4-(Cyclopropylcarbonyl)-α,α-dimethyl-ethyl ester benzeneacetic acid
- Details on test material:
- Batch: W0147
Physical state: powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Diet: Raiffeisen-Ringfutter, Kaninchen Trockenfutter 52/P, Raiffesen Kraftfutterwerk Kehl
Water: Community tap water from Karlsruhe: free access for the animals by daily changing of the watering-bottles.
Husbandry: animals housed individually in Makrolon cages (740 cm²)
Temperature: 20-23 °C
Relative humidity: 30-70%
Light-dark rythm: 12 : 12
Animals were acclimated to the test conditions for 5 days prior to the administration.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5 % for intradermal injection;
50% for epicutaneous challenge.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5 % for intradermal injection;
50% for epicutaneous challenge.
- No. of animals per dose:
- 10 in the test group (5 males and 5 females);
5 in the control group. - Details on study design:
- 2 small scale pilot tests were performed to determine the intradermal and challenge concentration using each 3 animals. The main study consisted of 5 days of acclimatization, followed by the induction phase (day 0 to 7) with an intradermal administration on day 0 and a dermal one on day 7 followed by a 14 days rest period (day 8 to day 20). The challenge was started by dermal administration on day 21 with subsequent valuation of potential sensitisation reactions on days 23 and 24.
- Challenge controls:
- Present.
- Positive control substance(s):
- yes
- Remarks:
- benzocaine, cas. 94-09-7
Results and discussion
- Positive control results:
- Six out of the ten animals exposed showed symptoms of allergic reactions.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- No effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: No effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- No effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: No effects.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to a Magnuson-Kligman test, the substance is considered to have no skin sensitizing potential.
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