Registration Dossier
Registration Dossier
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EC number: 944-011-7 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979-05-23 to 1979-07-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Non-GLP study conducted similarly to OECD Guideline 406 with deviations: no details on test animals and environmental conditions; no. of animals in control groups < 5
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- non-GLP study; no details on test animals and environmental conditions; no. of animals in control groups < 5
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA not available at the time of testing.
Test material
- Reference substance name:
- 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl pivalate
- EC Number:
- 268-259-4
- EC Name:
- 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl pivalate
- Cas Number:
- 68039-44-1
- Molecular formula:
- C15H22O2
- IUPAC Name:
- 3a,4,5,6,7,7a-hexahydro-1H-4,7-methanoinden-6-yl pivalate
- Reference substance name:
- 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl pivalate
- EC Number:
- 268-261-5
- EC Name:
- 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl pivalate
- Cas Number:
- 68039-45-2
- Molecular formula:
- C15H22O2
- IUPAC Name:
- 3a,4,5,6,7,7a-hexahydro-1H-4,7-methanoinden-5-yl pivalate
- Reference substance name:
- rel-(1R,2S,3aR,4S,5R,6aS,7R)-octahydro-1,5:2,4-dimethanopentalen-7-yl pivalate
- Molecular formula:
- C15H22)2
- IUPAC Name:
- rel-(1R,2S,3aR,4S,5R,6aS,7R)-octahydro-1,5:2,4-dimethanopentalen-7-yl pivalate
- Test material form:
- other: liquid, may crystalize to white solid
Constituent 1
Constituent 2
impurity 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): PM 343 Pivaloxycyclene
- Source: PPL, UK
- Analytical purity: 100 %
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: males: 312-360 g; females: 316-364 g
- Diet (e.g. ad libitum): R12 pellets, hay and cabbage; ad libitum
- Water (e.g. ad libitum): Ad libitum
Study design: in vivo (non-LLNA)
- No. of animals per dose:
- Preliminary test: 4 males (intradermal injection and topical application)
Main test:
- Treatment group: 6 males and 4 females (challenges 1, 2 and 3)
- Treated control group: 4 males (challenge 1)
- Untreated control group: 4 females (challenge 1); 4 males (challenges 2 and 3) - Details on study design:
- PRELIMINARY TEST:
- Intradermal injection: Four male guinea pigs received intradermal injections (0.1 mL) of test material at concentrations of 0.1, 0.25, 0.5 and 1.0 % on the clipped flanks and evaluated for local reactions at 24 h after injections.
- Topical application: Filter paper (8 mm diameter) patches, in 11 mm aluminium patch test cups, were saturated with 1, 2.5, 5, 10 and 25 % of test material. These cups were applied on the shaved flanks of four male guinea pigs via occlusive patches for 24 h and evaluated for cutaneous reactions at 24 and 48 h after removal of the patches.
MAIN STUDY
A. INDUCTION EXPOSURE: INTRADERMAL
- No. of exposures: One
- Test groups: Intradermally injected with 2 injections each of 0.1 mL of Freund’s Complete Adjuvant (FCA) (50 % v/v in vehicle), 1 % test material in vehicle and 1 % test material in a 50/50 mixture of FCA in vehicle on Day 1.
- Treated control group: Intradermally injected with 2 injections each of 0.1 mL of FCA (50 % v/v in vehicle), vehicle and a 50/50 mixture of FCA in vehicle on Day 1.
- Site: 6 different sites (2 x 4 cm) on shoulder region
- Duration: Days 1-7
B. INDUCTION EXPOSURE: TOPICAL
- No. of exposures: One
- Exposure period: 48 h
- Test groups: Filter paper patches (2 x 4 cm) saturated with 10 % test material were topically applied over the shoulder injection sites on Day 8 via occlusive patch.
- Treated control group: Filter paper patches saturated with vehicle alone were topically applied on Day 8 via occlusive patch.
- Site: Shoulder region
- Frequency of applications: Single application
- Duration: Days 8-21
C. CHALLENGE EXPOSURE: TOPICAL
- No. of exposures: Three
- Days of challenge: Days 22, 28 & 43
- Exposure period: 24 h
- Test group: Filter paper patch (8 mm diameter) in a patch test cup was saturated with 1 % test material and the cup was topically applied to the shaved flank on Day 22 via occlusive patch. After intervals of 1 week or more days, 1 and 0.5 % test material were applied for challenges 2 and 3, respectively.
- Site: Shaved flank
- Evaluation (h after removal of challenge patch): 24 and 48 h - Challenge controls:
- - Treated control groups: Filter paper patches (8 mm diameter) saturated with 1 % test material were topically applied on Day 22 via occlusive patches.
- Untreated control groups: Filter paper patches (8 mm diameter) saturated with 1 % test material were topically applied on Days 22, 28 and 43 via occlusive patches. - Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- Not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: challenges 1 and 2: 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no data
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: challenges 1 and 2: 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no data
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: challenge 3: 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no data
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: challenge 3: 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- no data
Any other information on results incl. tables
- No skin reactions to barely perceptible erythema were noted at the challenge sites in treatment and control group animals at the 24 and 48-h post challenge observations.
- During the second reading of third challenge (48-h after challenge), assessment of the application site in one test animal was considered to be difficult by the author due to dry and scaly appearance of the skin. Mild erythema was visible in this animal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under these test conditions, PM 343 Pivaloxycyclene is not classified according to the Directive 67/548/EEC and the CLP Regulation.
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