Registration Dossier
Registration Dossier
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EC number: 614-264-5 | CAS number: 68081-77-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- yes
- Principles of method if other than guideline:
- On day 7, the 24-hour scoring interval for all test males and females was performed at 25 hours 1 minute to 25 hours and 20 minutes following chamber removal. Animal No. G1944/F was not shaved on day -1 but prior to dosing (day 0) and allowed to rest for aproximately 30 minutes prior to dosing. The animal room relative humidity (31-73%) was outside the preferred range (30-70%) on one occasion during the study. These deviations had no impact on the validity of the study or the interpretation of the study results.
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): AL305B
- Physical state: clear, colourless, slightly viscous liquid
- Smiles notation (if other than submission substance): Not stated
- InChl (if other than submission substance): Not stated
- Structural formula attached as image file (if other than submission substance): Not stated
- Physical state: Clear, colourless liquid
- Analytical purity: 100%
- Impurities (identity and concentrations): Not applicable
- Composition of test material, percentage of components: Not applicable
- Isomers composition: Not stated
- Purity test date: Not stated
- Lot/batch No.: TS07003
- Expiration date of the lot/batch: 1 March 2008
- Radiochemical purity (if radiolabelling): Not applicable
- Specific activity (if radiolabelling): Not applicable
- Locations of the label (if radiolabelling): Not applicable
- Expiration date of radiochemical substance (if radiolabelling): Not applicable
- Stability under test conditions: Not stated
- Storage condition of test material: Room temperature
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Saint Constant, Quebec
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 340-444 g the day prior to dosing
- Housing: suspended stainless steel cages
- Diet (e.g. ad libitum): PMI Certified Guinea Pig Chow #5026 ad libitum
- Water (e.g. ad libitum): municipal tap water treated by reserve osmosis available ad libitum
- Acclimation period: a minium of five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22
- Humidity (%): 31-73
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- 0.3 mL test dose of the test material placed on a 25-mm Hilltop chamber backed by adhesive tape
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: mineral oil
- Concentration / amount:
- 0.3 mL test dose of the test material placed on a 25-mm Hilltop chamber backed by adhesive tape
- No. of animals per dose:
- 10 male/10 female
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Site: Not stated
- Frequency of applications: every 7 days
- Duration: 7 days
- Concentrations: 100%
- Evaluation: 24 and 48 hr after challenge
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 6 hours
- Test groups: 1
- Control group: 1
- Site: Not stated
- Evaluation (hr after challenge): graded for irritation at chamber removal - Challenge controls:
- See above
- Positive control substance(s):
- yes
- Remarks:
- alpha-Hexylcinnamaldehyde (HCA)
Study design: in vivo (LLNA)
- Vehicle:
- other: LLNA test not performed
- Positive control substance(s):
- other: Not applicable
Results and discussion
- Positive control results:
- Positive
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
The test animals gained weight during the test period and appeared in good health.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test material is not considered to be a skin sensitiser under the conditions of this test
- Executive summary:
In lin with OCED Guideline 209, the dermal sensitisation potential of AL305B was evaluated in guinea pigs. Ten male and 10 female animals were topically treated with 100% AL305B once per week for three consecutive weeks. Following an approximate two-week rest-period, a challenge was performed where 20 test and 10 previously untreated animals were topically treate with 10% w/w AL305B. Following a further two-week rest period, the 20 test and 10 previously untreated aniamls were topically treated with 25% and 10% w/w AL305B.
Under the conditions of this test, AL305B does not meet the criteria to be considered a sensitiser.
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