Registration Dossier
Registration Dossier
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EC number: 941-188-2 | CAS number: -
Toxicological information
Skin sensitisation
Currently viewing:
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
- Study period:
- no data (report year is 1984)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- (some details missing from report)
- Principles of method if other than guideline:
- Magnusson & Kligman maximization test
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Alcohols, C14-16
- EC Number:
- 269-790-4
- EC Name:
- Alcohols, C14-16
- Cas Number:
- 68333-80-2
- IUPAC Name:
- pentadecan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Lial 145 (C14-16 alcohols Type A). Equivalent to alcohols, C14-15-branched and linear (no CAS)
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Padre Antonio, Mariano Comense, CO, Italy
- Age at study initiation: no data
- Weight at study initiation: 250-300 g
- Housing: 5 animals per polycabonate cage with sawdust bedding
- Diet (e.g. ad libitum): conventional, ad libitum
- Water (e.g. ad libitum): filtered tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 55 +/- 15
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: where FCA was used the test material was dissolved in this. It is unclear what vehicle was used for the injection without FCA or for epicutaneous induction
- Concentration / amount:
- Intradermal induction: 0.1 g (or 0.1 ml; both terms are used in the report)
Epicutaneous induction: 0.5 g (or 0.5 ml)
Challenge: 1.0 g (or 1.0 ml)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: where FCA was used the test material was dissolved in this. It is unclear what vehicle was used for the injection without FCA or for epicutaneous induction
- Concentration / amount:
- Intradermal induction: 0.1 g (or 0.1 ml; both terms are used in the report)
Epicutaneous induction: 0.5 g (or 0.5 ml)
Challenge: 1.0 g (or 1.0 ml)
- No. of animals per dose:
- 20 in treated group
10 in control group - Details on study design:
- RANGE FINDING TESTS: no data
MAIN STUDY
A. INDUCTION EXPOSURE
INTRADERMAL INJECTION
- No. of exposures: 1
- Test groups: 3 pairs of injections - Freund's Complete Adjuvant, test material emulsified in Freund's Complete Adjuvant; test material (in vehicle ?)
- Control group: 3 pairs of injections - Freund's Complete Adjuvant, (vehicle in?) Freund's Complete Adjuvant; vehicle ? (Where FCA was used the test material was dissolved in this. It is unclear what vehicle was used for the injection without FCA or for epicutaneous induction.)
- Site: dorsal region
- Frequency of applications: once
- Duration: day 0
- Concentrations: 0.1 ml (or 0.1 g, both terms are used in the report)
EPICUTANEOUS APPLICATION
- No. of exposures: 1
- Exposure period: 48 hours
- Test groups: test material (it is unclear whether a vehicle was used)
- Control group: it is unclear whether the control group received an application of vehicle
- Site: dorsal region just behind injection site
- Frequency of applications: once
- Duration: day 7-9 (on day 6 the animals were treated with 10% sodium lauryl sulphate in petrolatum to induce mild irritation)
- Concentrations: 0.5 ml (or 0.5 g, both terms are used in the report)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: days 20-21
- Exposure period: 24 hours
- Test groups: 0.5 ml of the test material applied to each flank
- Control group: 0.5 ml of the test material applied to each flank
- Site: flanks
- Concentrations: total per animal 1.0 ml (or 1.0 g, both terms are used in the report)
- Evaluation (hr after challenge): immediately after removal of the patch and 24 and 48 hours later - Challenge controls:
- Control (non-induced) animals were treated with 0.5 ml of the test material on each flank region (total applied 1.0 ml)
- Positive control substance(s):
- not required
Study design: in vivo (LLNA)
- Statistics:
- not applicable, negative result
Results and discussion
- Positive control results:
- not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1.0 ml
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none reported
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1.0 ml. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none reported.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.0 ml
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none reported
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1.0 ml. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none reported.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1.0 ml
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none reported
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1.0 ml. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none reported.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1.0 ml
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none reported
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1.0 ml. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none reported.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- In a reliable study conducted using a protocol similar to OECD guideline 406, Lial 145 (C14-16 alcohols Type A) was not a skin sensitiser in guinea pigs (maximization procedure of Magnusson & Kligman).
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