Registration Dossier
Registration Dossier
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EC number: 279-420-3 | CAS number: 80206-82-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: published data
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- In a reliable study, conducted to OECD guideline 406, Kalcol 2098 (Dodecan-1-ol (C12) was not a skin sensitiser in guinea pigs. The study was performed in compliance with GLP.
Test material
- Reference substance name:
- Dodecan-1-ol
- EC Number:
- 203-982-0
- EC Name:
- Dodecan-1-ol
- Cas Number:
- 112-53-8
- Molecular formula:
- C12H26O
- IUPAC Name:
- dodecan-1-ol
- Details on test material:
- Name of test material (as cited in study report): Kalcol 2098 (lauryl alcohol)-Dodecan-1-ol (C12) is supporting substance for Alcohols,C12-C14 and the main component.- Analytical purity: <=98%- Impurities (identity and concentrations): no data- Composition of test material, percentage of components: no data- Isomers composition: no data- Purity test date: no data- Lot/batch No.: 3531- Expiration date of the lot/batch: no data- Stability under test conditions: no data- Storage condition of test material: room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Japan SLC Co.
- Age at study initiation: 5 weeks
- Weight at study initiation: 304 to 355 g
- Housing: 5/cage; aluminium cages with stainless steel wire mesh floors (350 x 400 x 200 mm)
- Diet (e.g. ad libitum): standard pelleted guinea pig diet (RC-4), ad libitum
- Water (e.g. ad libitum): tap water 5 um-filtered, ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +- 2
- Humidity (%): 50 +- 10
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 24-Jun-1997 To: 04-Sep-1997
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: liquid paraffin
- Concentration / amount:
- 3 and 6% intracutaneous induction, 50% epicutaneous induction; 3 and 10% epicutaneous challenge
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: liquid paraffin
- Concentration / amount:
- 3 and 6% intracutaneous induction, 50% epicutaneous induction; 3 and 10% epicutaneous challenge
- No. of animals per dose:
- 10 test, 5 control
- Details on study design:
- RANGE FINDING TESTS:
- 8 females
- concentrations for intracutaneous application: 10, 5, 3, 1, 0.3, 0.1, 0% in liquid paraffin
- concentrations for occluded epicutaneous application (presumably 7 days later): undiluted, 30 and 10% in liquid paraffin
- evaluated for skin irritation at 24, 48 and 72 hours after intracutaneous application
- evaluated for skin irritation at 3, 24 and 48 hours after epicutaneous application
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2, intracutaneous and occluded epicutaneous
- Exposure period: epicutaneous induction 7 days after intracutaneous induction; epicutaneous challenge 21 days after intracutaneous induction
- Test groups: 10 females
- Control group: 5 females
- Site: intracutaneous induction in the shaved skin area (~ 4 x 6 cm), symmetrically on both sides of the midline in the scapular region, test animals received (a), (b) and (c), controls received (a), (d) and (a); epicutaneous induction at initially exposed skin site shaved again, test animals received (e), control animals received (d)
- Frequency of applications: epicutaneous induction 7 days after intracutaneous induction
- Duration: epicutaneous induction 48 hours
- Concentrations: (a) 1:1 water-in-oil emulstion of Freunds complete adjuvant (FCA) and physiological saline, (b) test material at 3% in liquid paraffin, (c) 1:1 emulsion of test material at 6% in FCA and physiological saline, (d) liquid paraffin, (e) 0.2 ml of test substance at 50% in liquid paraffin
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21 days after intracutaneous induction
- Exposure period: 24 hours occlusive
- Test groups: 10 females
- Control group: 5 females
- Site: flank, clipped and shaved
- Concentrations: (f) 0.1 ml test substance at 10, 3 and 0% in liquid paraffin
- Evaluation (hr after challenge): 24 and 48 hours after removal of patches
OTHER:
- General condition
- Body weight
- Rechallenge: not required - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitrochlorobenzene and formalin, not concurrent, results from 12 tests at same testing facility
Results and discussion
- Positive control results:
- Evidence presented over a relevant time period that the strain of guinea pig did respond to known sensitisers
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- challenge: 0, 3 and 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: challenge: 0, 3 and 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- challenge: 0, 3 and 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: challenge: 0, 3 and 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- challenge: 0, 3 and 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: challenge: 0, 3 and 10%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- challenge: 0, 3 and 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: challenge: 0, 3 and 10%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no effects.
Any other information on results incl. tables
RESULTS OF PILOT STUDY: Following intradermal injection significant skin irritation was seen at concentrations of 5 and 10% persisting for 72 hours. The 3% concentration showed evidence of irritation at 24 hours only. Following topical application the undiluted material was irritant up to 48 hours, 2/4 guineapigs showed irritation at 10% while there was no evidence of irritation with the 3% concentration.
RESULTS OF TEST
- Sensitization reaction: There was no evidence of sensitisation in any of the test animals. Reactions at 24 and 48 hours following challenge with the solvent control (liquid paraffin) and 3% and 10% solutions were 0/10 treated, 0/5 control.
- Clinical signs: There were no significant differences in general condition and body weight gain between test and control groups over the course of the test.
- Rechallenge: Not required.
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitising
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In a reliable study, conducted to OECD guideline 406, Kalcol 2098 (Dodecan-1-ol (C12) was not a skin sensitiser in guinea pigs. The study was performed in compliance with GLP.
- Executive summary:
In a reliable study, conducted to OECD guideline 406, Kalcol 2098 (Dodecan-1-ol (C12) was not a skin sensitiser in guinea pigs. The study was performed in compliance with GLP.
Dodecan-1-ol (C12) is supporting substance for Alcohols,C12-C14 and the main component.
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