Registration Dossier
Registration Dossier
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EC number: 629-693-3 | CAS number: 740817-83-8
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:
- 1978
- 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:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- (no data on any reliability check performed)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Alcohols, C12-13
- EC Number:
- 278-306-0
- EC Name:
- Alcohols, C12-13
- Cas Number:
- 75782-86-4
- IUPAC Name:
- dodecan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Dobanol 23 (C10-16 alcohols Type C)
- Substance type: technical product
- Physical state: liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: C12-C13 chain length synthetic primary fatty alcohol
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: 118 ex Tank 4611
- 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:
- other: 'P' strain
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Shell Breeding Unit, Sittingbourne, Kent, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: no data
- Housing: 5 per cage in stainless steel cages with mesh floors and tops and half mesh fronts
- Diet (e.g. ad libitum): conventional with vitamin C supplement; ad libitum
- Water (e.g. ad libitum): filtered tap water, ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 5%
- Air changes (per hr): 15
- 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:
- corn oil
- Concentration / amount:
- 1st application: Induction 0.05 % intradermal
2nd application: Induction 50 % occlusive epicutaneous
3rd application: Challenge 25 % occlusive epicutaneous
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 1st application: Induction 0.05 % intradermal
2nd application: Induction 50 % occlusive epicutaneous
3rd application: Challenge 25 % occlusive epicutaneous
- No. of animals per dose:
- 10/sex - treatment group
5/sex - control group - Details on study design:
- RANGE FINDING TESTS: yes, to determine concentrations for main test: maximum concentration for injection without causing toxicity; epicutaneous concentration just causing irritation for induction; concentration for challenge which was just nonirritating.
MAIN STUDY
A. INDUCTION EXPOSURE - intradermal
- No. of exposures: 1
- Exposure period: not applicable
- Test groups: three paired injections (0.01 ml): Freund's Complete Adjuvant, test material in corn oil, test material in 50:50 corn oil:Freund's Complete Adjuvant
- Control group: Freund's Complete Adjuvant, corn oil, 50:50 corn oil:Freund's Complete Adjuvant
- Site: shoulder region, each side of midline
- Frequency of applications: once
- Duration: day 1
- Concentrations: 0.05%
A. INDUCTION EXPOSURE - epicutaneous
- No. of exposures: 1
- Exposure period: 48 hr
- Test groups: test material in corn oil
- Control group: corn oil
- Site: over injection site
- Frequency of applications: once
- Duration: day 8-10
- Concentrations: 50%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 22-23
- Exposure period: 24 hr
- Test groups: test material in corn oil
- Control group: test material in corn oil
- Site: flank
- Concentrations: 25%
- Evaluation (hr after challenge): immediately, 24 and 48 hr - Challenge controls:
- yes
- Positive control substance(s):
- no
Study design: in vivo (LLNA)
- Statistics:
- none
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:
- 25%
- 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: 25%. 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:
- 25%
- 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: 25%. 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:
- 25%
- 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: 25%. 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:
- 25%
- 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: 25%. 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, carried out using a protocol similar to OECD guideline 406 (Magnusson and Kligman maximization test) Dobanol 23 (C12-C13 chain length synthetic primary fatty alcohol) did not induce sensitization in male and female guinea pigs.
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