Registration Dossier
Registration Dossier
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EC number: 931-287-9 | CAS number: 120944-67-4
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
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:
- (some details omitted from report, including data on any reliability checks performed)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Alcohols, C14-15
- EC Number:
- 616-261-4
- Cas Number:
- 75782-87-5
- IUPAC Name:
- Alcohols, C14-15
- Details on test material:
- - Name of test material (as cited in study report): Dobanol 45
- Substance type: no data
- Physical state: no data
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: C14-15 chain length synthetic primary fatty alcohol
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: Batch 119, ex Tank 4614
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
- Other:
- Receipt date: 25-May-1978
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: 'P' strain
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Shell Toxicology Laboratory (Tunstall) Breeding Unit
- Age at study initiation: 8-12 weeks
- Weight at study initiation: no data
- Housing: 5/cage in hanging stainless steel cages with all mesh floors and tops and half mesh fronts
- Diet (e.g. ad libitum): SG1 with vitamin C supplement, ad libitum
- Water (e.g. ad libitum): public supply, 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:
- intradermal induction: 1% w/v
epicutaneous induction: 50% w/v
epicutaneous challenge: 25% w/v
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- intradermal induction: 1% w/v
epicutaneous induction: 50% w/v
epicutaneous challenge: 25% w/v
- No. of animals per dose:
- 10/sex in test group
5/sex in control group - Details on study design:
- RANGE FINDING TESTS: yes
- 2/sex intradermally injected with 0.1 ml of several dilutions (usually 0.05, 0.1, 0.5 and 1.0%)
- examined over next few days to determine maximum intradermal concentration that could be used without untoward toxicity
- further groups of 2/sex patch tested with 0.3 ml of several concentrations occluded for 48 hours and examined for skin irritation
- concentration selected for topical induction in the main study was that which just caused irritation and for topical challenge was that which was just non-irritant
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2, intradermal and epicutaneous
- Exposure period: occluded for 48 hours
- Test groups: 10/sex; intradermal: 2x0.1 ml injections of each of Freund's complete adjuvant (FCA), test material in corn oil, test material in 50:50 FCA:corn oil; epicutaneous: 0.3 ml test material in corn oil on 4 x 4cm filter paper
- Control group: 5/sex; intradermal: 2x0.1 ml injections of each of FCA, corn oil, 50:50 FCA:corn oil; epicutaneous: 0.3 ml corn oil on 4 x 4 cm filter paper
- Site: shoulder region
- Frequency of applications: epicutaneous 1 week after intradurmal
- Duration: epicutaneous on day 0, intradermal from day 7-9
- Concentrations: intradermal 1% w/v; epicutaneous 50% w/v
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 21
- Exposure period: 24 hours
- Test groups: 0.15 ml test material in corn oil on 2 x 2 cm filter paper
- Control group: 0.15 ml test material in corn oil on 2 x 2 cm filter paper
- Site: flank
- Concentrations: 25%
- Evaluation (hr after challenge): 0, 24 and 48 hours after end of challenge exposure
OTHER: - Challenge controls:
- control (non-induced) animals challenged with test material in the same manner as test (induced) animals
- Positive control substance(s):
- no
Study design: in vivo (LLNA)
- Statistics:
- none
Results and discussion
- Positive control results:
- none
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:
- no data
- 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: no data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no data
- 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: no data.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no data
- 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: no data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no data
- 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: no data.
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, Dobanol 45 (a mixture of C14-15 alcohols) was not sensitising to the skin of guinea pigs.
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