Registration Dossier
Registration Dossier
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EC number: 278-306-0 | CAS number: 75782-86-4
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
- Study period:
- 26 May 1998 to 19 June 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
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
Test material
- Reference substance name:
- Alcohols, C10-16
- EC Number:
- 267-019-6
- EC Name:
- Alcohols, C10-16
- Cas Number:
- 67762-41-8
- IUPAC Name:
- tetradecan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Compound 33A (also known as Safol(TM) 23 Alcohol) (C10-16 alcohols Type B ). Equivalent to Alcohols, C12-13-branched and linear (CAS 740817-83-8)
- Substance type: technical product
- Physical state: clear liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: mainly C12-C13 alcohols
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: KPT/SAS/DA/2/98
- 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:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: 4 weeks
- Weight at study initiation: 213-275 g
- Housing: 10 animals per cage (treated group); 5 animals per cage (control group)
- Diet (e.g. ad libitum): conventional; ad libitum
- Water (e.g. ad libitum): tap water; ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 54-70 (94 for up to 1 hr due to cleaning or meteorological conditions)
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 26-May-1998 To: 19-Jun-1998
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- 1st application: Induction 30 % intradermal
2nd application: Induction 100 % occlusive epicutaneous
3rd application: Challenge 100 % occlusive epicutaneous
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 1st application: Induction 30 % intradermal
2nd application: Induction 100 % occlusive epicutaneous
3rd application: Challenge 100 % occlusive epicutaneous
- No. of animals per dose:
- 10 in treatment group
5 in control group - Details on study design:
- RANGE FINDING TESTS: various concentrations of the test material were tested in groups of 2 animals to determine the concentrations causing slight to moderate irritation for the intradermal and epicutaneous inductions and a non-irritant level for the epicutaneous challenge. Concentrations tested were: intradermal injections (0.1 ml) 3, 10, 30 and 100%.; epicutaneous application 30 and 100%
MAIN STUDY
A. INDUCTION EXPOSURE
Epidermal injection:
- No. of exposures: 1
- Test groups: 3 pairs of injections (0.1 ml) - 1:1 Freund's Complete Adjuvant:saline; test material in saline; test material in 1:1 Freund's Complete Adjuvant:saline;
- Control group: 1:1 Freund's Complete Adjuvant:saline; saline; 1:1 Freund's Complete Adjuvant:saline
- Site: shoulder region
- Frequency of applications: once
- Duration: day 1
- Concentrations: 30%
Epicutaneous application:
- No. of exposures: 1
- Exposure period: 48 hours
- Test groups: test material in saline
- Control group: untreated patch
- Site: over the sites of the intradermal injections
- Frequency of applications: once
- Duration: day 8-10 (after application of a 10% dilution of sodium lauryl sulphate in Vaseline on day 7)
- Concentrations: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 22
- Exposure period: 24 hours
- Test groups: right flank treated with test material
- Control group: right flank treated with test material
- Site: right flank
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 hr - Challenge controls:
- Control animals were injected with saline instead of the test material; for the topical induction period they received an untreated patch; challenged with the test material at the same concentration as the test group
- Positive control substance(s):
- yes
- Remarks:
- not tested concurrently, but at approximately 6-month intervals
Study design: in vivo (LLNA)
- Positive control substance(s):
- other: formaldehyde
- Statistics:
- not applicable
Results and discussion
- Positive control results:
- The challenge treatment with a 10% test dilution of formaldehyde (37%) elicited a positive skin reaction in the majority of test animals, but there were no skin reactions in the control animals.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none reported after challenge
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none reported after challenge.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none reported after challenge
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none reported after challenge.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none reported after challenge
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none reported after challenge.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none reported after challenge
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none reported after challenge.
Any other information on results incl. tables
RESULTS OF PILOT STUDY:
Intradermal - no irritation at test sites with 3,10 or 30% solutions in saline. The undiluted material caused abscesses, necrosis and incrustation.
Topical - no irritation at either 30 or 100%.
MAIN TEST:
- Clinical signs of irritation after induction by injection:
moderate erythema in treated and controls receiving FCA/saline, and controls receiving FCA/vehicle (grade 2),
intense erythema and swelling with necrosis and incrustation in test animals with test
substance/FCA.
- Rechallenge: Not required
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- In a reliable study, conducted to OECD guideline 406, Compound 33A (C10-16 alcohols Type B) was not a skin sensitiser when tested using a 100% challenge dose in a guinea pig maximization test. The study was performed to GLP.
Classification: not sensitizing
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