Registration Dossier
Registration Dossier
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EC number: 939-249-3 | CAS number: 97926-05-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 Oct 1997 - 27 May 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD) (test substance purity not specified).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 17 July, 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- adopted 30 Sept 1996
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Alcohols, C12-14-secondary, β-(2-hydroxyethoxy)
- EC Number:
- 308-219-6
- EC Name:
- Alcohols, C12-14-secondary, β-(2-hydroxyethoxy)
- Cas Number:
- 97926-05-1
- IUPAC Name:
- 97926-05-1
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Epicol G24 G2, C12/14alpha-Epoxid, ringgeöffnet mit Glykol, SAT970397
- Analytical purity: not specified
- Lot/batch No.: 10017020
- Expiration date of the lot/batch: 1998-01-20
- Storage condition of test material: at room temperature in the dark
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 Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: 30 days
- Weight at study initiation: 303g ± 19g
- Housing: in Makrolon Type 4 cages with up to 5 animals per cage in semi-barrier conditions
- Diet: Altromin 1322, standard diet for guinea pigs, ad libitum
- Water: tap water, municipal supply Bitterfeld in Makrolon bottles, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 24°C
- Humidity (%): 30 - 65%
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted
- No. of animals per dose:
- control - 10
test group - 20 - Details on study design:
- RANGE FINDING TESTS: A dermal tolerance test was done for the test substance. Shaved skin of 2 guine pigs was treated with different aqueous dilutions of the substance for 24 hours.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: filter papaer soaked with 0.5 g test substance
- Control group: filter paper with occlusive dressing
- Site: left flank
- Frequency of applications: every 7 days
- Duration: 0-21 days
- Concentrations: undiluted
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 28
- Exposure period: 6 hours
- Test groups: filter paper soaked with 0.5 g test substance
- Control group: filter paper soaked with 0.5 g test substance
- Site: right flank
- Concentrations: undiluted
- Evaluation (hr after challenge): 24 and 48 hours
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no skin reactions and no differences in skin-fold thickness
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no skin reactions and no differences in skin-fold thickness.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no skin reactions and no differences in skin-fold thickness
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no skin reactions and no differences in skin-fold thickness.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DSD: not classified
CLP: not classified
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