Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 939-518-5 | CAS number: 68439-49-6
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 Mar - 12 May 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted in 1992
- Deviations:
- yes
- Remarks:
- room temperature in the animal room was 22 ± 3 °C instead of 20 ± 3 °C as recommended by the guideline
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministerium für Umwelt, Raumordnung und Landwirtschaft des Landes Nordrhein-Westfalen, Düsseldorf, Germany
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An in vivo skin sensitisation study is available that was performed prior to 1 June 2008. In accordance with Regulation (EC) No. 1907/2006, the data were included to avoid unnecessary testing.
Test material
- Reference substance name:
- Hexadecan-1-ol
- EC Number:
- 253-149-0
- EC Name:
- Hexadecan-1-ol
- Cas Number:
- 36653-82-4
- Molecular formula:
- C16H34O
- IUPAC Name:
- hexadecan-1-ol
- Reference substance name:
- 2-(hexadecyloxy)ethanol
- EC Number:
- 218-373-5
- EC Name:
- 2-(hexadecyloxy)ethanol
- Cas Number:
- 2136-71-2
- Molecular formula:
- C18H38O2
- IUPAC Name:
- 2-(hexadecyloxy)ethanol
- Reference substance name:
- 2-[2-(Hexadecyloxy)ethoxy]ethanol
- EC Number:
- 610-892-9
- Cas Number:
- 5274-61-3
- Molecular formula:
- C20H42O3
- IUPAC Name:
- 2-[2-(Hexadecyloxy)ethoxy]ethanol
- Reference substance name:
- 2-[2-[2-(Hexadecyloxy)ethoxy]ethoxy]ethanol
- Cas Number:
- 4484-59-7
- Molecular formula:
- C22H46O
- IUPAC Name:
- 2-[2-[2-(Hexadecyloxy)ethoxy]ethoxy]ethanol
- Reference substance name:
- 2-[2-[2-(2-hexadecoxyethoxy)ethoxy]ethoxy]ethanol
- Cas Number:
- 5274-63-5
- Molecular formula:
- C24H50O5
- IUPAC Name:
- 2-[2-[2-(2-hexadecoxyethoxy)ethoxy]ethoxy]ethanol
- Reference substance name:
- Octadecan-1-ol
- EC Number:
- 204-017-6
- EC Name:
- Octadecan-1-ol
- Cas Number:
- 112-92-5
- Molecular formula:
- CH3(CH2)17OH
- IUPAC Name:
- octadecan-1-ol
- Reference substance name:
- 2-(octadecyloxy)ethanol
- EC Number:
- 218-374-0
- EC Name:
- 2-(octadecyloxy)ethanol
- Cas Number:
- 2136-72-3
- Molecular formula:
- C20H42O2
- IUPAC Name:
- 2-(octadecyloxy)ethanol
- Reference substance name:
- 2-[2-(Octadecyloxy)ethoxy]ethanol
- EC Number:
- 605-213-8
- Cas Number:
- 16057-43-5
- Molecular formula:
- C22H46O3
- IUPAC Name:
- 2-[2-(Octadecyloxy)ethoxy]ethanol
- Reference substance name:
- 2-[2-[2-(Octadecyloxy)ethoxy]ethoxy]ethanol
- EC Number:
- 610-180-8
- Cas Number:
- 4439-32-1
- Molecular formula:
- C24H50O
- IUPAC Name:
- 2-[2-[2-(Octadecyloxy)ethoxy]ethoxy]ethanol
- Reference substance name:
- 2-[2-[2-(2-octadecoxyethoxy)ethoxy]ethoxy]ethanol
- Cas Number:
- 59970-10-4
- Molecular formula:
- C26H54O5
- IUPAC Name:
- 2-[2-[2-(2-octadecoxyethoxy)ethoxy]ethoxy]ethanol
- Reference substance name:
- 2-[2-[2-[2-(2-octadecoxyethoxy)ethoxy]ethoxy]ethoxy]ethanol
- Cas Number:
- 71093-13-5
- Molecular formula:
- C28H58O6
- IUPAC Name:
- 2-[2-[2-[2-(2-octadecoxyethoxy)ethoxy]ethoxy]ethoxy]ethanol
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Constituent 9
Constituent 10
Constituent 11
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- Pirbright White Hsd/Win:DH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Versuchstierzucht, Borchen, Germany
- Age at study initiation: Healthy young adults, not further specified
- Weight at study initiation: < 500 g
- Housing: Conventional housing, max, 5 animals per cage in Macrolon cage (type IV)
- Diet: Ssniff G 4-Alleindiät für Meerschweinchen, Ssniff Spezialfutter GmbH, Soest, Germany, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 6 Mar To: 12 May 1995
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 6 h
- Adequacy of induction:
- other: Test substance did not cause skin irritation.
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 6 h
- Adequacy of challenge:
- other: Test substance did not cause skin irritation.
- No. of animals per dose:
- 10 (controls), 20 (in test groups)
- Details on study design:
- RANGE FINDING TESTS:
The left and right flanks of three animals was clipped 2 - 3 h prior to application. Formulations containing 5, 25 and 50% test substance in maize oil were prepared by heating the test subtance. 0.3 mL of test formulations as well as unchanged test substance (without vehicle) were applied to gauze patches (2 cm x 2 cm). Four gauze patches were then applied to the clipped skin of the animals as follows:
- left flank, anterior part: 5%
- left flank, posterior part: 25%
- right flank, anterior part: 50%
- right flank, posterior part: 100%
Patches were fixed under occlusive conditions for 6 h. After patch removal, the test sites were gently cleaned with vehicle and a soft tissue. Skin reactions were scored 36 and 60 h after start of the application. No skin reactions occured in any animal at any time point. Therefore, a concentration of 100% test substance (unchanged, without vehicle) was chosen for the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: Unchanged test substance
- Control group: Maize oil
- Site: left flank
- Frequency of applications: Every 7 days
- Duration: Days 0-14
- Concentrations: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 28
- Exposure period: 6 h
- Test groups: Unchanged test substance and maize oil
- Control group: Unchanged test substance and maize oil
- Site: Posterior right flank (test substance) and anterior right flank (vehicle)
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 h after patch removal - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- no
- Remarks:
- Historical control data provided in study report
Results and discussion
- Positive control results:
- The results of a positive control test (7 Nov - 2 Dec 1994) are provided in the study report. The positive control substance 2-mercaptobenzothiazol (2-MCBT) induced skin sensitisation in 9/10 test animals.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no systemic effects observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no systemic effects observed
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: 100%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no systemic effects observed
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 100%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no systemic effects observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Induction: 2.5%; challenge: 50%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- no systemic effects observed
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Historical control data provided in study report
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Induction: 2.5%; challenge: 50%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- no systemic effects observed
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Historical control data provided in study report
Any other information on results incl. tables
No signs of systemic or local toxicity were noted in any animal.
Detailed tables are attached as pdf documents under 'Attached background material'.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- The test substance did not induce skin sensitisation in a Buehler test according to OECD guideline 406.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
