Registration Dossier
Registration Dossier
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: 203-542-8 | CAS number: 108-01-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1 July - 10 August 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Older guideline followed but results valid, sufficient documentation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EPA 40 CFR Part 158
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Bühler test with Guinea pigs was performed before the LLNA was set as preferred test method.
Test material
- Reference substance name:
- 2-dimethylaminoethanol
- EC Number:
- 203-542-8
- EC Name:
- 2-dimethylaminoethanol
- Cas Number:
- 108-01-0
- Molecular formula:
- C4H11NO
- IUPAC Name:
- 2-(dimethylamino)ethanol
- Details on test material:
- - Name of test material (as cited in study report): 00272 Dimethylaminoethanol
- Molecular formula (if other than submission substance): na
- Molecular weight (if other than submission substance): na
- Smiles notation (if other than submission substance): na
- Substance type: clear liquid
- Physical state: liquid
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Expiration date of the lot/batch: no data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Davidson's Mill Farm, South Brunswick, NJ
- Age at study initiation: no data
- Weight at study initiation: 332 - 451g
- Housing: 5 per cage (stainless steel)
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: 24d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 66 - 72F
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: From: 1 July To: 10 August 1988
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 6%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 6%
- No. of animals per dose:
- 15
- Details on study design:
- RANGE FINDING TESTS:
2 guinea pigs tested with 50, 25, 12.5 and 6.25 % each. 6% was established as highest non-irritating dose
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 6h
- Test groups: 10 induced + 5 naive GPs
- Control group: Positive control 10 induced + 5 naive GPs
- Site: thoracolumbar region
- Frequency of applications: 48h
- Duration: 6h
- Concentrations: 6%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge:after 14d
- Exposure period: 6h
- Test groups: 10 induced + 5 naive GPs
- Control group: Positive control 10 induced + 5 naive GPs
- Site: thoracolumbar region, left side
- Concentrations: 6%
- Evaluation (hr after challenge): 24 and 48h - Positive control substance(s):
- yes
- Remarks:
- 0.08% DNCB in 95% ethanol
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: Dimethylaminoethanol does not cause contact sensitization after 10 applications at its HNID (6% w/w in distilled water) over a 3 1/2 week induction period; No details specified on negative control results.
- Group:
- negative control
- Dose level:
- no details given on negative control
- Remarks on result:
- other: Reading: other:
- Remarks:
- No details given on negative control. Dimethylaminoethanol does not cause contact sensitization after 10 applications at its HNID (6% w/w in distilled water) over a 3 1/2 week induction period; No details specified on negative control results.
- Reading:
- other: Dimethylaminoethanol does not cause contact sensitization after 10 applications at its HNID (6% w/w in distilled water) over a 3 1/2 week induction period.
- Group:
- test chemical
- Dose level:
- no details given
- Remarks on result:
- other: Reading: other:
- Remarks:
- Dimethylaminoethanol does not cause contact sensitization after 10 applications at its HNID (6% w/w in distilled water) over a 3 1/2 week induction period..
- Reading:
- other: Dimethylaminoethanol does not cause contact sensitization after 10 applications at its HNID (6% w/w in distilled water) over a 3 1/2 week induction period; No details specified on positive control results.
- Group:
- positive control
- Dose level:
- no details given on positive control
- Remarks on result:
- other: Reading: other:
- Remarks:
- No details given on positive control. Dimethylaminoethanol does not cause contact sensitization after 10 applications at its HNID (6% w/w in distilled water) over a 3 1/2 week induction period; No details specified on positive control results.
Any other information on results incl. tables
Dimethylaminoethanol does not cause contact sensitization after 10 applications at its HNID (6% w/w in destilled water) over a 3 1/2 week induction period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Dimethylaminoethanol does not cause contact sensitization after 10 applications at its HNID (6% w/w in destilled water) over a 3 1/2 week induction period.
- Executive summary:
DMAE was tested on skin sensitization potential in guinea pigs. The test substance did not cause sensitization after challenge exposure.
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.
