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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 204-781-0 | CAS number: 126-30-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP; guideline study (OECD 429)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2,2-dimethylpropane-1,3-diol
- EC Number:
- 204-781-0
- EC Name:
- 2,2-dimethylpropane-1,3-diol
- Cas Number:
- 126-30-7
- Molecular formula:
- C5H12O2
- IUPAC Name:
- 2,2-dimethylpropane-1,3-diol
- Details on test material:
- Purity: 99.3%
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld
- Age at study initiation: 8 – 12 weeks
- Weight at study initiation: 17.0 g – 21.0 g
- Housing: single housed
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 24°C
- Humidity (%): 30 – 70%
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 60% (w/w); maximum technically applicable concentration
- No. of animals per dose:
- 5
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- SI
- Value:
- 0.98
Any other information on results incl. tables
Treatment |
Cell Count Stimulation Index1 |
Cell Count Stimulation Index HC2 |
³H-thymidine incorporation Stimulation Index1 |
³H-thymidine incorporation Stimulation Index HC2 |
Lymph Node Weight Stimulation Index |
Ear Weight Stimulation Index |
vehicle propylene glycol |
1.00 |
|
1.00 |
|
1.00 |
1.00 |
60% in propylene glycol |
0.98 |
1.24 |
0.90 |
2.22 |
1.05 |
1.00 |
1Stimulation Index (SI) calculated using the concurrent vehicle group
2Stimulation Index (SI) calculated using the historical control (HC) data for the vehicle propylene glycol
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Neopentylglycol does not show a skin sensitizing effect in the Murine Local Lymph Node Assay under the test conditions chosen.
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.
