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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 255-137-0 | CAS number: 40908-37-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11.06.1997 to 27.08.1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The described guinea pig sensitisation test (Buehler test) according to OECD 406 was conducted in 1997 before the guidance for the LLNA (OECD429, first adopted in 2002) was available, and before the method was fully established and validated. And since the result of the Buehler test is considered to be scientifically valid, the test was not repeated also taking into account exposure and animal welfare considerations.
Test material
- Reference substance name:
- N-(2,2,6,6-tetramethylpiperidin-4-yl)acetamide
- EC Number:
- 255-137-0
- EC Name:
- N-(2,2,6,6-tetramethylpiperidin-4-yl)acetamide
- Cas Number:
- 40908-37-0
- Molecular formula:
- C11H22N2O
- IUPAC Name:
- N-(2,2,6,6-tetramethylpiperidin-4-yl)acetamide
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- The described guinea pig sensitisation test (Buehler test) according to OECD 406 was conducted in 1997 before the guidance for the LLNA (OECD429, first adopted in 2002) was available, and before the method was fully established and validated. And since the result of the Buehler test is considered to be scientifically valid, the test was not repeated also taking into account exposure and animal welfare considerations.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- Pirbright White HsdPoc: DH [SPF]
- Sex:
- female
Study design: in vivo (non-LLNA)
Induction
- Vehicle:
- petrolatum
Challenge
- Vehicle:
- petrolatum
- No. of animals per dose:
- 20
- Details on study design:
- 1st application: Induction 50 % occlusive epicutaneous
2nd application: Induction 50 % occlusive epicutaneous
3rd application: Induction 50 % occlusive epicutaneous
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
Any other information on results incl. tables
0/20 test animals and 0/10 controls showed a positive skin reaction after challenge (30 and 54 h p.a.)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a Buehler guinea pig test for skin sensitization no animal in the control and test groups showed any sign for skin sensitization. Thus, the available data on skin sensitization of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
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.
