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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 807-422-1 | CAS number: 66918-01-2
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: guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- , relative humidity during husbandry was between approx. 30-84%. This deviation did not affect the validity of this study
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1,4-bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] 2-hydroxybutanedioate
- Cas Number:
- 66918-01-2
- Molecular formula:
- C40H78O5
- IUPAC Name:
- 1,4-bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] 2-hydroxybutanedioate
- Details on test material:
- - Name of test material (as cited in study report): SALACOS 222
- Physical state: liquid
- Analytical purity: > 98%
- Lot/batch No.: 7-2-D
- Expiration date of the lot/batch: 04/10
- Stability under test conditions: stable
- Storage condition of test material: room temperature (20 +/- 5 °C)
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands, Horst, NL
- Age at study initiation: 7-8 wks (beginning of acclimatisation)
- Weight at study initiation: 18-22 g
- Housing: single (Makrolon Type I, granulated soft wood bedding)
- Diet (e.g. ad libitum): pelleted standard diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 - 84 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 25, 50, and 100 %
- No. of animals per dose:
- 4
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 0%: -, 25%: 3.20, 50%: 4.23, 100%: 6.75
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 0%: 5584, 25%: 17841, 50%: 23598, 100%: 37691
Any other information on results incl. tables
No deaths occurred during the study period, and no symptoms of local toxicity at the ears of the animals and no systemic findings were observed. The body weights of the animals was within the range commonly recorded for this strain and age during the whole study period.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test item was found to be a skin sensitiser under the described conditions. Since the S.I. was increased above the threshold pf 3 even at the lowest tested concentration an EC3 value could not be derived. The presented study should be considered as adequate and reliable for classification of the test item.
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.
