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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-375-0 | CAS number: 106-22-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: only secondary literature, but sound abstract, according to OECD and EPA guidelines and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Remarks:
- no further data given
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Citronellol
- EC Number:
- 203-375-0
- EC Name:
- Citronellol
- Cas Number:
- 106-22-9
- Molecular formula:
- C10H20O
- IUPAC Name:
- 3,7-dimethyloct-6-en-1-ol
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Housing: 4 per cage
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
A total of 24 female CBA/Ca mice were divided into 6 groups consisting of 4 animals in each group. Groups included 1 control (vehicle) group and 5 test groups. Animals were housed 4 per cage in an environmentally controlled animal room with a room temperature of 22+/-3° C, relative humidity of 30 - 70%, a minimum of 15 air changes per hour, and a 12 hour light/dark cycle. Food and water were available ad libitum. The control group was treated with the vehicle only. Animals were checked at least once daily for signs of systemic toxicity and body weights were recorded prior to treatment and prior to injection with methyl thymidine.
Study design: in vivo (LLNA)
- Vehicle:
- other: 1:3 ethanol:diethyl phthalate
- Concentration:
- 50, 25, 10, 5 and 2.5%
- No. of animals per dose:
- 4
- Details on study design:
- study length: 3 days
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: Test material
was regarded as a sensitizer in the LLNA if one or more concentrations of the test material elicited a
3-fold or greater increase in isotope incorporation relative to the vehicle control group (SI>/= 3.0).
TREATMENT PREPARATION AND ADMINISTRATION:
- A volume of approximately 25 ul of 5 different concentrations of test material (%v/v) in a vehicle of 1:3 ethanol:diethyl phthalate was applied topically to the dorsum of each ear lobe (left and right) on three consecutive days. - Positive control substance(s):
- not specified
- Statistics:
- (EC3) was calculated by interpolating between two SI points using the following equation; EC3 = [(3 - d)/(b - d)] x (a - c) + c, where a = concentration with SI immediately above 3, b = SI of a, c = concentration with SI immediately below 3, and d = SI of c.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 50% -> SI = 3.6 -> sensitization effects 25% -> SI = 1.3 -> no effects 10% -> SI = 1.0 -> no effects 5% -> SI = 1.2 -> no effects 2.5% -> SI = 1.6 -> no effects
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 50% -> DPM per LN: 1206 25% -> DPM per LN: 443 10% -> DPM per LN: 315 5% -> DPM per LN: 398 2.5% -> DPM per LN: 512
Any other information on results incl. tables
Under the conditions of the test, the test material in ethanol:diethyl phthalate (1:3) was classified as a likely sensitizer with an EC3 value of 43.5% w/v or 10875 ug/cm² based on the classification scheme of Basketter 2000 and Gerberick, 2001.
The test material showed sensitization effects at 50% with a stimulation index of 3.6.
The test material was not a sensitizer at 25% with a stimulation index of 1.3.
The test material was not a sensitizer at 10% with a stimulation index of 1.0.
The test material was not a sensitizer at 5% with a stimulation index of 1.2.
The test material was not a sensitizer at 2.5% with a stimulation index of 1.6.
Applicant's summary and conclusion
- Interpretation of results:
- other: likely sensitising
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.
