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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 619-269-6 | CAS number: 97398-80-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan 29 - Sep 24, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1996
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- With the existing data from this study not only being acceptable but of good quality (Klimisch Score 1), this study precludes the need for an additional LLNA study. In addition, a supplementary LLNA study would violate the ECHA objectives with regards to animal welfare.
Test material
- Reference substance name:
- (1r,1's,4r,4'r)-4-methoxy-4'-propyl-1,1'-bi(cyclohexane)
- EC Number:
- 619-269-6
- Cas Number:
- 97398-80-6
- Molecular formula:
- C₁₆H₃₀O
- IUPAC Name:
- (1r,1's,4r,4'r)-4-methoxy-4'-propyl-1,1'-bi(cyclohexane)
- Test material form:
- liquid: viscous
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: HsdPoc:DH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen
- Age at study initiation: about 6 weeks
- Weight at study initiation: The mean initial body weight at the start of the study was 363 g (range from 337 to 391 g).
- Housing: Five guinea pigs were housed in type GM/5 (EBECO) Makrolon cages with a shelter and placed on mobile racks.
- Diet: ad libitum, Provimi Kliba 3418.0
- Water: ad libitum, tap water
- Acclimation period: 7 days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 23
- Humidity (%): 55 to 60
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 50g/L/0.1 mL
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 50 g/L
- Day(s)/duration:
- Day 8/48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 10 g/L
- Day(s)/duration:
- Day 22/24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Pretest: 5 females
Group 1: negative control group (5 females)
Group 2: test material group (10 females) - Details on study design:
- RANGE FINDING TESTS:
- no pretreatment, intradermal injection: 0, 1, 5, 10, 25, 50 g/L given to one animal in paraffin oil
- topical applications (48 h), no pretreatment: 1, 10, 50, 100, and 200 g/L in polyethylene glycol 400
- topical applications (24 h), FCA pretreatment: 1, 5, 10, and 50 g/L in polyethylene glycol 400
MAIN STUDY
A1. INDUCTION EXPOSURE (intradermal injection)
- No. of exposures: 6 injections of 0.1 mL each, three on each side of the spinal column
- Test groups: 0.1 mL FCA + NaCl, 0.1 mL 50g/L test item ad liquid paraffin, 0.1 mL FCA + 50 g/L test item in NaCl solution
- Control group: 0.1 mL FCA + NaCl, 0.1 mL liquid paraffin, 0.1 mL FCA + NaCl- Site: cranial, medial, caudal
- Frequency of applications: single
A2. INDUCTION EXPOSURE (topical application)
- No. of exposures: one week after injection (A1) single topical application of a filter plate soaked with either test solution, or vehicle
- Test groups: 50 g/L test material ad PEG 400
- Control group: PEG 400
- Site: cranial, medial, caudal- Frequency of applications: single
- Duration: 48 h, occlusive
B. CHALLENGE EXPOSURE
- No. of exposures: single two weeks after topical induction (A2)
- Day(s) of challenge: 1d
- Exposure period: 2 weeks after topical application
- Test groups: 10 g/L test item ad PEG 400- Control group: PEG 400
- Site: cranial, medial, caudal
- Evaluation (hr after challenge): 48 and 72 h
- Observations
During the induction phase, the guinea pigs were examined on days 2, 3, 7, 11, 12, 15, and 22 of the experimental part for local skin reactions and the results were documented.The behavior and general condition of all animals were monitored daily. The challenge sites were investigated for reactions 48 hours after start of the challenge. Further inspections followed 72 hours after start of the challenge, to detect weak or slowly developing reactions. After the challenge, skin changes at the application sites were evaluated according to the following MAGNUSSON and KLIGMAN scheme. - Positive control substance(s):
- yes
- Remarks:
- Hexylcinnamaldehyde
Results and discussion
- Positive control results:
- 50% positive reactions with control substance
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no signs of toxicity
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no signs of toxicity
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 10 g/L
- No. with + reactions:
- 5
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the given experimental conditions, the test material induced no skin sensitization.
- Executive summary:
The test material was investigated for skin sensitizing properties in the guinea pig maximization test according to MAGNUSSON and KLIGMAN (1969). 5 females were treated with the vehicles liquid paraffin and polyethylene glycol 400 (group 1) and 10 females were treated with the test material (group 2). Induction included intradermal injection of the test material preparation in liquid paraffin (50 g/L with and without Freund's complete adjuvant) on experimental day 1, and topical application of test material preparation in polyethylene glycol 400 (50 g/L) for 48 hours on experimental day 8.
Challenge by topical application of the test material preparation in polyethylene glycol 400 (10 g/L) for 24 hours was performed two weeks after topical induction and readings were taken at 48 hours and 72 hours after start of treatment.
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. After challange no positive reactions were seen 48 or 72 hours after treatment with the test material.
Under the given experimental conditions, the test material induced no skin sensitising reactions.
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.
