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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | CAS number: -
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-01-06 to 2015-03-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 17 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 31 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The Buehler test was conducted because the test substance is also subject to other registration processes outside EU, where a skin sensitisation study according to OECD guideline 406 is mandatory.
Test material
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 003
- Expiration date of the lot/batch: January 2020
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient (RT), no direct sunlight, hygroscopic
- Stability under test conditions: stable
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories GmbH, NL-5800 AN Venray
- Microbiological status of animals, when known: SPF
- Weight at study initiation: 280 - 338 g
- Housing: groupwise (2 - 3 aniamls) in one macrolone cage (floor area 2280 cm²)
- Diet: ad libitum, pelleted diet "Altromin 3123" (Altromin, D-32791 Lage, Lippe, Germany)
- Water: ad libitum, vitamin C enriched domestic quality water
- Acclimation period: at least 5 days
- Indication of any skin lesions: No
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- 50 % (w/w) test item / 0.5 mL
- Day(s)/duration:
- Day 1, 7, 14 / 6 hours
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- 50 % (w/w) test item / 0.5 mL
- Day(s)/duration:
- Day 28 / 6 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 (test group); 10 (control group)
- Details on study design:
- RANGE FINDING TESTS: The skin irritant effect was observed during a range finding test. Three animals were exposed to 4 concentrations each on the left and rigt anterior and posterior flank. Animals were treated with 5, 10, 25 and 50 % solutions of the test item. Skin reactions were read after 24 and 48 hours. The follwing grading scale was used:
no visible change 0
discrete or patchy erythema 1
moderate and confluent erythema 2
intense erythema and swelling 3
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: Patch of multi-layered gauze (2.5 x 2.5 cm) coated occlusive with impermeable tape (Blenderm ™) on one side was saturated with 0.5 mL of the 50 % (w/w) test item and the patch was placed on the skin of all the animals in the test group.
- Control group: was treated in the same manner, but with the vehicle aqueous 1 % (w/w) CMC only.
- Site: left flank region
- Frequency of applications: 3 times
- Duration: 7 days per treatment
- Concentrations: 50 % (w/w) in CMC
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 28
- Exposure period: 6 hours
- Test group: a patch of multi-layered gauze (2.5 x 2.5 cm) coated occlusive with impermeable tape (Blenderm ™) on one side was saturated with 0.5 mL of the 50 % (w/w) test item. The patch was placed on the skin of the anterior part of the right flank. In the same way an occlusive coated patch of multi-layered gauze (2.5 x 2.5 cm) was saturated with 0.5 ml of the vehicle 1 % (w/w) CMC and placed on the posterior part of the right flank.
- Control group: treated like the test group.
- Site: right flank region
- Concentrations: 50 % (w/w) in CMC
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- The challenge control was treated similarly to the test group.
- Positive control substance(s):
- yes
- Remarks:
- a-Hexylcinnamaldehyde
Results and discussion
- Positive control results:
- The last positive control test with the reference material a-Hexylcinnamaldehyde, technical grade, 85 % was performed from December 2014 until January 2015. The sensitization potential of the positive reference item has been sufficiently shown by the response of 18 of 20 guinea pigs (90 %) of the test group with positive skin reactions (erythema with grade 1 and 2).
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 % test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 % test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 % test substance
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 % test substance
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
No skin irritation effects were observed during preliminary investigation with three animals at concentrations of 5, 10, 25 and 50 % test substance in CMC.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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.
