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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 939-180-9 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Key study: Equivalent to EU method B.6. No data on GLP.
A Magnusson and Kligman maximisation test was performed to determine the sensitising potential of the test substance. The percentage of animals showing a positive response after treatment with the test substance was ≥35% in all the test groups. The substance is considered to be a skin sensitiser.
Justification for selection of skin sensitisation endpoint:
Klimisch 2. Equivalent to EU method B.6. No data on GLP.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Equivalent to EU method B.6. No data on GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- Magnusson and Kligman maximisation test
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An appropriate guinea pig maximisation test is available which would not justify conducting an additional LLNA due to animal welfare.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Weight at study initiation: 350 g
- Housing: The animals were housed individually in polypropylene cages
- Diet (e.g. ad libitum): Sterilized granules (UAR 114); ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 ± 1 ºC
- Humidity (%): 50 ± 5%
- Air changes (per hr): 15 cycles/hour
- Photoperiod (hrs dark / hrs light): light - dark cycle 12 h:12 h - Route:
- intradermal and epicutaneous
- Concentration / amount:
- Nº1:
Induction: 1 and 3 % p/v (in water)
Challenge: 0.5 % p/v (in water)
Nº2:
Induction: 1 and 3 % p/v (in water)
Challenge: 0.5 % p/v (in water)
Nº3:
Induction: 0.5 and 3 % p/v (in propylene glycol)
Challenge: 0.5 % p/v (in propylene glycol)
Nº4:
Induction: 0.3 and 1 % p/v (in water)
Challenge: 1 % p/v (in water) - Route:
- epicutaneous, occlusive
- Concentration / amount:
- Nº1:
Induction: 1 and 3 % p/v (in water)
Challenge: 0.5 % p/v (in water)
Nº2:
Induction: 1 and 3 % p/v (in water)
Challenge: 0.5 % p/v (in water)
Nº3:
Induction: 0.5 and 3 % p/v (in propylene glycol)
Challenge: 0.5 % p/v (in propylene glycol)
Nº4:
Induction: 0.3 and 1 % p/v (in water)
Challenge: 1 % p/v (in water) - No. of animals per dose:
- Treatment: 20 animals
Control: 10 animals - Details on study design:
- RANGE FINDING TESTS:
The concentrations used in the main study were established in a preliminary study to determine the lowest concentrations producing low irritation for the induction phase and the highest non irritant concentrations for the challenge phase.
MAIN STUDY
A. INDUCTION EXPOSURE
Day 1:
Three pairs of intradermal injections of 0.1 ml are given in the shoulder region.
Injection 1: the test substance in an appropriate vehicle at the selected concentration
Injection 2: a 1:1 mixture (v/v) FCA/physiological saline
Injection 3: the test substance at the selected concentration formulated in a 1:1 mixture (v/v) FCA/physiological saline.
Day 8: The substance is applied to the treated area (occlusive) at a slightly irritant concentration for 48 hours.
The control group is treated with the vehicle and FCA following the same conditions as for the treated group.
B. CHALLENGE EXPOSURE
- Day(s) of challenge: Day 22
- Exposure period: 24 h
- Concentrations: 0.5 ml of the test substance at the highest non irritant concentration (occlusive)
- Evaluation (hr after challenge): 24 and 48 h - Positive control substance(s):
- yes
- Remarks:
- (α-hexylcinnamaldehyde (HCA), CAS No. 101-86-0)
- Positive control results:
- The percentage of animals showing a positive response was 31% (6/19).
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 1 and 3 % p/v (in water)
Challenge: 0.5 % p/v (in water) - No. with + reactions:
- 13
- Total no. in group:
- 20
- Remarks on result:
- other: Test group Nº1
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 1 and 3 % p/v (in water)
Challenge: 0.5 % p/v (in water) - No. with + reactions:
- 18
- Total no. in group:
- 20
- Remarks on result:
- other: Test group Nº2
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 0.5 and 3 % p/v (in propylene glycol)
Challenge: 0.5 % p/v (in propylene glycol) - No. with + reactions:
- 12
- Total no. in group:
- 19
- Remarks on result:
- other: Test group Nº3
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 0.3 and 1 % p/v (in water)
Challenge: 1 % p/v (in water) - No. with + reactions:
- 7
- Total no. in group:
- 20
- Remarks on result:
- other: Test group Nº4
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- The percentage of animals showing a positive response after treatment with the test substance was ≥35% in all the test groups. The substance is considered to be a skin sensitiser.
- Executive summary:
A Magnusson and Kligman maximisation test was performed to determine the sensitising potential of the test substance.
The percentage of animals showing a positive response after treatment with the test substance was ≥35% in all the test groups. The substance is considered to be a skin sensitiser.
Reference
The percentage of animals showing a positive response after treatment with the test substance was ≥35% in all the test groups.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Key study: Equivalent to EU method B.6. No data on GLP.
A Magnusson and Kligman maximisation test was performed to determine the sensitising potential of the test substance. The percentage of animals showing a positive response after treatment with the test substance was ≥35% in all the test groups. The substance is considered to be a skin sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data, the substance is classified as Skin sensitiser Category 1A.
Guinea pig maximisation test:
≥ 30 % responding at ≤ 0,1 % intradermal induction dose or
≥ 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose
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.
