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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 284-868-8 | CAS number: 84988-79-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 06 - 20 Feb 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study with acceptable restrictions (analytical purity was not specified, lack of methodological details).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- analytical purity of test substance not specified, lack of methodological details
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- analytical purity of test substance not specified, lack of methodological details
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.
Test material
- Reference substance name:
- Reference substance 002
- Cas Number:
- 163961-32-8
- Details on test material:
- - Name of test material: only trade name given
- Physical state: amber colored liquid
- Analytical purity: no data
- Storage condition of test material: RT in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 349 g
- Housing: singly or in pairs in solid floor propylene cages
- Diet: ad libitum, certified guinea pig diet (Code 5026, PMI Nutrition International, UK)
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- arachis oil
- Concentration / amount:
- Intradermal Induction: 1% v/v in arachis oil BP
Topical Induction: undiluted as supplied
Topical Challenge: 75%o and 50% v/v in arachis oil BP
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- Intradermal Induction: 1% v/v in arachis oil BP
Topical Induction: undiluted as supplied
Topical Challenge: 75%o and 50% v/v in arachis oil BP
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS: Yes, treatment concentrations of the main study are based on these results.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: Intradermal induction and epidermal induction
- Test groups: 10 animals, TS
- Control group: animals treated with vehicle
- Concentrations: 1% dilution of the test substance in arachis oil was used for intradermal induction and 100% used for epidermal induction
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Test groups: 10 animals, TS
- Control group: 5, treated analogous to the test groups
- Concentrations: 50% and 75% solution in arachis oil
- Evaluation (hr after challenge): 24 and 48 h - Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde, 2-Mercaptobenzothiazole
Results and discussion
- Positive control results:
- Reliability checks had been performed 2 times a year with 10 test and 5 control animals using alpha-hexylcinnamaldehyde and 2-Mercaptobenzothiazole as positive control substances confirming the sensititvity of the used animal strain.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Any other information on results incl. tables
Challenge readings
Group |
Animal Number |
Skin Reactions (Hours after Removal of Dressings) |
|||||||
24 h |
48 h |
||||||||
50% |
75% |
50% |
75% |
||||||
Er |
Ed |
Er |
Ed |
Er |
Ed |
Er |
Ed |
||
Test Group |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
8 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
9 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
10 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
|
Control Group |
11 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
12 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
13 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
14 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
15 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Ed: Edema
Er: Erythema
Positive controlls were in the range of the historical controls.
No deaths occured. No significant differences in the gain of body weight was observed between treatment and control group.
A transient challenge reaction (discrete erythema) was observed in one animal of the test group at 24 h observation with desquamation at the 48 h observation. The erythema was not apparent at the 48 h observation and therefore not attributed to contact sensitization
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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.
