Registration Dossier
Registration Dossier
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EC number: 432-500-3 | CAS number: -
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29-02-2000 to 30-03-2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to international guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): Ceraphyl RMT
- Date received: 19 February 2000
- Description: yellow liquid
- Storage condition of test material: room temperature
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Ace animals, Boyertown, PA on 22/2/2000
- Quarantine period of at least six days.
- Age at study initiation: 2 to 3 weeks
- Weight at study initiation: males: 235-322 g
- Fasting period before study: not applied
- Housing: 1/cage
- Diet (e.g. ad libitum): Fresh Purina Rat Chow (Diet #5025)
- Water (e.g. ad libitum): Tap water
- Acclimation period: 1 to 3 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: safflower oil
- Concentration / amount:
- 1. 100% Ceraphyl RMT
2. 5% Ceraphyl RMT in safflower oil
3. 100% Safflower oil
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: safflower oil
- Concentration / amount:
- 1. 100% Ceraphyl RMT
2. 5% Ceraphyl RMT in safflower oil
3. 100% Safflower oil
- No. of animals per dose:
- 25
- Details on study design:
- 20 animals per group were tested in the induction and challenging phases, while 5 animals per group were only challenged to serve as a naive control.The site reserved for induction was only clipped in ten animals, while it was abraded in the other ten animals. A volume of 0.4 ml of test substance, mixture of test substance with safflower or safflower only was applied for induction using a 25 mm Hilltop Chamber, which was covered and wrapped to provide full occlusion. Exposure lasted for 6 hours. This procedure was repeated two times with a period of one week between each of the exposures resulting in 3 x 6-h exposures on the same area of skin. Forteen days after the last induction the challenge was performed with the same procedure but using another site on the skin. A significant reaction/incidence = Erythema score ≥ 1.
- Challenge controls:
- Yes, naive controls of treated animals and vehicle controls.
- Positive control substance(s):
- yes
- Remarks:
- Sensitivity of the guina pigs to dinitrochlorobenzene (DNCB) performed every half year.
Results and discussion
- Positive control results:
- 24h: incidence was 0.50 and severity was 0.78
48h: incidence was 0.30 and severity was 0.58
Conclusion: DNCB is a sensitizer
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% abraded
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100% abraded. No with. + reactions: 5.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% clipped only
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100% clipped only. No with. + reactions: 6.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% abraded
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% abraded. No with. + reactions: 3.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% clipped only
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% clipped only. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- clipped only
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: clipped only. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% abraded
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100% abraded. No with. + reactions: 6.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% clipped only
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100% clipped only. No with. + reactions: 4.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% abraded
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% abraded. No with. + reactions: 5.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% clipped only
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% clipped only. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- abraded
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: abraded. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- clipped only
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: clipped only. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Erthema incidences in the Ceraphyl RMT (RMT) treated groups:
| 100% RMT | 24 | 48 | 5% RMT | 24 | 48 |
| ma1 | 1 | 1 | ma1 | 2 | 2 |
| ma2 | 0 | 0 | ma2 | 1 | 1 |
| ma3 | 1 | 0.5 | ma3 | 1 | 1 |
| ma4 | 0.5 | 0 | ma4 | 0.5 | 1 |
| ma5 | 0 | 0 | ma5 | 0.5 | 0 |
| ma6 | 2 | 1 | ma6 | 0 | 1 |
| ma7 | 1 | 1 | ma7 | 0 | 0.5 |
| ma8 | 0 | 0 | ma8 | 0.5 | 0 |
| ma9 | 2 | 2 | ma9 | 0 | 0 |
| ma10 | 0 | 0 | ma10 | 0 | 0 |
| Severity | 0.75 | 0.55 | Severity | 0.55 | 0.65 |
| Incidence | 0.50 | 0.40 | Incidence | 0.30 | 0.50 |
| 100% RMT | 24 | 48 | 5% RMT | 24 | 48 |
| m-1 | 1 | 1 | m-1 | 0 | 0 |
| m-2 | 0.5 | 0.5 | m-2 | 0.5 | 0 |
| m-3 | 0 | 0 | m-3 | 0 | 0.5 |
| m-4 | 1 | 1 | m-4 | 0 | 0 |
| m-5 | 0.5 | 0 | m-5 | 0 | 0 |
| m-6 | 2 | 2 | m-6 | 0.5 | 0.5 |
| m-7 | 1 | 1 | m-7 | 0 | 0 |
| m-8 | 0.5 | 0.5 | m-8 | 0 | 0 |
| m-9 | 1 | 1 | m-9 | + | + |
| m-10 | 2 | 1 | m-10 | 1 | 1 |
| Severity | 0.95 | 0.80 | Severity | 0.22 | 0.22 |
| Incidence | 0.60 | 0.60 | Incidence | 0.10 | 0.10 |
| ma = abraded | |||||
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information sub-category 1B Criteria used for interpretation of results: EU
- Conclusions:
- Ceraphyl RMT is not classified as sub-category 1A ensitizer because no significant incidences (erythema score ≥ 1) were ≥ 60 % at 5% (= between 0,2 % to 20 %) topical induction dose. Ceraphyl RMT meets the criteria for classification as sub-category 1B sensitizer because incidences (erythema score ≥ 1) were between 15 and 60 % for 5 % topical induction on abraded skin and > 15 % at 100 % topical 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.
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