Registration Dossier
Registration Dossier
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EC number: 604-351-6 | CAS number: 143390-89-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP / OECD Guideline study (406)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- methyl (2E)-2-methoxyimino-2-[2-[(2-methylphenoxy)methyl]phenyl]acetate
- EC Number:
- 604-351-6
- Cas Number:
- 143390-89-0
- Molecular formula:
- C18 H19 N O4
- IUPAC Name:
- methyl (2E)-2-methoxyimino-2-[2-[(2-methylphenoxy)methyl]phenyl]acetate
- Details on test material:
- - Name of test material (as cited in study report): Reg. No. 242 009 (test substance number: 91/180-2)
- Lot/batch No.: N 36 (= III C1); date of manufacturing: 1991-10-23
- Storage condition of test material: room temperature, exclusion of light
- Physical state: solid (powder) / light brown
- Analytical purity: 93.7% (Reversed-Phase - HPLC with UV-Detection)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, hagemann GmbH & Co. KG, D-W4923 Extertal, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 283 - 341g
- Housing: Makrolon, type IV; Bedding: Granulat Typ 3/4
- Diet (e.g. ad libitum): Kliba Labordiaet 341, Klingentalmuehle AG, Kaiseraugust, Switzerland; ad libitum
- Water (e.g. ad libitum): tap water; ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): no data (fully air conditioned room)
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 0.5% Tylose CB 30000 in 0.9% aqueous NaCl solution or in aqua bidest.
- Concentration / amount:
- induction: intradermal 5%; epicutanous 50%
challenge: 50% (in 0.5% Tylose CB 30000 aqua bidest.)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 0.5% Tylose CB 30000 in 0.9% aqueous NaCl solution or in aqua bidest.
- Concentration / amount:
- induction: intradermal 5%; epicutanous 50%
challenge: 50% (in 0.5% Tylose CB 30000 aqua bidest.)
- No. of animals per dose:
- 10 per control group (two control groups)
20 in the test group - Details on study design:
- Pretest:
2 x 2 cm filter paper strips containing the test substance formulation were applied to the skin of the flanks under an occlusive dressing. Test sites were visually evaluated 24 h and 48 h after application of test solutions. In accordance with the OECD Guideline 406 a slightly irritating concentration should be used in the main test for induction whereas the maximum non-irritant concentration should be applied for challenge.
Main study
- Intradermal induction:
Intradermal induction using adjuvant technique has been recommended to enhance immune response so that weak sensitizing compounds can be detected. 6 intradermal injections were conducted (on groups of two per animal). Skin readings were performed 24 h after application. Site of application: Shoulder.
- Percutaneous induction:
Percutaneous induction was carried out one week after intradermal induction. 2 x 4 cm filter paper strips containing the test substance formulation were applied to the skin of the shoulder for 48 h under an occlusive dressing. The filter paper strip was soaked in the test substance formualtion. This way the animals were exposed to about 0.3g of the test substance formulation. The control groups were treated analogously to the test group but only with the solvent without the test substance. Skin readings were performed 48 h after application.
- Challenge:
Fourteen days after percutaneous induction, 2 x 2 cm filter paper strips containing the test substance formulation were applied to the skin of the flank for 24 h under an occlusive dressing (non-irritant concentration). The filter paper strip was soaked in the test substance formulation. Skin reactions were read at 24 and 48 after the removal of the patch.
Evaluation:
The number of animals with skin findings at 24 hours after the removal of the patch was taken into account for the determination of the sensitization rate. The evaluation "sensitizing" results if at least 30 per cent of the test animals exhibit skin reactions. Assessment of skin findings according to Draize, J.H. (1959). - Challenge controls:
- A positive control (reliability check) with a known sensitiser is not included in this study, however, a separate study will be performed twice a year in the laboratory. The latest control was performed with 1-chlor-2,4-dinitro-benzol and gave a 100% response of all (20) animals tested.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control group 1
- Dose level:
- 50% test substance
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group 1. Dose level: 50% test substance. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control group 1
- Dose level:
- vehicle only
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group 1. Dose level: vehicle only. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control group 2
- Dose level:
- vehicle only
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group 2. Dose level: vehicle only. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% test substance. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- vehicle only
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: vehicle only. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
|
Challenge |
|
|
test substance 50% in 0.5% Tylose CB 30.000 in aqua bidest. |
0.5% Tylose CB 30.000 in aqua bidest. |
Control group 1 |
0 / 10 |
0 / 10 |
Control group 2 |
no application of test substance |
0 / 10 |
Test group |
0 / 20 |
0 / 20 |
Table 1: Results
x/y: number of positive reactions / number of animals tested; reading 24 h after removal of the patch.
Control group 2 that had been intended for a potential 2nd challenge was not treated with the test substance since a 2nd challenge was not necessary on basis of the unambiguous results of the 1st challenge.
Applicant's summary and conclusion
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