Registration Dossier
Registration Dossier
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EC number: 614-925-8 | CAS number: 69098-08-4
Skin sensitisation
Administrative data
- 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: Guideline study conducted in accordance with GLP; low purity of the test substance (71.2 %)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
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 3-methoxy-3-(4-methoxyphenyl)propanoate
- EC Number:
- 614-925-8
- Cas Number:
- 69098-08-4
- Molecular formula:
- C12 H16 O4
- IUPAC Name:
- methyl 3-methoxy-3-(4-methoxyphenyl)propanoate
- Details on test material:
- - Name of test material (as cited in study report): 3-(4-Methoxyphenyl)-3-methoxypropionsaueremethylester, technical grade
- Substance No.: 93/98
- Batch No.: Ansatz 165
- Purity: 71.2 %.
- Date of manufacturing: 22 Apr 1993
- Physical state: solid, brown; after heating at about30 °C: liquid brown
- Storage condition of test material: REFRIGERATOR, EXCLUSION OF LIGHT AND AIR (UNDER NITROGEN), EXCLUSION OF MOISTURE
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
- Strain: Pirbright White, Dunkin Hartley
- Sex: female
- Source: Charles River GmbH - Wiga, Sulzfeld, FRG
- Age of the animals: young adults
- Weight at study initiation: 315 - 376 g
- Housing: 5 animals per cage in Makrolon type IV cages
- Diet: ad libitum, Kliba Labordiät 341 Kaninchen-Meerschweinchen-Haltungsdiät
- Water: ad libitum, tap water; about 2 g of ascorbic acid per 10 l water was added to the drinking water twice a week
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- olive oil
- Concentration / amount:
- 1st application: Intradermal induction with 5 % test substance in olive oil DAB 10 resp. in Freund's adjuvant/0.9 % aqueous NaCl-solution (1:1) resp. olive oil DAB 10
2nd application: Percutaneous induction with undiluted test substance
3rd application: Challenge with undiluted test substance (epicutaneous)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- 1st application: Intradermal induction with 5 % test substance in olive oil DAB 10 resp. in Freund's adjuvant/0.9 % aqueous NaCl-solution (1:1) resp. olive oil DAB 10
2nd application: Percutaneous induction with undiluted test substance
3rd application: Challenge with undiluted test substance (epicutaneous)
- No. of animals per dose:
- 20 per test group
10 per control group - Details on study design:
- RANGE FINDING TEST:
- Exposure period: The test substance was applied undiluted 2 times for 24 hours (epicutaneous, occlusive) within a period of 96 hours.
- Site of application: flank, respective on the same area
- Number of test animals: 3 per test concentration
- Readings: about 24 and 48 h after the beginning of application
MAIN STUDY
A. INDUCTION EXPOSURE
- Three pairs of intradermal injection (Freund´s adjuvant, test substance with vehicle, test substance with Freund´s adjuvant and vehicle) and one week later one percutaneous induction according to OECD 406; the control animals were given the same injections without test substance. Since the percutaneous induction was applied unchanged to the test animals (no solvent used), the control group was left untreated during the percutaneous induction.
- Readings 24 hours after the intradermal injection and 48 hours after the percutaneous application.
- Site of application: shoulder, same area for intradermal injection and percutaneous application
B. CHALLENGE EXPOSURE
- Epicutaneous challenge was carried out 21 days after the intradermal injection according to OECD 406
- Site of application: intact flank
- Readings: 24 and 48 hours after removal of the patch - Challenge controls:
- No application, since the test substance was applied unchanged to the test group animals and thus no solvent was used.
- Positive control substance(s):
- yes
- Remarks:
- A separate study was performed in the laboratory (run during October/November 1993); Test substance was 1-chloro-2,4-dinitrobenzene.
Results and discussion
- Positive control results:
- 1-chloro-2,4-dinitrobenzene has a sensitizing effect on the skin of the guinea pig strain used (Pirbright White, Dunkin Hartley) in the Maximization Test.
The 1st challenge (24 hours after removal of the test patch) with the 0.5 % test substance preparation in ethanol conc. caused well-defined erythema in 8 out of 20 test group animals. 4 out of these animals additionally showed scaling and 1 very slight edema. Very slight erythema was observed in 7 out of 20 test group animals. One out of these animals additionally exhibited scaling. The animals of control group 1 did not show any skin
reactions.
After the 2nd challenge (24 hours after removal of the test patch) with the 0.5 % test substance preparation in ethanol conc. 2 out of 20 test group animals showed well-defined erythema. In 17 out of 20 test group animals very slight erythema could be observed. 5 out of 10 animals of control group 1 exhibited very slight erythema.
The animals of control group 2 did not show any skin reaction. Ethanol conc. applied as a vehicle did not cause any skin reactions in all animals after both challenges.
1st challenge 2nd challenge
0.5 % test substance ethanol 0.5 % test substance ethanol
in ethanol conc. conc. in ethanol conc. conc.
Control group 1 0/10 0/10 5/10 0/10
Control group 2 no application of TS 0/10 0/10 0/10
Test group 15/10 0/20 19/20 0/20
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- 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: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- undiluted
- 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: undiluted. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Pretest
In the preliminary test after two 24 -hour percutaneous occlusive applications of the unchanged test substance within 96 hours no skin reaction could be observed (48 hours after the beginning of application).
Main test
After the intradermal induction well-defined erythema and slight edema could be observed at the injection sites of the control group animals and test group animals at which only Freunds adjuvant/0.9 % aqueous NaCl-solution (1:1) was applied. Injection of the test substance preparation in olive oil DAB 10 resp. in Freund's adjuvant/0.9 % aqueous NaCl-solution (1:1) caused well-defined erythema and slight edema in the test group animals. The control group animals injected with olive oil DAB 10 (vehicle) showed well defined erythema.
Since the test substance was applied unchanged and no solvent was used, the percutaneous induction was only carried out in the test group. Incrustation, partially open (caused by the intradermal induction) in addition to well-defined erythema and slight edema were observed.
The challenge (24 and 48 hours after removal of the patch) with the unchanged test substance did not cause any skin reactions neither in the test group animals nor in the control animals.
Applicant's summary and conclusion
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