Registration Dossier
Registration Dossier
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EC number: 230-811-7 | CAS number: 7328-17-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-03-30 to 1989-04-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed in accordance to GLP and comparable to the OECD 406 guideline, the Guinea pig mazimization test
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- NA
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Data from the in vivo non-LLNA study was already available prior start of present registration
Test material
- Reference substance name:
- 2-(2-ethoxyethoxy)ethyl acrylate
- EC Number:
- 230-811-7
- EC Name:
- 2-(2-ethoxyethoxy)ethyl acrylate
- Cas Number:
- 7328-17-8
- Molecular formula:
- C9H16O4
- IUPAC Name:
- 2-(2-ethoxyethoxy)ethyl acrylate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): EDGA (ethylendiglycolacrylate)
- CAS 7328-17-8
- Physical state: Liquid
- Lot/batch No. EDGA (lot 1010, Fut No: 3282 stabilized in 500 ppm EMHQ
- Storage condition of test material: 4°C
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Dunkin Hartley guinea pigs from Shamrock Bio Service breeding centre (France)
- Age at study initiation: no data
- Weight at study initiation: 347 +/- 19 g (males); 348 +/- 18 g (males)
- Housing: individually housed in sterilized polycarbonate cages
- Diet (e.g. ad libitum): certified pellet diet ad libitum
- Water (e.g. ad libitum): filtered water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): non-recycled and filtered by absolute filters
- Photoperiod (hrs dark / hrs light): 12 hours cycle
IN-LIFE DATES: 23.3.89 - 27.4.89
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- Test substance: 1% in vehicle (Induction)
Test substance: 5% in vehicle (Challenge)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Test substance: 1% in vehicle (Induction)
Test substance: 5% in vehicle (Challenge)
- No. of animals per dose:
- Control group: 5 male/female
Treated group: 10 male/female - Details on study design:
- RANGE FINDING TESTS:
A preliminary test was performed to define dose levels for the main study. Sensitization was performed by intradermal route with 1% test substance in vehicle showing no irritation. Sensitization by cutaneous route was performed with testsubstance in its original form. Challenge application was performed at 5% test substance (maximum non-irritant dose) covered with an occlusive dressing for 24 hours.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 injections. 1: 50% Freund´s adjuvant, 2: Test substance and/or vehicle, 3: Adjuvant mixture + test substance and/or vehicle
- Exposure period: day 1-9
- Test groups: 1: 50% Freund´s adjuvant, 2: Test substance and/or vehicle, 3: Adjuvant mixture + test substance and/or vehicle
- Control group: 1: 50% Freund´s adjuvant, 2: Test substance and/or vehicle, 3: Adjuvant mixture + test substance and/or vehicle
- Site: clipped just before treatment on day 1 and 8 on the scapular area (4 x 2 cm)
- Frequency of applications: 2
- Duration: 10 days
- Concentrations: Injection: 01 ml (1%); Cutaneous: 0.5 ml (100%)
B. CHALLENGE EXPOSURE
- No. of exposures: occlusive dressing for 24 hr on day 26
- Day(s) of challenge: 24 hr
- Exposure period: 24 hr
- Test groups: 0.5 ml of 5% in vehicle (paraffin oil) and 0.5ml of vehicle on each flank
- Control group: 0.5 ml of 5% in vehicle (paraffin oil) and 0.5ml of vehicle on each flank
- Site: site clipped again and shaved on day 25 on each flank (2 x 2 cm)
- Concentrations: 5%
- Evaluation (hr after challenge): 24 and 48hr
OTHER: challenge application made with test substance at 5% = maximum non-irritant dose - Challenge controls:
- yes
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- NA
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% in paraffin oil
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- -
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% in paraffin oil . No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: -.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% in paraffin oil
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- -
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% in paraffin oil. No with. + reactions: 20.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5% in paraffin oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- -
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5% in paraffin oil. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5% in paraffin oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- -
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5% in paraffin oil. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- other: Histopahthological examinations
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% in paraffin oil
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Clinical observations:
- 2 females were considered not to have reacted after histopahtological examination
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Histopahthological examinations. . Hours after challenge: 48.0. Group: test group. Dose level: 5% in paraffin oil. No with. + reactions: 18.0. Total no. in groups: 20.0. Clinical observations: 2 females were considered not to have reacted after histopahtological examination .
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In the Guinea pig mazimization test, the test substance EDGA (EOEOEA) after an intradermal induction dose of 1% in paraffin oil and a challange dose of 5% in paraffin oil induced weak to moderate cutaneous reactions considered a result of a weak to moderate sensitisation reaction in 90% of the guinea pigs. EOEOEA should according to the CLP criteria be classified as Skin Sens 1A.
- Executive summary:
In the Guinea pig mazimization test, the test substance EDGA (EOEOEA) after an intradermal induction dose of 1% in paraffin oil and a challange dose of 5% in paraffin oil induced weak to moderate cutaneous reactions (considered a result of a weak to moderate sensitisation reaction) in 90% of the guinea pigs. Due to the high rate of positive reactions (90% of the animals) EOEOEA should according to the CLP criteria be classified as Skin Sens 1A.
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