Registration Dossier
Registration Dossier
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EC number: 230-241-9 | CAS number: 6976-93-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991-10-28 to 1994-11-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 31 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 17 July 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A valid GPMT conducted according to guideline is available, which is reliable without restrictions and adequate for classification and labelling purposes. Potency estimation is not mandatory when existing guideline and GLP conforming data are available, which were conducted before the new annex of the REACH Regulation entered into force. Moreover, no indication for skin sensitisation was observed in this study, thus, no dose response information is needed. For this reason and for reasons of animal welfare no additional LLNA was conducted.
Test material
- Reference substance name:
- 2-ethoxyethyl methacrylate
- EC Number:
- 219-135-3
- EC Name:
- 2-ethoxyethyl methacrylate
- Cas Number:
- 2370-63-0
- Molecular formula:
- C8H14O3
- IUPAC Name:
- 2-ethoxyethyl methacrylate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 2-ethoxyethyl methacrylate, MAEE
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 353±23 g
- Housing: individually in polycarbonate cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2
- Humidity (%): 30-70
- Air changes (per hr): app. 12
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- intadermal induction: 10% in paraffin oil
epicutaneous induction: 100%
challenge: 100%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- intadermal induction: 10% in paraffin oil
epicutaneous induction: 100%
challenge: 100%
- No. of animals per dose:
- 10 (test group), 5 (control group)
- Details on study design:
- RANGE FINDING TESTS:
determination of the minimal irritant concentration which did not provoke necrosis or ulceration by intradermal route: 10%
application by cutaneous route: 100% did not induce local irritation
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal induction
- No. of exposures: 1
- Test groups: test substance, 10% in paraffin oil
- Control group: vehicle
- Site: shoulder region
- Frequency of applications: 1x
- Concentrations:
0.1 mL Freund’s complete adjuvant (FCA)
0.1 mL 10% test substance (or vehicle only in control)
0.1 mL 50:50 mixture of 10% test substance (or vehicle only in control) and FCA
Epicutaneous induction on day 8
- No. of exposures: 1
- Exposure period: 48 h
- Test groups: 100% test substance
- Control group: vehicle
- Site: shoulder region, same as for intradermal injections
- Concentrations: 100% test substance (or vehicle in control)
- pretreatment with 10% sodium laurylsulphate in Vaseline to provoke local skin irritation one day before epicutaneous induction
B. CHALLENGE EXPOSURE on day 22
- No. of exposures: 1
- Day(s) of challenge: day 22
- Exposure period: 24 h
- Test groups: 100% test substance (right), vehicle (left)
- Control group: 100% test substance (right), vehicle (left)
- Site: posterior flanks
- Concentrations: 100%
- Evaluation (hr after challenge): 24 h, 48 h - Challenge controls:
- yes, vehicle
- Positive control substance(s):
- yes
- Remarks:
- DINITRO 2,4 CHLOROBENZENE
Results and discussion
- Positive control results:
- The positive control substance Dinitro-2,4-chlorobenzene (performed January 1994) induced positive skin sensitisation reactions in 100% of the guinea-pigs at a concentration of 0.5%.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.5% left flank, 0.1% right flank
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.5% left flank, 0.1% right flank
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
No clinical signs or mortalities were observed during the study. The body weight gain of the treated animals was normal when compared to that of the control animals.
At the end of the induction period, on day 10, after removal of the dressing, signs of irritation were observed at the intradermal injection sites in control and treated groups.
No cutaneous reactions were observed 24 and 48 hours after removal of the dressing of the challenge cutaneous application of the test substance.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- ETMA is not a dermal sensitiser in this study.
- Executive summary:
In a dermal sensitisation study according to OECD guideline 406, adopted 17 July 1992, and EU method B.6, 31 July 1992, with ETMA (99.94% a.i.), 10 young adult female Dunkin-Hartley guinea pigs were tested using the method of Magnusson & Kligman (Guinea Pig Maximisation Test).
Test concentrations were selected based on pretest results: 10% in paraffin oil was the minimal irritant concentration which did not provoke necrosis or ulceration by intradermal route. 100% was used for topical induction as well as for challenge. As the test substance was not irritating, the skin was preteated with 10% sodium laurylsulphate in Vaseline to provoke local skin irritation prior to epicutaneous induction.
At the end of the induction period, on day 10, after removal of the dressing, signs of irritation were observed at the intradermal injection sites in control and treated groups.
No cutaneous reactions were observed 24 and 48 hours after removal of the dressing of the challenge cutaneous application of the test substance.
The positive control substance Dinitro-2,4-chlorobenzene induced positive skin sensitisation reactions in 100% of the guinea-pigs at a concentration of 0.5%.
ETMA is not a dermal sensitiser in this study.
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