Registration Dossier
Registration Dossier
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EC number: 209-548-7 | CAS number: 585-07-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Sensitizing potential of 14 mono (meth) acrylates in the guinea pig
- Author:
- Van der Walle HB, Klecak G, Geleick H, Bensink T
- Year:
- 1 982
- Bibliographic source:
- Contact Dermatitis: 8, 223-235
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- No information regarding a reliability check of the test procedure; choice of the vehicle and justification for its usage not given; negative control data are not presented
- Principles of method if other than guideline:
- GPMT according to Magnusson and Kligman 1970
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD. The available data do not justify conducting an additional LLNA due to animal welfare.
Test material
- Reference substance name:
- tert-butyl methacrylate
- EC Number:
- 209-548-7
- EC Name:
- tert-butyl methacrylate
- Cas Number:
- 585-07-9
- Molecular formula:
- C8H14O2
- IUPAC Name:
- tert-butyl 2-methylprop-2-enoate
Constituent 1
- Specific details on test material used for the study:
- - Source: Polyscience Inc., Warrington, USA
- Purity: > 99%
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Himalayan white spotted outbred strain
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Inst. for Biomedical Research, Füllinsdorf, CH
- Weight at study initiation: 350 - 450 g
- Housing: in pairs
- Diet (e.g. ad libitum): pellet diet containing vitamin C
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- peanut oil
- Concentration / amount:
- 0.5 M/ 0.1 mL
- Day(s)/duration:
- day 0/ single injection
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 80 % ethanol
- Concentration / amount:
- 1 M/ 1 mL
- Day(s)/duration:
- day 7-9
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: unclear: pet., peanut oil or Aramek
- Concentration / amount:
- highest non-irritant concentration and 2 lower concentrations (not further specified)/ 0.025 mL
- Day(s)/duration:
- day 21-22
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, open
- Vehicle:
- other: unclear: pet., peanut oil or Aramek
- Concentration / amount:
- highest non-irritant concentration and 2 lower concentrations (not further specified)/ 0.025 mL
- Day(s)/duration:
- day 35
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 (control 6)
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: up to 7 days
- Test groups: 3 pairs of intradermal injections (day 0): 1: FCA alone, 2: test material in vehicle, 3; test material in FCA; epicutaneous application (day 7)
- Control group: These animals received the same treatment without the test material
- Site: shoulder region, the injections with FCA and the test material in vehicle were close to each other and nearest to he head; the injection with FCA and the test material was caudally
- Frequency of applications: 3 injections, 1 epicutaneous application
- Duration: day 0- day 9
- Concentrations: 0.5 M (intradermal), 1 M (epicuateneous)
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: day 21 and day 35
- Exposure period: 24 h (occlusive treatment)
- Test groups: epicutaneous application occlusive and open
- Control group: these animals received the same treatment; in addition the vehicle was tested alone
- Site: right flank (day 21), left flank (day 35)
- Concentrations: highest non-irritant concentration and two lower concentrations (not further specified)
- Evaluation (hr after challenge): 1st and 2nd challenge: 48 and 72 h
other: The maximum non-irritant concentration was determined in a pre-test. The used vehicle was Aramek (oleum arachidis/methylethylketone). Progressively dilutions of the test material were investigated after 24 and 48 h after single open application the clipped flank of 8 animals. - Challenge controls:
- 6 animals
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- not included
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- highest non-irritant concentration and two lower concentrations
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no data
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- highest non-irritant concentration and two lower concentrations
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no data
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- highest non-irritant concentration and two lower concentrations
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no data
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- highest non-irritant concentration and two lower concentrations
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no data
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was not sensitizing under the conditions of the present study in guinea pigs.
- Executive summary:
A publication is available which asesses the potential of the test substance to induce delayed contact hypersensitivity using the guinea pig maximization test (GPMT) based on the method of Magnusson and Kligman in a non-GLP conform study.
The concentrations of the test substance suitable for use in the main experiment were determined in a pretest. The minimum irritant concentration was determined in FCA pretreated animals. The maximum non-irritant concentration also was determined. The used vehicle in the pre-test was Aramek (oleum arachidis/methylethylketone). For the intradermal induction on day 0, 3 pairs of injections were set on the clipped shoulder region. One injection was with FCA alone, the second injection was the test material (0.5 M) in vehicle (peanut oil), the third injection was the test material (0.5 M) in FCA. On day 7, an epicutaneous induction with 1 M test material in the vehicle (80% ethanol) (the concentration giving a slight to moderate irritation) was performed on the same shoulder region. The challenge was performed on day 21 (epicutaneous, occlusive) and day 35 (epicutaneous, open) thereafter. The highest concentration tested was the maximum non-irritating concentration. In addition two lower concentrations and the vehicle were tested. The results were graded according to the classification of Magnusson & Kligman. Both challenges exhibited no positive reactions (0/10 animals).
Based on the results of this study it was concluded that t-butyl methacrylate does not have a sensitizing effect on the skin of the guinea pig in the Maximization Test under the test conditions chosen.
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