Registration Dossier
Registration Dossier
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EC number: 206-525-3 | CAS number: 352-87-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-05-02 to 1985-06-01
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 12 May 1981
- Deviations:
- yes
- Remarks:
- No pretreatment to create local skin irritation was done before epicutaneous induction.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A valid GPMT conducted comparable to guideline with acceptable restrictions is available, which is reliable with 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.
Test material
- Reference substance name:
- 2,2,2-trifluoroethyl methacrylate
- EC Number:
- 206-525-3
- EC Name:
- 2,2,2-trifluoroethyl methacrylate
- Cas Number:
- 352-87-4
- Molecular formula:
- C6H7F3O2
- IUPAC Name:
- 2,2,2-trifluoroethyl methacrylate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): MATRIFE
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
- Age at study initiation: 8 – 12 weeks
- Weight at study initiation: 420 – 495 g
- Housing: in groups of 4 in solid floor polypropylene cages, furnished with softwood shavings
- Diet (e.g. ad libitum): standard laboratory guinea pig diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%): 45-65%
- Air changes (per hr): approx. 10/h
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- arachis oil
- Concentration / amount:
- intradermal induction: 5% in Arachis oil
topical induction: 100% as supplied
challenge: 100% as supplied
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- intradermal induction: 5% in Arachis oil
topical induction: 100% as supplied
challenge: 100% as supplied
- No. of animals per dose:
- 20 (test group, control group)
- Details on study design:
- RANGE FINDING TESTS:
- intradermal injection of 0.1 mL of 1% and 5% test substance in arachis oil (one guinea pig/concentration)
- observation after 24, 48, 72 h and 7 days for signs of toxicity and necrosis
- topical application of 50% (vehicle: abs. ethanol) and 100% for 24 h (4 guinea pigs, each treated with 50% and 100%)
- observation after patch removal: 1, 24, 48 h for signs of irritation
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal induction
- No. of exposures: 1
- Test groups: test substance
- Control group: vehicle (arachis oil)
- Site: shoulder region, pairwise injections
- Concentrations:
0.1 mL Freund’s complete adjuvant (FCA)
0.1 mL 5% test substance in Arachis oil (or vehicle only in control)
0.1 mL 50:50 mixture of 5% test substance (or vehicle only in control) and FCA
Topical induction
- No. of exposures: 1
- Exposure period: 48 h
- Test groups: 100% test substance
- Control group: vehicle
- Site: shoulder region, same as for intradermal injections
- Frequency of applications: 1
- Duration:
- Concentrations: 100% (or vehicle in control)
- No pretreatment to create local skin irritation was done before epicutaneous induction.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 21
- Exposure period: 24 h
- Test groups: 100% test substance (right), vehicle (left)
- Control group: 100% test substance (right), vehicle (left)
- Site: flanks
- Concentrations: 100%
- Evaluation (hr after challenge): 24 h, 48 h - Positive control substance(s):
- not specified
- Remarks:
- sensitivity of the animals is regularly checked in the laboratory
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Clinical observations:
- reduced body weight gain
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 17.0. Total no. in groups: 20.0. Clinical observations: reduced body weight gain.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Clinical observations:
- reduced body weight gain
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 16.0. Total no. in groups: 20.0. Clinical observations: reduced body weight gain.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No positive reaction.
- 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: 20.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No positive reaction.
- 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: 20.0.
Any other information on results incl. tables
Dose range finding test:
Intradermal application:
- 1 % and 5 %: no evidence of necrosis or systemic toxicity -> 5% is used for the main study
Topical application:
- 100 % (undiluted) and 50%: no irritant response in any animal at any observation -> 100% is used for the main study
Main study:
Induction: no documentation of reactions
Challenge:
- no dermal reactions in the control group
- at the 24 h reading 10/20 animals showed moderate diffuse redness (grade 2), 7/20 animals showed scattered mild redness (grade 1) and 3/20 showed no dermal reaction
- at the 48 h reading 7/20 animals showed moderate diffuse redness (grade 2), 9/20 animals showed scattered mild redness (grade 1) and 4/20 animals showed no dermal reaction
Body weight gains of the test group was slightly reduced between day 0 and 24 compared to the control animals. 3 animals in the experimental group showed body weight losses.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- TFMEA was sensitising in this GPMT test.
- Executive summary:
In a dermal sensitisation study similar to OECD guideline 406, adopted 12 May 1981, with TFMEA (not given in the study report, but according to sponsor >90%), 20 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. For the intradermal and epicutaneous induction procedure concentrations of 5% in arachis oil and 100% were used, respectively. The test article concentration for the challange procedure was 100%. No pretreatment to create local skin irritation was done before epicutaneous induction.
After challenge10/20 animals showed moderate diffuse redness (grade 2), 7/20 animals showed scattered mild redness (grade 1) and 3/20 showed no dermal reaction at the 24 h observation. Similar results were observed after 48 h. No dermal reactions were noted in the control group.
The test material produced a response in 85% of the animals. According to CLP, EU GHS (Regulation (EC) No 1272/2008), a response of at least 30% of the test animals of an adjuvant type guinea pig test method for skin sensitisation is considered as positive.
TFMEA is a dermal sensitiser in this study.
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