Registration Dossier
Registration Dossier
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EC number: 202-510-0 | CAS number: 96-49-1
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The Murine Local Lymph Node Assay (LLNA) is the first-choice method for in vivo testing according to the REACH Regulation. However, this reliable Buehler test was performed before entry into force of the REACH Regulation.
Test material
- Reference substance name:
- Ethylene carbonate
- EC Number:
- 202-510-0
- EC Name:
- Ethylene carbonate
- Cas Number:
- 96-49-1
- Molecular formula:
- C3H4O3
- IUPAC Name:
- 1,3-dioxolan-2-one
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Ethylene carbonate
- Purity: > 99%
- Physical state: fine crystals
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
- Source: Harlan Winkelmann BmbH, Borchen, Germany
- Age at study initiation: jung adult animals
- Weight at study initiation: < 500g
- Housing: coventional, max 5 animals per cage (Makrolon cage type IV)
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum):ad lib
- Acclimation period: min 5days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22C
- Humidity (%): 30-70%
- Air changes (per hr): 15 changes/h
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 15 Jan 1997 To: 14 Feb 1997 (main experiment)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- pure substance
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- pure substance
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
- 5, 25, 50 and 100%
- 3 animals
- repeat pre-study with 4 weeks older animals (=same age as main study)
- no irritation found = 100% selected for main study
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: d 0, 7, 14
- Test groups: 20 animals
- Control group: 10 animals
- Site: left flank
- Frequency of applications: 1x each
- Duration: 6h
- Concentrations: pue substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1x
- Day(s) of challenge: at day 28
- Exposure period: 6h
- Test groups: 20 animals
- Control group: 10 animals
- Site: right flank, 2x2 cm, 0.3 cm3
- Concentrations: pure substance
- Evaluation (hr after challenge): 30 h and 54 h
OTHER: - Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazol
Results and discussion
- Positive control results:
- - Magnusson Kligman test with 2-MCBT
- 10/10 positive
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- positive control
- Dose level:
- 2-MCBT
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- positive control
- Dose level:
- 2-MCBT
- No. with + reactions:
- 10
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Ethylene carbonate was considered to be a non-sensitizer under the conditions of this test.
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