Registration Dossier
Registration Dossier
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EC number: 202-510-0 | CAS number: 96-49-1
Endpoint summary
Administrative data
Description of key information
Skin sensitisation:
Only one reliable study, performed according to OECD guideline 406, was
available (Klimisch 2) which reported that ethylene carbonate is not
sensitising to the skin.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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.
- 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) - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- pure substance
- 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
- Positive control results:
- - Magnusson Kligman test with 2-MCBT
- 10/10 positive - 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
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Ethylene carbonate was considered to be a non-sensitizer under the conditions of this test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation:
Huels (1997) studied skin sensitisation in a buehler test, performed according to OECD guideline 406, with guinea pigs (Dunkin-Hartley strain). Ethylene carbonate was not sensitising to the skin under the conditions of the test.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the available data and the criteria of the CLP Regulation, ethylene carbonate should not be classified as a skin sensitiser. No data are available to decide on the classification for respiratory sensitisation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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