Registration Dossier
Registration Dossier
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EC number: 424-590-8 | CAS number: 98298-66-9 CARBONATE DE CHLORO-1-ETHYLE ET ISOPROPYLE
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test was carried out according to OECD test guideline 406 in compliance with GLP. Data entered as supplied by ECHA following an inquiry for the same substance.
Data source
Reference
- Reference Type:
- other: study summary provided by ECHA
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EU B6 - OECD 406
- GLP compliance:
- yes
- Type of study:
- not specified
Test material
- Reference substance name:
- Chloro-1-ethyl isopropyl carbonate
- EC Number:
- 424-590-8
- EC Name:
- Chloro-1-ethyl isopropyl carbonate
- Cas Number:
- 98298-66-9
- Molecular formula:
- C6H11ClO3
- IUPAC Name:
- 1-chloroethyl propan-2-yl carbonate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction:
Day 1: Intradermal injection of 5% test substance in paraffin
Day 8: Epicutaneous application of pure substance (100%)
Challenge:
Day 22: Epicutaneous application of 75% test substance in paraffin
Challengeopen allclose all
- Route:
- other: epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction:
Day 1: Intradermal injection of 5% test substance in paraffin
Day 8: Epicutaneous application of pure substance (100%)
Challenge:
Day 22: Epicutaneous application of 75% test substance in paraffin
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75%. No with. + reactions: 20.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75%. No with. + reactions: 20.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75%. No with. + reactions: 6.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 75%
Signs of irritation during induction: Skin reactions in 100% of the animals tested.
Skin reactions that were more intense than the maximum reaction observed in control animals at 48 hours were considered as sensitising reactions (19/20 animals).
The score was 1 in the control animals.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results of this study demonstrate that the substance is classified as a skin sensitiser (Skin Sensitiser, Category 1B) according to EU classification requirements (CLP).
- Executive summary:
All animals experienced skin effects at a concentration level of 75% of the test substance, therefore the substance is classified as a skin sensitiser (Skin Sensitiser, Category 1B) according to EU classification requirements (CLP). The results indicate that the
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