Registration Dossier
Registration Dossier
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EC number: 208-816-0 | CAS number: 542-52-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- other: summary report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
- Principles of method if other than guideline:
- HET-CAM
- GLP compliance:
- no
Test material
- Reference substance name:
- Dibutyl carbonate
- EC Number:
- 208-816-0
- EC Name:
- Dibutyl carbonate
- Cas Number:
- 542-52-9
- Molecular formula:
- C9H18O3
- IUPAC Name:
- dibutyl carbonate
- Reference substance name:
- Butyl carbamate
- EC Number:
- 209-751-0
- EC Name:
- Butyl carbamate
- Cas Number:
- 592-35-8
- Molecular formula:
- C5H11NO2
- IUPAC Name:
- butyl carbamate
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: B323
- Purity test date: July 4, 2001
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
OTHER SPECIFICS: Colorless liquid
Test animals / tissue source
- Species:
- chicken
Test system
- Vehicle:
- other: undiluted or as 10% solution in olive oil
- Controls:
- yes, concurrent positive control
- Amount / concentration applied:
- undiluted or as 10% solution in olive oil
- Duration of treatment / exposure:
- up to 301 seconds
- Number of animals or in vitro replicates:
- 3 per test substance concentration
2 per positive control substance
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: irritation index
- Run / experiment:
- unidluted
- Value:
- 12.1
- Positive controls validity:
- valid
- Irritation parameter:
- other: irritation index
- Run / experiment:
- 10% solution
- Value:
- 0
- Positive controls validity:
- valid
- Irritation parameter:
- other: irritation index
- Run / experiment:
- positive control
- Value:
- >= 11.9 - <= 12.5
Any other information on results incl. tables
| Time (seconds) until appearance of | Irritation index | ||||
| Haemorrhagia | Lysis | Coagulation | |||
| undiluted | 1 | 62 | 301 | 26 | 12.2 |
| 2 | 67 | 301 | 38 | 11.8 | |
| 3 | 38 | 301 | 33 | 12.4 | |
| Mean | 55.7 | 301 | 32.3 | 12.1 | |
| 10% | 1 | 301 | 301 | 301 | 0 |
| 2 | 301 | 301 | 301 | 0 | |
| 3 | 301 | 301 | 301 | 0 | |
| Mean | 301 | 301 | 301 | 0 | |
| NaOH | Mean | 19.5 | 301 | 41 | 12.5 |
| SDS | Mean | 33.5 | 301 | 52.5 | 11.9 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Risk of serious eye damage
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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