Registration Dossier
Registration Dossier
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EC number: 500-097-4 | CAS number: 37353-75-6 1 - 4.5 moles propoxylated
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4,4'-Isopropylidenediphenol, propoxylated
- EC Number:
- 500-097-4
- EC Name:
- 4,4'-Isopropylidenediphenol, propoxylated
- Cas Number:
- 37353-75-6
- Molecular formula:
- The substance is a UVCB and contains a series of homologues that have the general molecular formula C15H16O2.(C3H6O)n, where 2 ≤ n ≤ 10 (average degree of propoxylation: => 1 ; < 4.5 )
- IUPAC Name:
- 4,4-'isopropylidene, propoxylated (1 - 4.5 moles propoxylated)
- Test material form:
- liquid: viscous
Constituent 1
Test animals / tissue source
- Species:
- other: bovine
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 60 minutes
- Number of animals or in vitro replicates:
- No number given, multiple corneas used.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- -1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Results of control test
| Opacity +/- SD | Permeability +/- SD | In Vitro Irritancy Score |
Irritant Classification | |
| Positive Control | 245 +/- 7.371 | 2.118 +/- 0.111 | 276.8 +/- 7.6 | Corrosive/Severe |
| Negative Control | 2.333 +/- 2.309 | 0. 009 +/- 0.001 | N/A | N/A |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Irritant classification non corrosive/non severe
- Executive summary:
Further animal testing is not considered appropriate.
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