Registration Dossier
Registration Dossier
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EC number: 600-775-0 | CAS number: 1067676-04-3
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:
- guideline study with acceptable restrictions
- Justification for type of information:
- Guideline study, 2018, to GLP
Commercial grade material tested with ca 50% in water and solvents ethandiol and butanol
Not considered possible to isolate from water and solvents; the substance is stabilised by the presence of water under alkaline conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Phenol, 4,4'-(1-methylethylidene)bis-, oligomer with (chloromethyl)oxirane and ethylenediamine, reaction products with carbon disulphide, potassium salts
- EC Number:
- 600-775-0
- Cas Number:
- 1067676-04-3
- IUPAC Name:
- Phenol, 4,4'-(1-methylethylidene)bis-, oligomer with (chloromethyl)oxirane and ethylenediamine, reaction products with carbon disulphide, potassium salts
- Test material form:
- liquid
- Details on test material:
- Technical grade, CA 50% in water
Constituent 1
- Specific details on test material used for the study:
- Commercial grade material tested with ca 50% in water and solvents ethandiol and butanol
Not considered possible to isolate from water and solvents; the substance is stabilised by the presence of water under alkaline conditions
Test animals / tissue source
- Species:
- cattle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 0.75 ml
- Duration of treatment / exposure:
- 10 minutes exposure
Results and discussion
In vitro
Results
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 1
- Value:
- 77.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- No other observations
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Severe response, greater than the threshold for classification.
Study validation criteria were met.
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