Registration Dossier
Registration Dossier
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EC number: 295-893-9 | CAS number: 92129-93-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Whey, lactose-low
- EC Number:
- 295-893-9
- EC Name:
- Whey, lactose-low
- Cas Number:
- 92129-93-6
- IUPAC Name:
- Whey, lactose-low
Constituent 1
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- The 0.60 cm² Reconstructed human Cornea-like Epithelia (EpiOcularTM) were equilibrated to room temperature for 15 minutes. Then the inserts (filter + epithelium) were gently removed from the agarose while avoiding leaving agarose on the polycarbonate filter. They were placed in 6 wells culture plate which had been previously filled with 1 mL of 37°C pre-warmed assay medium and incubated during 19 hours and 55 minutes at standard culture conditions.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 50 μL
- Duration of treatment / exposure:
- 30 minutes
- Duration of post- treatment incubation (in vitro):
- 2 hours post-exposure incubation
- Number of animals or in vitro replicates:
- 2 living RhCE tissue replicates
Results and discussion
In vitro
Results
- Irritation parameter:
- other: tissue viability (%)
- Run / experiment:
- mean
- Value:
- ca. 12.9
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- other: UN GHS Category 2 or Category 1.
- Conclusions:
- In accordance with the Regulation EC No. 1272/2008, the test item Whey Lactose-low has to be identified as potentially requiring classification and labeling according to UN GHS Category 2 or Category 1.
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