Registration Dossier
Registration Dossier
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EC number: 268-952-1 | CAS number: 68155-26-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Read across approach adequate to support 7.3.2 according to "Guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals" (ECHA 2008) and Read-Across Assessment
Framework (RAAF) (ECHA 2017)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Read across approach adequate to support 7.3.2 according to "Guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals" (ECHA 2008) and Read-Across Assessment
Framework (RAAF) (ECHA 2017) - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Species:
- rabbit
- Strain:
- other: albino
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 7 days
- Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- Six albino rabbits received 0.1 ml Linoleamide DEA in one eye, and the untreated contralateral eye was used as the control. Draize scores for irritation were 34 on Day 1, 27 on Day 2, 26 on Day 3, 18 on Day 4, and 13 on Day 7. These scores were the average of the six individual animals’ scores.
- Irritation parameter:
- other: Draize score
- Value:
- 34
- Remarks on result:
- other: day 1
- Remarks:
- average value
- Irritation parameter:
- other: Draize score
- Value:
- 27
- Remarks on result:
- other: day 2
- Remarks:
- average value
- Irritation parameter:
- other: Draize score
- Value:
- 26
- Remarks on result:
- other: day 3
- Remarks:
- average value
- Irritation parameter:
- other: Draize score
- Value:
- 18
- Remarks on result:
- other: day 4
- Remarks:
- average value
- Irritation parameter:
- other: Draize score
- Value:
- 13
- Remarks on result:
- other: day 7
- Remarks:
- average value
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- moderate eye irritant
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Test material
- Reference substance name:
- Reference substance 005
- Cas Number:
- 93-83-4
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 2 days
- Number of animals or in vitro replicates:
- three animals
Results and discussion
In vitro
Results
- Irritation parameter:
- other: congiuntival irritation
- Value:
- 2
- Remarks on result:
- other: max Draize score
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- not irritant to eyes.
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