Registration Dossier
Registration Dossier
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EC number: 605-047-6 | CAS number: 156157-97-0
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:
- other: GLP-study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
- Principles of method if other than guideline:
- Test method according to ICCVAM Test Method Evaluation Report: Appendix G - ICCVAM recommended HET-CAM Method Protocol (2006)
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- The pure active substance was used.
Purity: 99%
Batch number: Catena-08-183
Production date: 16.05.2008
Expiry date: 05.2009
Storage: Closed vessel at room temperature in the dark
Test animals / tissue source
- Species:
- other: not applicable, as in vitro test was used
- Details on test animals or tissues and environmental conditions:
- not applicable
Test system
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- approximately 100 mg
- Observation period (in vivo):
- 300 seconds
- Number of animals or in vitro replicates:
- not applicable
- Details on study design:
- Freshly laid Lohmann selected Leghorn chicken eggs obtained on 28.07.08 were used for the HET-CAM test.
24h before start of the experiment 8-days old eggs were candled and non-viable eggs were discarded.
Endpoints measured were the time of appearance (of effects) for
- haemorrhage
- vascular lysis
- coagulation
Results and discussion
In vivo
Results
- Irritation parameter:
- other: mean irritation score
- Basis:
- other: HET-CAM
- Time point:
- other: not applicable
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- An mean irritation score (MIS) of 17.69 was calculated according to the above indicated recommended test method protocol.
Irritation score (IS) is calculated as
IS= (301 – time until haemorrhage)/300*5+
(301 – time until lysis)/300*7+
(301 – time until coagulation)/300*9
The MIS is the mean over repeated measurements.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The substance has to be considered as a severe eye irritant and has to be labelled accordingly.
- Executive summary:
Following the recommended ICCVAM HET-CAM test protocol, the test substance showed a mean irritation score of 17.69 and has to be considered as a severe eye irritant.
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