Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 294-955-2 | CAS number: 91771-62-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Cyperus scariosus, Cyperaceae.
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- The Draize eye test Reference Database (DRD)
- Author:
- João Barroso et.al
- Year:
- 2 017
- Bibliographic source:
- Archives of toxicology,2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize test
- Principles of method if other than guideline:
- To assess the ocular irritation potential of test chemical in rabbits according to Draize method
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Camphene
- EC Number:
- 201-234-8
- EC Name:
- Camphene
- Cas Number:
- 79-92-5
- Molecular formula:
- C10H16
- IUPAC Name:
- Camphene
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report):Camphene- Molecular formula :C10H16- Molecular weight :136.236 g/mol- Substance type:Organic- Physical state:solid- Purity: 95%- Obtained from – Sigma Aldrich
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- Undiluted
- Duration of treatment / exposure:
- single
- Observation period (in vivo):
- 21 days
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize methodMean scores are calculated for each animal from gradings at 24, 48, and 72 h after instillation of the test chemical and these “severity scores” are then used to determine the classification of the test chemical
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 7 d
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Conjunctival redness or chemosis was observed in 3 of 3 rabbits
Any other information on results incl. tables
Table: Draize eye test reference database
Physical state | Purity | Commercial source | UN GHS category | Number of animals | Comments |
Solid | >95% | Sigma –Aldrich | Cat2B | 3/3 | - |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- Conjunctival redness or chemosis was observed in 3 of 3 rabbits. Based on these observations, the test chemical was considered to be irritating to rabbit eyes, was classified under the category “Category 2B”.
- Executive summary:
An eye irritation study in rabbits was conducted to assess the irritation potential of the test chemical. The study was performed according to Draize method. Undiluted test chemical was instilled in the eyes of 3 rabbits and observed for signs of irritation till 7 days. The reactions observed were scored according to Draize method.Mean scores are calculated for each animal from gradings at 24, 48, and 72 h after instillation of the test chemical and these “severity scores” are then used to determine the classification of the test chemical.
Conjunctival redness or chemosis was observed in 3 of 3 rabbits. Based on these observations, the test chemical was considered to be irritating to rabbit eyes, was classified under the category “Category 2B”.
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