Registration Dossier
Registration Dossier
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EC number: 700-978-5 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well reported study, no information about housing
- Justification for type of information:
- Justification for not submitting the in vitro study.
The new legal requirements (21 June 2016) require an in vitro eye irritation study. However the previous data requirements were met with an in vivo study during dossier compilation for the >1000 t/y tonnage band. Therefore there is no need to repeat the study using an alternative test method.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FDA-Richtlinien (Federal Register, Vol. 38, No. 187, 1973)
- Principles of method if other than guideline:
- 0.1 ml of the product has been applied in the conjunctival sac of the rabbits eye and observations has been done untill after 72 hours.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- trisodium 2-(2-sulfonatoethoxy)ethane-1-sulfonate ethenesulfonate
- EC Number:
- 700-978-5
- Molecular formula:
- C2H3O3S.Na C4H8O7S2Na2
- IUPAC Name:
- trisodium 2-(2-sulfonatoethoxy)ethane-1-sulfonate ethenesulfonate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- SPF-Albino-Himalayan-Kaninchen
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: 2nd eye serves as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with NaCl solution
- Time after start of exposure: after 24h
SCORING SYSTEM: FDA-Richtlinien Klassifizierung
TOOL USED TO ASSESS SCORE: magnifying glass / slit lamp / fluorescein
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 0.08
- Max. score:
- 8
- Reversibility:
- fully reversible
- Remarks on result:
- other: Score 0.0 - 0.5 considered not irritating
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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