Registration Dossier
Registration Dossier
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EC number: 500-017-8 | CAS number: 9005-00-9 1 - 2.5 moles ethoxylated
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:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 963
- Report date:
- 1963
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2020
- Deviations:
- yes
- Remarks:
- please refer to "Principles of method if other than guideline" for details.
- Principles of method if other than guideline:
- Deviations to OECD guideline 405 (2020): 6 animals/sex used, no systemic analgesics and topical anaesthetics given, no stepwise testing, no information on animals or environmental conditions, limited reporting on procedure and results; conjunctival reactions not discriminated for redness and chemosis (only one value reported), 60% formulation used
- GLP compliance:
- no
- Remarks:
- Prior to implementation of GLP.
Test material
- Reference substance name:
- 9005-00-9 (purity 60%)
- IUPAC Name:
- 9005-00-9 (purity 60%)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.4 - 2.1 kg
Test system
- Vehicle:
- water
- Remarks:
- 60% formulation
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 72 h
- Observation period (in vivo):
- 14 days. However only data for 6 days were available.
Reading time points: 1, 24, 48, 72 and 96 h and 7, 10 and 14 days - Number of animals or in vitro replicates:
- 9 (6 male and 3 female)
6 animals (3 male and 3 female): no washing; 3 animals (3 male): eyes were rinsed after test item instillation - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washing was perfomed in 6/9 animals using 20 mL of water at body temperature
- Time after start of exposure: 2 seconds after test item instillation
SCORING SYSTEM: Draize scoring
TOOL USED TO ASSESS SCORE: not specified
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: Only unwashed animals were regarded for calculation.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: Only unwashed animals were regarded for calculation.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: Only unwashed animals were regarded for calculation. Score represents a worst case, since individual scores for conjunctivae and chemosis are not given.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Only unwashed animals were regarded for calculation. Score represents a worst case, since individual scores for conjunctivae and chemosis are not given.
- Irritant / corrosive response data:
- The test item showed irritation in 3/6 unwashed eyes 24 h after instillation. In the remaining animals, no irritation was observed for any animal at any reading time point.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- The test substance, applied at a concentration of 60% in water, did not induce eye irritation in an in vivo study similar to OECD guideline 405.
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