Registration Dossier
Registration Dossier
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EC number: 701-196-7 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 1969
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The study meets the EC Standards (conducted equivalent to OECD 405). Non GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 969
- Report date:
- 1969
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no details on test animals and environmental conditions, animals were not observed for irritation 48 hours after exposure: not expected to affect the outcome of the study
- Principles of method if other than guideline:
- Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes", Draize, John H., Woodard, Geoffrey, and Calvery, Herbert O., J. Pharm. & Exp. Ther., 82, 4, December 1944.
- GLP compliance:
- no
- Remarks:
- not present at the time of performance.
Test material
- Reference substance name:
- Reaction products of pentaerythritol, propoxylated and 1-chloro-2,3-epoxypropane with hydrogen sulfide
- EC Number:
- 701-196-7
- Cas Number:
- 72244-98-5
- Molecular formula:
- not applicable
- IUPAC Name:
- Reaction products of pentaerythritol, propoxylated and 1-chloro-2,3-epoxypropane with hydrogen sulfide
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): DION® Polymercaptan Resin DPM 3-800LC
- Description: viscous, amber liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
No data
ENVIRONMENTAL CONDITIONS
No data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye of each animal served as a scoring control.
- Amount / concentration applied:
- TEST MATERIAL
- Amoun applied: 0.1 mL - Duration of treatment / exposure:
- Single instillation on Day 1.
- Observation period (in vivo):
- The eyes of each animal were examined approximately 1 minute, 1, 24 and 72 hours and 7 days after instillation of the test substance.
- Number of animals or in vitro replicates:
- 5
- Details on study design:
- STUDY DESIGN:
The undiluted test material was instilled into the conjunctival sac of the right eye of each test rabbit.
OBSERVATIONS:
The eyes of each animal were examined approximately 1 minute, 1, 24 and 72 hours and 7 days after instillation of the test substance.
SCORING SYSTEM:
The irritation scores and a description of all other (local) effects were recorded.The irritation was assessed according to OECD 405.
Results and discussion
In vitro
Results
- Remarks on result:
- not measured/tested
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1, #2, #3, #4 and #5
- Time point:
- other: 24 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1, #2, #3, #4 and #5
- Time point:
- other: 24 and 72 hrs
- Score:
- 0.5
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hrs.
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- animal #1, #2, #3, #4 and #5
- Time point:
- other: 24 and 72 hrs
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hrs.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Iridal and conjunctival irritation were noted one minute after instillation. Within 72 hours, the ocular tissues had returned to normal.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to Regulation (EC) No 1272/2008
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an eye irritation study with rabbits, performed equivalent to OECD 405 test guideline, slight iridal and conjunctival irritation was observed. Within 72 hours, the ocular tissues had returned to normal.
- Executive summary:
The test substance DPM 3 -800LC was tested in an eye irritation study with rabbits, performed equivalent to OECD 405 test guideline.
Iridal and conjunctival irritation were noted one minute after instillation. Within 72 hours, the ocular tissues had returned to normal.
Based on the results, the substance DPM 3 -800LC does not have to be classified for eye irritation according to Regulation (EC) No 1272/2008.
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