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Registration Dossier
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EC number: 203-783-9 | CAS number: 110-61-2
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study performed before test guidelines and GLP principles were in place. However missing information and shortcomings in description of the methods. No details on test substance (Lot/Batch number; purity). Exact dosing of test substance not clearly described.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: tests published by the FDA of the United States (Fed. Reg. 28 (119), 5582, 1963)
- Qualifier:
- according to guideline
- Guideline:
- other: Draize and Kelley (Drug Cosmet. Industr, 71 (1952) 36
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- substance was applied 50% diluted, probably due to the fact that the test substance is a waxy substance and could not be applied in the eye as such; it is unclear whether 0.1 ml of succinonitrile or 50% succinonitrile/ 50% water was tested.
- GLP compliance:
- no
- Remarks:
- Study performed before GLP principles were in force
Test material
- Reference substance name:
- Succinonitrile
- EC Number:
- 203-783-9
- EC Name:
- Succinonitrile
- Cas Number:
- 110-61-2
- Molecular formula:
- C4H4N2
- IUPAC Name:
- butanedinitrile
- Details on test material:
- No details given.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Housing: individually housed
Rabbits received no hay or other extraneous material that might enter the eyes
Test system
- Vehicle:
- water
- Remarks:
- 50%
- Controls:
- other: untreated eye serves as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml
- Concentration: 50% - Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- Eyes were examined at 24, 48, 72 hours and 7 days after instillation
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM:
Draize scoring according to current OECD/EC guidelines
TOOL USED TO ASSESS SCORE:
binocular magnifying glass, fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #4
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #5
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #6
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Remarks:
- chemosis
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Remarks:
- chemosis
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Remarks:
- chemosis
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Remarks:
- chemosis
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Irritant / corrosive response data:
- No corrosive effects were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- An eye irritation test similar to the current OECD guideline was performed with rabbits. The substance was applied 50% diluted and gave minor, reversible effects.
Based on these results this substance is not classified for eye irritation. - Executive summary:
An eye irritation test similar to the current OECD guideline was performed with 6 rabbits. The suspension of succinonitrile in water (50%) caused slight redness of the conjunctivae in two out of six rabbits. These effects were reversible within 7 days. Based on these results this substance is not classified for eye irritation.
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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