Registration Dossier
Registration Dossier
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EC number: 205-411-0 | CAS number: 140-31-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not applicable
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: 2e: Meets generally accepted scientific standards, well-documented and acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 958
- Report date:
- 1958
Materials and methods
- Principles of method if other than guideline:
- Conducted prior to guideline
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-piperazin-1-ylethylamine
- EC Number:
- 205-411-0
- EC Name:
- 2-piperazin-1-ylethylamine
- Cas Number:
- 140-31-8
- Molecular formula:
- C6H15N3
- IUPAC Name:
- 2-piperazin-1-ylethanamine
- Details on test material:
- - Name of test material (as cited in study report): beta-Aminoethyl piperazine
- Molecular weight (if other than submission substance):
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Lot/batch No.: D9-1782
- Other: Solution - Greater then 25% water, acetone; 95% ethanol and benzene
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: Two drops
- Concentration (if solution): N/A - Duration of treatment / exposure:
- The right eye is washed (within 30 seconds) for 2 minutes in a flowing stream of tepid water.
- Observation period (in vivo):
- 1 hour; 24 hours; 48 hours; and 7 days
- Number of animals or in vitro replicates:
- Two per dose level
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washed and unwashed
- Time after start of exposure: The right eye is washed (within 30 seconds) for 2 minutes in a flowing stream of tepid water.
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: Immediate
- Score:
- <= 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: LEFT EYE (UNWASHED) RESPONSE - PAIN 4; CONJUNCTIVA 3; CORNEA 2. RIGHT EYE (WASHED) RESPONSE - PAIN 2; CONJUNCTIVA 3; CORNEA 2.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: Immediate
- Score:
- <= 2
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: LFT EYE (UNWASHED)-CONJUNCTIVA(Soft tissue necrotic & swollen) 6 ; CORNEA: BEFORE STAIN 4; AFTER STAIN 4; INTERNAL EFFECTS 3 (IRITIS). RT EYE (WASHED)-CONJUNCTIVA 4; CORNEA: BEFORE STAIN 1; AFTER STAIN 4; INTERNAL EFFECTS 3 (IRITIS)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: After 24 hours
- Score:
- <= 6
- Max. score:
- 6
- Reversibility:
- not specified
- Remarks on result:
- other: LEFT EYE (UNWASHED)-CONJUNCTIVA 6 ; CORNEA: BEFORE STAIN 5; AFTER STAIN 5; INTERNAL EFFECTS No data. RIGHT EYE (WASHED)-CONJUNCTIVA 5; CORNEA: BEFORE STAIN 4; AFTER STAIN 4; INTERNAL EFFECTS 3 (IRITIS)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- <= 4
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: After 48 hours
- Score:
- <= 5
- Max. score:
- 5
- Reversibility:
- not specified
- Remarks on result:
- other: LEFT EYE (UNWASHED)-CONJUNCTIVA 5 ; CORNEA: BEFORE STAIN 5; AFTER STAIN 4; INTERNAL EFFECTS No data. RIGHT EYE (WASHED)-CONJUNCTIVA 5; CORNEA: BEFORE STAIN 4; AFTER STAIN 3; INTERNAL EFFECTS 3 (CLOUDY & IRITIS)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 48 hours
- Score:
- <= 5
- Max. score:
- 5
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: After 7 days
- Score:
- <= 5
- Max. score:
- 5
- Reversibility:
- not specified
- Remarks on result:
- other: LEFT EYE (UNWASHED)-CONJUNCTIVA 5 ; CORNEA: BEFORE STAIN 5; AFTER STAIN 4; INTERNAL EFFECTS 5 (Cloudy). RIGHT EYE (WASHED)-CONJUNCTIVA 5; CORNEA: BEFORE STAIN 4; AFTER STAIN 3; INTERNAL EFFECTS 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 7 days
- Score:
- <= 5
- Max. score:
- 5
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- probability of severe irritation
- Irritant / corrosive response data:
- Extensively irritating to conjunctiva and cornea. Note: The washed eye was slightly less damaged than the unwashed. Iritis was also noted at the 24 hour time point.
- Other effects:
- Permanent blindness produced.
Any other information on results incl. tables
Neat
material: Extensively
irritating to conjunctiva and cornea. Permanent
blindness produced. The
washed eye was slightly less damaged than the unwashed.
10%
solution: Slight
conjunctivitis, essentially subsided in 24 hours.
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information
- Conclusions:
- The undiluted material is severely damaging to the eye. Gross contamination is most likely to result in permanent loss of vision. It is important to emphasize that immediate washing (15 seconds or less) is essential if the degree of damage is to be reduced. Chemical workers goggles should be worn where the likelihood of gross contamination exists.
These conclusions are based upon range finding toxicological tests and are limited to precautions for industrial handling of the material. Development of specific uses will require consideration of the health problems presented and of the need for further toxicological studies. - Executive summary:
Neat material: Extensively irritating to conjunctiva and cornea. Permanent blindness produced. The washed eye was slightly less damaged than the unwashed.
10% solution: Slight conjunctivitis, essentially subsided in 24 hours
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