Registration Dossier
Registration Dossier
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EC number: 500-035-6 | CAS number: 25214-63-5 (>1 <8.5 mol PO)
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 1a Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ethylenediamine, propoxylated
- EC Number:
- 500-035-6
- EC Name:
- Ethylenediamine, propoxylated
- Cas Number:
- 25214-63-5
- Molecular formula:
- (C3H6O)n (C3H60)n (C3H6O)n(C3H6O)n C2H8N2 sum of n: >1 - 8.5
- IUPAC Name:
- Ethylenediamine, propoxylated
- Details on test material:
- Name: Ethylenediamine, propoxylated mw 360 (NLP)
Color: brownish
Purity: not reported
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS: rabbit
- Strain: himalayan
- Sex: males
- Source: Leuschner & Co., Löhndorf, Germany
- Age: approx. 5 months
- Weight at study initiation: 2200 - 2400 g
- Number of animals: 3
- Controls: untreated eye served as control
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- unspecified
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Preparation of test substance: Undiluted
- Amount of substance instilled: 0.1 ml
- Vehicle: None
- Postexposure period: 7 days
EXAMINATIONS
- Ophthalmoscopic examination: Yes
- Scoring system: Draize
- Observation period: 1, 24, 48, 72 hours and 4, 7 days post-instillation
- 24 hours and 7 days after administration the eyes were treated additionally with fluorescein and examined.
- Tool used to assess score: Standard ophthalmoscope
Comment: not rinsed
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 DAYS
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: iris (severely) reduced in size
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: iris (severely) reduced in size
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: iris (severely) reduced in size
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 18 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hrs
- Irritant / corrosive response data:
- AVERAGE SCORE (24+48+72 hour)
- Cornea: 1
- Iris: 1
- Conjuntivae (Redness): 0.6
- Conjuntivae (Chemosis): 0.6
DESCRIPTION OF LESIONS:
Cornea1 opacity (grade 1) was observed in all three animals at the examination time points one hour to 5 days after instillation, in animal no. 3 until 6 days after instillation. All animals showed an irritation of the iris (grade 2) one hour after instillation, and an irritation (grade 1) 24 to 5 days in all animals, in animal no. 3 up to 6 days after instillation. Conjunctival redness of grade 1 was observed in all animals 1 to 24 hours after instillation, in animal no. 1 up to 5 days after instillation. Conjunctival chemosis (grade 1) was observed in all animals 1 to 24 hours after instillation, in animal no. 1 up to 72 hours after instillation. The fluorescein test performed after 24 hours revealed corneal staining in animal nos. 1 and 3 (1/2 of the corneal surface) and in animal no. 2 (1/4 of the corneal surface).
REVERSIBILITY: day 7 all scores at 0 - Other effects:
- There were no systemic intolerance reactions.
Any other information on results incl. tables
AVERAGE SCORE (24+48+72 hour)
- Cornea: 1
- Iris: 1
- Conjuntivae (Redness): 0.6
- Conjuntivae (Chemosis): 0.6
DESCRIPTION OF LESIONS:
Cornea1 opacity (grade 1) was observed in all three animals at the examination
time points one hour to 5 days after instillation, in animal no. 3 until 6
days after instillation. All animals showed an irritation of the iris
(grade 2) one hour after instillation, and an irritation (grade 1) 24 to 5
days in all animals, in animal no. 3 up to 6 days after instillation.
Conjunctival redness of grade 1 was observed in all animals 1 to 24 hours
after instillation, in animal no. 1 up to 5 days after instillation.
Conjunctival chemosis (grade 1) was observed in all animals 1 to 24 hours
after instillation, in animal no. 1 up to 72 hours after instillation. The
fluorescein test performed after 24 hours revealed corneal staining in
animal nos. 1 and 3 (1/2 of the corneal surface) and in animal no. 2 (1/4
of the corneal surface).
REVERSIBILITY: day 7 all scores at 0
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the present test conditions, ethylenediamine, propoxylated was classified as irritating to eyes.
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