Registration Dossier
Registration Dossier
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EC number: 605-637-3 | CAS number: 172529-93-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06.01.1993 - 13.03.1993
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,3-dimethyl 2-[2-(2-amino-6-chloro-9H-purin-9-yl)ethyl]propanedioate
- Cas Number:
- 172529-93-0
- Molecular formula:
- C12 H14 Cl N5 O4
- IUPAC Name:
- 1,3-dimethyl 2-[2-(2-amino-6-chloro-9H-purin-9-yl)ethyl]propanedioate
- Reference substance name:
- Amino-6-chloro-9-(methyl-2-carbomethoxybutanoate-4-yl)purine
- IUPAC Name:
- Amino-6-chloro-9-(methyl-2-carbomethoxybutanoate-4-yl)purine
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- 55 MG
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- The animals were observed for up to 14 days.
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 2
- Irritation parameter:
- chemosis score
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Irritation parameter:
- cornea opacity score
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Irritation parameter:
- iris score
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 14 days
- Other effects:
- Dulling of the cornea in 2 animals 1 hour after start of
exposure.
Vascularisation of the cornea: 2 rabbits on day 7.
Ectropion - eyelids partially overted and pocess a convoluted appearance: 1 rabbit on days 3 and 7.
Discharge: observed in the 3 rabbits from 1 hour to 3 days after dosing.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- according to the OECD-Guideline 405 and the REGULATION (EC) No 1272/2008., the test material is regarded as a irritating to eyes.
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