Registration Dossier
Registration Dossier
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EC number: 440-850-3 | CAS number: 27311-52-0
Eye irritation
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: According to the OECD Guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: EC-Guideline 93/21
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [TN]Ro 1525[/TN][SPEC][/SPEC][AM]99 %[/AM]
- IUPAC Name:
- [TN]Ro 1525[/TN][SPEC][/SPEC][AM]99 %[/AM]
- Reference substance name:
- -
- EC Number:
- 440-850-3
- EC Name:
- -
- Cas Number:
- 27311-52-0
- Molecular formula:
- C13H14N2O2.2ClH
- IUPAC Name:
- 4-amino-2-[(5-amino-2-hydroxyphenyl)methyl]phenol dihydrochloride
- Details on test material:
- Ro 1525 corresponds to Colipa A 155
Ro1525
Batch No.: Ro-Rn 6567-083.
SAT 980375
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- undiluted
, moistened
Amount applied: 0.1 ml - Duration of treatment / exposure:
- 24 hour(s)
- Observation period (in vivo):
- 72 hour(s)
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Comment: not rinsed
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable, no irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable, no irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable, no irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable, no irritation
- Irritation parameter:
- other: conjunctivae, redness
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- other: conjunctivae, redness
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- other: conjunctivae, redness
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- other: conjunctivae, chemosis
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- other: conjunctivae, chemosis
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- other: conjunctivae, chemosis
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible
Any other information on results incl. tables
Mean Scores for redness and chemosis of the conjunctivae exceed the thresholds for classifying
a test substance as "irritating" as set by the EC Guideline 9312 1. Criteria for corrosion are not
fulfilled.
Therefore the test substance "Ro1525" is an irritant according to the EC-guideline 93/21.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Classification: irritating
The following mean scores were calculated for each animal from the individual examinations
performed 24 h, 48 h and 72 h p.a.:
Cornea: 0, 1, 0
Iris: 0, 0.33, 0
Conjunctivae, redness: 2, 3, 2.67
Conjunctivae, chemosis: 2.33, 4, 2.67
Ocular lesions were reversible in all animals. A noteworthy high interindividual variation in the
response to the test substance was present.
Mean scores for redness and chemosis of the conjunctivae exceed the thresholds for classifying
a test substance as "irritating" as set by the EC Guideline 93/21. Criteria for corrosion are not
fulfilled.
Therefore the test substance "Ro1525" is an irritant according to the EC-guideline 93/21. - Executive summary:
Aim of the study
The aim of this study was to investigate possible irritating or corrosive effects of the undiluted
test substance following a single administration into a conjunctival sac of rabbits.
Methods
Methods and investigations were performed in conformance with the following guidelines:
OECD Guideline 405, 1987.
EC Guideline 92/69, method B.5.
EC Guideline 9312 1 (classification).
ECETOC Document No. 37, 1997.
Administration of the test substance
The equivalent of 0.1 ml "Ro1525" was instilled into the conjunctival sac of one eye of each of
3 rabbits. The eyes were rinsed with warm water after 24 h.
Investigations
Body weight: at the Start and at the conclusion of the test.
General signs: once daily.
Eye examination: 1, 24,48, 72 h and 6,8, 10, 13, 15, 17,21, 26 d after the administration
(p.a.) of the test substance (ending individually, when the animal was free of alterations).
Results
General signs
No other than ocular lesions were noted.
Eye examination
Cornea: 2 animals were normal at any time. In one animal diffuse opacity of the cornea was
present from 48 h to 21 d p.a., this cornea was normal again 26 d p.a.
Iris: 2 animals were normal at any time. In one animal mild lesions were observed from 72 h
to 17 d p.a.
Conjunctivae, redness: Pronounced redness was observed in all animals already 1 h p.a.
Redness decreased slowly, and had vanished in the last animal21 d p.a.
Conjunctivae, chemosis: An obvious to a severe swelling was Seen in all animals already
1 h p.a. The severity of the swelling diminished with time and 15 d p.a. chemosis had
returned to normal in the last animal.
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