Registration Dossier
Registration Dossier
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EC number: 249-636-2 | CAS number: 29450-45-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08.08.2008 - 15.08.2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-ethylhexyl (4-chloro-2-methylphenoxy)acetate
- EC Number:
- 249-636-2
- EC Name:
- 2-ethylhexyl (4-chloro-2-methylphenoxy)acetate
- Cas Number:
- 29450-45-1
- Molecular formula:
- C17H25ClO3
- IUPAC Name:
- 2-ethylhexyl (4-chloro-2-methylphenoxy)acetate
- Reference substance name:
- (4-chloro-2-methylphenoxy)acetic acid
- EC Number:
- 202-360-6
- EC Name:
- (4-chloro-2-methylphenoxy)acetic acid
- Cas Number:
- 94-74-6
- Molecular formula:
- C9H9ClO3
- IUPAC Name:
- (4-chloro-2-methylphenoxy)acetic acid
- Test material form:
- liquid
Constituent 1
impurity 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks:
- 1 score after 1 hour for redness
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks:
- 1 score after 1 hour for rednees
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks:
- 1 score after 1 and 24 hours for redness
- Irritation parameter:
- chemosis score
- Remarks:
- swelling
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Remarks:
- swelling
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Remarks:
- swelling
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
Results of eye irritation/corrosion
After administration of test item, pathological changes in conjunctiva of rabbits’ eyes were stated. No pathological changes were stated in cornea and iris. During reading after 1 hour since administration of test item, the following changes were stated in conjunctiva of eye in all rabbits: erythema in form of congestion (injection) of some blood vessels, congestion of nictating membrane and circumcorneal injection. Furthermore, excretion on lids and lids’ hair was observed in rabbits No 1 and 2 whereas slight volumes of excretion were observed in rabbit No 3. During reading after 24 hours since administration of test item, erythema in form of congestion (injection) of some blood vessels and congestion of nictating membrane were observed in rabbit No 3. No pathological changes were stated in rabbits No 1 and 2. During reading after 48 and 72 hours since administration of test item, no pathological changes were stated in none of rabbits.
Body weight of animals
At the start of experiment the rabbit No 1 weighed 3.0 kg, rabbit No 2 – 2.9 kg and rabbit No 3 – 2.8 kg. At the end of experiment rabbit No 1 weighed 3.1 kg, rabbit No 2 – 2.9 kg and rabbit No 3 – 2.8 kg.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Taking into account the obtained results, one may state that MCPA-2EH active substance does not irritate eyes.
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