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Registration Dossier
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EC number: 619-642-3 | CAS number: 106-78-5
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28.08.2000-08-28 to 2000-09-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1992
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-{2-[(2-chloroacetyl)oxy]ethoxy}ethyl 2-chloroacetate
- Cas Number:
- 106-78-5
- Molecular formula:
- C8H12O5Cl2
- IUPAC Name:
- 2-{2-[(2-chloroacetyl)oxy]ethoxy}ethyl 2-chloroacetate
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: LPT
- Age at study initiation: approx. 7.5 month
- Weight at study initiation: 2.7 - 2.8 kg
- Housing: For 8 hours following test substance application, the animals were kept singly in special restrainers which allowed free movement of the head but prevented a complete body turn and wiping of the eyes. During the acclimatisation period and after the 8-hour period in restrainers, the rabbits were kept separately in cages with dimensions of 425 mm x 600 mm x 380 mm
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 50% ± 20%
- Photoperiod (hrs dark / hrs light): 12 hours / 12 hours
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- 0.1 ml/animal (right eye) - Duration of treatment / exposure:
- 1 day
- Observation period (in vivo):
- 6 days
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM:
CORNEA
Opacity: degree of density (area most dense taken for reading)
0 = no ulceration or opacity
1 = scattered or diffuse areas of opacity (other than slight dulling of normal lustre). details of iris clearly visible
2 = easily discernible translucent area, details of iris slightly obscured
3 = nacreous areas, no details of iris visible, size of pupil barely discernible
4 = Opaque cornea, iris not discernible through the opacity
IRIS
0 = normal
1 = markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 = no reaction to light, haemorrhage, gross destruction (any or all of these)
CONJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)
0 = blood vessels normal
1 = some blood vessels definitely hyperaemic (injected)
2 = diffuse, crimson colour, individual vessels not easily discernible
3 = diffuse beefy red
Chemosis: lids and/or nictitating membrane
0 = no swelling
1 = any swelling above normal (including nictitating membranes)
2 = obvious swelling with partial eversion of lids
3 = swelling with lids about half-closed
4 = swelling with lids more than half-closed
TOOL USED TO ASSESS SCORE: slit lamp / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: animal #1 and animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: animal #1, animal #2 and animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: animal #1, animal #2 and animal #3
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: animal #1, animal #2 and animal #3
- Time point:
- other: 6 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: animal #1, animal #2 and animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: animal #1, animal #2 and animal #3
- Time point:
- other: 6 d
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: animal #1, animal #2 and animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: animal #1, animal #2 and animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: animal #1 and animal #3
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: animal #1, animal #2 and animal #3
- Time point:
- other: 6 d
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal: animal #1 and animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal: animal #1 and animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: animal #1, animal #2 and animal #3
- Time point:
- other: 6 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- 24 hrs fluorescein test:
animal nos. 1 and 2: corneal staining 1/2 of the surface)
animal no. 3: corneal staining (whole surface)
Any other information on results incl. tables
There were no systemic intolerance reactions.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Irritating to eyes
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