Registration Dossier
Registration Dossier
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EC number: 905-983-8 | CAS number: -
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: guideline study and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
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:
- Benzyl 2-ethylhexyl adipate
- EC Number:
- 261-234-9
- EC Name:
- Benzyl 2-ethylhexyl adipate
- Cas Number:
- 58394-64-2
- Molecular formula:
- C21H32O4
- IUPAC Name:
- benzyl 2-ethylhexyl adipate
- Reference substance name:
- Bis(2-ethylhexyl) adipate
- EC Number:
- 203-090-1
- EC Name:
- Bis(2-ethylhexyl) adipate
- Cas Number:
- 103-23-1
- Molecular formula:
- C22H42O4
- IUPAC Name:
- bis(2-ethylhexyl) adipate
- Reference substance name:
- Dibenzyl adipate
- EC Number:
- 219-516-4
- EC Name:
- Dibenzyl adipate
- Cas Number:
- 2451-84-5
- Molecular formula:
- C20H22O4
- IUPAC Name:
- dibenzyl adipate
- Test material form:
- liquid
Constituent 1
Constituent 2
1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.1 - 3.3 kg
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The opposite untreated eye served as control.
- Amount / concentration applied:
- 100 µl
- Duration of treatment / exposure:
- once
- Observation period (in vivo):
- up to 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- 100 µl test compound was instilled into the conjunctival sac of one eye of each of three rabbits after gently pulling the lowere lid away from the eyeball. The lids were then gently held together for avout one second. The other eye remained untreated and served as control. The treated eye was washed out tith physiological saline 24 hours after the instillation of the test compound . The animals were observed for 21 days.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: score = o at any time point
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Irritant / corrosive response data:
- The 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' can be regarded as not irritating to the eye.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
A study for irritant / corrosive potential on the rabbit's eye was conducted with 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' in accordance with the OECD Guideline for testing of chemicals No. 405.
Based on the obtained results 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' can be regarded as not irritating to the eye.
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