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EC number: 940-510-9 | CAS number: 103043-58-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan/MAFF 8147
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- XPB 115
- IUPAC Name:
- XPB 115
- Reference substance name:
- Hexanedioic acid, bis(2-propylheptyl) ester
- IUPAC Name:
- Hexanedioic acid, bis(2-propylheptyl) ester
- Reference substance name:
- 1,6-bis(2-propylheptyl) hexanedioate
- EC Number:
- 940-510-9
- Cas Number:
- 103043-58-9
- Molecular formula:
- C26 H50 O4
- IUPAC Name:
- 1,6-bis(2-propylheptyl) hexanedioate
- Test material form:
- other: liquid
- Details on test material:
- refer to confidential details on test material
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories, Netherlands
- Age at study initiation: Approx. 3 months
- Weight at study initiation: 2.27 kg – 2.51 kg
- Housing: Single housing, Stainless steel wire mesh cages with grating with shallow cage body; floor area: 4225 cm2
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)
IN-LIFE DATES: From: 22 April 2014 To: 09 May 2014
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eyes of same animals used as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): unchanged - Duration of treatment / exposure:
- 24h
- Observation period (in vivo):
- 96h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 24h with warm tap water
- Time after start of exposure: 24h
SCORING SYSTEM: see "any other information on material and methods incl. tables"
TOOL USED TO ASSESS SCORE: hand-slit lamp, otoscope lamp, fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24h - 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24h - 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24h - 72h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Time point:
- other: 24h - 72h
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24h - 72h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24h
Any other information on results incl. tables
No reactions on cornea or iris were observed in any animal during the observation period. Even after installation of fluorescein after 24 and 48 hours no corneal lesions were detectable. Slight conjunctival redness (grade 1) was noted in two animals at 1 hour after application. Slight conjunctival chemosis (grade 1) was noted in one animal at 1 hour after application. Severe discharge (grade 3) was noted in all animals at 1 hour after application. Additional findings like injected scleral vessels in a circumscribed area were noted at hour 1 after application only. The ocular reactions were reversible in all animals within 24 hours after application. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for corneal opacity, 0.0, 0.0 and 0.0 for iris lesions, 0.0, 0.0 and 0.0 for redness of the conjunctiva and 0.0, 0.0 and 0.0 for chemosis.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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