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EC number: 944-290-5 | CAS number: -
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:
- 2014-09-01 to 2014-09-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- October 2, 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- May 30, 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- August 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nousan No. 8147; November 24, 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bioassay-Labor für biologische Analytik GmbH, Im Neuenheimer Feld 515-519, 69120 Heidelberg, Germany
Test material
- Reference substance name:
- Reaction product of Propanoic acid, 3-[[bis(2-methylpropoxy)phosphinothioyl]thio]-2-methyl- and tridecanamine, N-tridecyl-, branched and linear
- EC Number:
- 944-290-5
- Molecular formula:
- C38H80NO4PS2 (idealized)
- IUPAC Name:
- Reaction product of Propanoic acid, 3-[[bis(2-methylpropoxy)phosphinothioyl]thio]-2-methyl- and tridecanamine, N-tridecyl-, branched and linear
- Test material form:
- liquid: viscous
1
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 and Charles River Wiga GmbH, Germany
- Age at study initiation: Approx. 3 - 5 months
- Weight at study initiation: 2.53 kg – 4.36 kg
- Housing: individually
- Diet: ad libitum (STANRAB (P) SQC; SDS Special Diets Services, 67122 Altrip, Germany)
- Water: tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: adjacent eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: treated eyes were rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe
- Time after start of exposure: 24 hours
SCORING SYSTEM: The evaluation of eye irritation was performed according to the quoted guidelines.
Cornea opacity:
Degree of density (the most dense area is taken for reading)
0 No ulceration or opacity
1 Slight: Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 Moderate: easily discernible translucent area, details of iris slightly obscured
3 Marked: nacreous area, no details of iris visible, size of pupil barely discernible
4 Severe: opaque cornea, iris not discernible through the opacity
Iris:
0 Normal
1 Moderate: markedly deepened congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these observations or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 Severe: no reaction to light, haemorrhage, gross destruction (any or all of these)
Conjunctivae redness: (Refers to palpebral and bulbar conjunctivae, not to cornea and iris)
0 Blood vessels normal
1 Slight: some blood vessels definitely hyperemic (injected)
2 Obvious: diffuse, crimson color, individual vessels not easily discernible
3 Severe: diffuse beefy red
Chemosis:
Lids and/or nictitating membrane
0 No swelling
1 Slight: any swelling above normal (includes nictitating membranes)
2 Moderate: obvious swelling with partial eversion of lids
3 Marked: swelling with lids about half closed
4 Severe: swelling with lids more than half closed
TOOL USED TO ASSESS SCORE: Hand slit lamp, fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritant / corrosive response data:
- Slight conjunctival redness (grade 1) was noted in all animals from 1 hour up to 24 hours after application and persisted in one of these animals until hour 72. Slight conjunctival chemosis (grade 1) was noted in all animals 1 hour after application and persisted in one animal until hour 24. Slight discharge (grade 1) was noted in two animals 1 hour after application, while in the third animal obvious discharge (grade 2) was observed at the same reading time point. In all animals circular injected scleral vessels were noticed at hour 1. In two of these animals injected scleral vessels in a circumscribed area were noted from hour 24 until hour 48. The ocular reactions were reversible in two animals within 48 hours and in one animal within 7 days after application.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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