Registration Dossier
Registration Dossier
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EC number: 247-092-0 | CAS number: 25549-16-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Triisooctylamine
- EC Number:
- 247-092-0
- EC Name:
- Triisooctylamine
- Cas Number:
- 25549-16-0
- Molecular formula:
- C24H51N
- IUPAC Name:
- tris(6-methylheptyl)amine
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.: 0008924462
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. 3-4 months
- Weight at study initiation: 2.63 kg – 3.02 kg
- Housing: Single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Acclimatization for at least 5 days before application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +- 3
- Humidity (%): 30 – 70
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eyes of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 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: after 24 hours of exposure
SCORING SYSTEM: according to OECD 405 guideline
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: no effects on cornea observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: no effects on iris
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects on cornea observed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects on cornea observed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects on cornea observed
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects on iris
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects on iris
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects on iris
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no chemosis
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
Any other information on results incl. tables
Cornea and iris were free of any signs of irritation during the whole observation period.
Slight conjunctival redness (grade 1) was noted in all animals from 1 hour up to hour 72 hours after application and persisted in one animal until study day 7.
Moderate conjunctival chemosis (grade 2) was noted in one animal 1 hour after application. This finding decreased to slight conjunctival chemosis (grade 1) and was noted from hour 24 until study day 7 in this animal. In another animal slight conjunctival chemosis (grade 1) was observed at hour 1 only, while in the third animal this finding was seen from hour 24 until study day 7.
In all animals severe discharge (grade 3) was noticed at hour 1. In one of these animals slight discharge (grade 1) was observed at hour 48.
Additional findings like injected scleral vessels in a circumscribed or circular area were noted in the animals from hour 1 until hour 48 at the latest. Hair loss was seen in two animals from day 7 until day 14 or on day 14, only. Scaling on the eye lids or under the eye was observed in one animal on study day 7, while in another animal this finding was noticed from study day 7 until study day 14. Incrustations on the eye lids or under the eye were observed in one animal on study day 7 and in the two other animals from study day 7 until study day 14. In one of these animals the incrustation, localized under the eye, was pea-sized on study day 7.
The ocular reactions were reversible in one animal within 7 and in two animals within 14 days 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, 1.0, 1.0 and 1.0 for redness of the conjunctiva and 1.0, 0.0 and 1.0 for chemosis.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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