Registration Dossier
Registration Dossier
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EC number: 939-549-4 | 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Experimental Toxicology and Ecology, BASF Aktiengesellschaft, 67056 Ludwigshafen/Rhein, Germany
Test material
- Reference substance name:
- Reaction mass of 1-Hexanol, 2-ethyl-, reaction products with 1,6-diisocyanatohexane and Hexane, 1,6-diisocyanato-, homopolymer
- EC Number:
- 939-549-4
- Molecular formula:
- Unspecified
- IUPAC Name:
- Reaction mass of 1-Hexanol, 2-ethyl-, reaction products with 1,6-diisocyanatohexane and Hexane, 1,6-diisocyanato-, homopolymer
- Test material form:
- other: Liquid
- Details on test material:
- - Physical state / appearance: Liquid / clear, colorless - yellowish
- Homogeneity: The test substance was homogeneous by visual inspection.
- Stability: The stability under storage conditions over the exposure period was guaranteed by the sponsor
- Storage conditions: Room temperature, exclusion of oxygen (stored under nitrogen)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: About 6 - 7 months
- Weight at study initiation: 3.52 - 3.82 kg
- Housing: Single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm²
- Diet: Kliba-Labordiät, Provimi Kuba SA, Kaiseraugst, Switzerland (about 130 g/animal per day)
- Water: Tap water ad libitum
- Acclimation period: At least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Negative control: Untreated left eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1mL. The test substance was applied in a single dose to the conjunctival sac of the right eyelid. - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 1 female, 2 males
- Details on study design:
- - Body weight determination: Just before application of the test substance and after the last reading.
- Route of application: The test substance 0.1 mL (undiluted) was applied in a single dose to the conjunctival sac of the right eyelid.
- Rinsing of the eye: About 24 hours after application of the liquid test substance the treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water tor 1 to 2 minutes using a syringe with a blunt probe.
- Readings: Approx. 1, 24, 48 and 72 h after application.
- Illumination used tor reading: Daylight tubes ‹Lumilux" (L 58W/860 PLUS ECO 25X1, Osram, Germany)
- Check for dead or moribund Twice each workday (beginning and end) and once animais: on Saturdays, Sundays and on public holidays.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 - 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 - 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 - 24 hours
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48 - 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- other: Conjunctiva: Discharge
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- other: Conjunctiva: Discharge
- Basis:
- mean
- Time point:
- other: 24 hour
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- other: Conjunctiva: Discharge
- Basis:
- mean
- Time point:
- other: 48 - 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritant / corrosive response data:
- - Slight conjunctival redness (grade 1) was observed in one animal 1 hour after application up to 24 hours. Two animals showed moderate conjunctival redness (grade 2) from 1 hour until 48 hours after application. Slight conjunctival chemosis (grade 1) was noted in one animal 24 hours after application only. Slight discharge (grade 1) was observed in two animals 1 hour after application. Severe discharge (grade 3), noted in one animal after 1 hour, decreased to slight at the 24 hour-reading.
- No other ocular reactions were observed during the study.
- The ocular reactions were reversible in one animal within 48 hours and in two animals within 72 hours after application.
- Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0 for corneal opacity and for iris lesions, 0.3, 1.3 and 1.3 for redness of the conjunctiva and 0.0, 0.3 and 0.0 for chemosis.
Applicant's summary and conclusion
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