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Registration Dossier
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EC number: 938-148-1 | CAS number: 375-45-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 January 2003 to 19 June 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- Version / remarks:
- (1987)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- (1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- (1998)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,2,3,4-tetrachloro-1,1,2,3,4,4-hexafluorobutane
- EC Number:
- 938-148-1
- Cas Number:
- 375-45-1
- Molecular formula:
- C4Cl4F6
- IUPAC Name:
- 1,2,3,4-tetrachloro-1,1,2,3,4,4-hexafluorobutane
- Details on test material:
- - Name of test material (as cited in study report): A1112 Dimer
- Substance type: pure substance
- Physical state: liquid
- Analytical purity: 99%
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: 99% pure substance
- Isomers composition: not applicable
- Purity test date: not reported
- Lot/batch No.: DAD 619
- Expiration date of the lot/batch: 2005
- Storage condition of test material: ambient temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd, Margate, Kent, UK
- Age at study initiation: no data (young adults), 3 females
- Weight at study initiation: 2236 - 3022 g
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): minimum 15 ACH
- Photoperiod (hrs dark / hrs light): 12 h light, 12 hrs dark
IN-LIFE DATES: From: 29-JAN-2003 To: 14-FEB-2003
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- The test substance (0.1 ml) was instillated once, on day 1.
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 1 day
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 1.2 hour
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 1.2 hour
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: 1 hour
- Score:
- 1.3
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24 h
- Score:
- 0.7
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 110
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 110
Any other information on results incl. tables
There were no signs of ill-health in any naimal during the study. Instillation into the eye caused practically no initial pain (class 1 on a 0 -5 scale). There were no corneal or iridial effects. Conjunctival effects consisted of slight redness in two animals for up to 1 day and slight chemosis in one animal approximately 1 hour after instillation only. There were no additional signs of irritation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 1,2,3,4-tetrachloro-hexafluorobutane is not an eye irritant.
- Executive summary:
The purpose of the study was to assess the eye irritation potential of 1,2,3,4-tetrachloro-hexafluorobutanet o rabbits.
The study was conducted in accordance with guidelines OECD 405 (1987), EU method B.5 (1992) and EPA OPPTS 870.2400 (1998).
A volume of 0.1 ml of 1,2,3,4-tetrachloro-hexafluorobutane was instilled into one eye of each of three rabbits and an assessment of initial pain was made.
The eyes were examined for 3 days, to assess the grade of ocular reaction.
There were no signs of ill-health in any animal during the study. Instillation into the eye caused practically no initial pain (class 1 on a 0 -5 scale). There were no corneal or iridial effects. Conjunctival effects consisted of slight redness in two animals clearing within 24 hours and slight chemosis in one animal approximately 1 hour after instillation only. There were no additional signs of irritation.
1,2,3,4-tetrachloro-hexafluorobutane is not classified as an eye irritant according to GHS criteria.
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