Registration Dossier
Registration Dossier
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EC number: 806-451-7 | CAS number: 42532-60-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2012
- Deviations:
- no
- Remarks:
- No deviations occurred that negatively impacted the integrity of the study.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,3,3,3-tetrafluoro-2-(trifluoromethyl)propanenitrile
- EC Number:
- 806-451-7
- Cas Number:
- 42532-60-5
- Molecular formula:
- C4 F7 N
- IUPAC Name:
- 2,3,3,3-tetrafluoro-2-(trifluoromethyl)propanenitrile
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3M Company, Lot LA-M000-2160-9
- Expiration date of the lot/batch: 05 April, 2022
- Purity test date: 16 January, 2015
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature (19-3-22.8 C)
FORM AS APPLIED IN THE TEST: Gas
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kitayama Labs
- Age at study initiation: 11 weeks old
- Weight at study initiation: 1924-2085 g
- Housing: Individually
- Diet (e.g. ad libitum): Pellet (RC4 Oriental Yeast Co.) ad libitum
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.9-23.8
- Humidity (%): 45.5-75.1
- Air changes (per hr): 10-20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 16 May, 2017 To: 27 May, 2017
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A single 1 second burst of the gaseous substance (0.7-0.8 g of the test article)
VEHICLE: None - Duration of treatment / exposure:
- A single 1 second burst of the gaseous substance (0.7-0.8 g of the test article)
- Observation period (in vivo):
- 72 hours
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There were no observations of corneal opacity, iritis, or conjunctival redness or chemosis; mean (24, 48, and 72 hours) cornea, iris, conjunctival redness and chemosis scores for the three animals were 0. PII = 0/110.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- There were no observations of corneal opacity, iritis, or conjunctival redness or chemosis; mean (24, 48, and 72 hours) cornea, iris, conjunctival redness and chemosis scores for the three animals were 0. PII = 0/110. Not irritating per GHS.
- Executive summary:
The eye irritation potential of MTDID 28136 was evaluated in New Zealand White Rabbits. The study was conducted according to OECD 405 (2012) in compliance with OECD GLP. MTDID 28136 (gas) was applied undiluted by single 1 second burst (0.7-0.8 g test material) to 3 male rabbits from a distance of 10cm directly into the right eye; left eye served as control. No severe eye impairment was observed at 1 hour after application. There were no observations of corneal opacity, iritis, or conjunctival redness or chemosis; mean (24, 48, and 72 hours) cornea, iris, conjunctival redness and chemosis scores for the three animals were 0. PII = 0/110. Not irritating per GHS.
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