Registration Dossier
Registration Dossier
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EC number: 215-553-5 | CAS number: 1330-86-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 11 - 17 Apr 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- ( adopted 12 May 1981)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Dibutyl adipate
- EC Number:
- 203-350-4
- EC Name:
- Dibutyl adipate
- Cas Number:
- 105-99-7
- Molecular formula:
- C14H26O4
- IUPAC Name:
- dibutyl adipate
- Details on test material:
- - Name of test material: Adipinsäure-di-n-butylester
- Physical state: clear liquid
- Analytical purity: approx. 99.7%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Small White Russian, Chbb‐SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.3 to 2.6 kg (male)
- Housing: Kept individually in stainless steel cages
- Diet: K4 complete feed for rabbits, Ssniff Spezialfutter GmbH, Soest, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 72 h
- Observation period (in vivo):
- 6 days
Reading time points: 1, 24, 48 and 72 h and 6 days - Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The treated eye was rinsed with warm physiological NaCl solution.
- Time after start of exposure: 72 h
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: hand-slit lamp/fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- There were no irritation reactions on the cornea or iris. At the 1 h reading time point there was obvious conjunctival injection (grade 1) in 2/3 animals which, however, completely disappeared after 24 hours.
- Other effects:
- No other effects were noted.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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