Registration Dossier
Registration Dossier
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EC number: 253-462-2 | CAS number: 37321-62-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 Nov 1998 - 29 Jan 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 1987
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2017
- Deviations:
- yes
- Remarks:
- no rationale for in vivo testing
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1992 - 1993
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dodecanoic acid, ester with 1,2-propanediol
- EC Number:
- 253-462-2
- EC Name:
- Dodecanoic acid, ester with 1,2-propanediol
- Cas Number:
- 37321-62-3
- Molecular formula:
- C15H30O3 C27H52O4
- IUPAC Name:
- Dodecanoic acid, ester with 1,2-propanediol
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- NZW I.N.R.A. A9077 (known bacteriological and viral status)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: E.S.D. (Romans, 01400 Chatillon-sur-Chalaronne, France)
- Age at study initiation: about 3 months old
- Weight at study initiation: 2.35 - 2.98 kg
- Gender: male
- Housing: individually in stainless steel cages (50x60x40 cm)
- Diet (e.g. ad libitum): Pelleted complete rabbit diet, about 150 g/animal/day
- Water (e.g. ad libitum): filtered tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 (+/-3)
- Humidity (%): 23.4 to >45
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 30 Nov 1998 to 03 Dec 1998
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): pure, considered 100% for this study - Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- 72h
- Number of animals or in vitro replicates:
- 6 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no rinsing was done
SCORING SYSTEM:
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- animal: #2, #3, #4, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #3, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversiblity not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2, #4, #5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #3, #4, #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2, #5
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
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