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EC number: 209-099-7 | CAS number: 555-45-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 27 Nov - 30 Nov 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministerium für Umwelt und Naturschutz, Landwirtschaft und Verbraucherschutz des Landes Nordrhein-Westfalen, Düsseldorf, Germany
Test material
- Reference substance name:
- Dodecanoic acid, ester with 1,2,3-propanetrial, acetylated
- Cas Number:
- 97593-30-1
- Molecular formula:
- not applicable, substance is multi constituent
- IUPAC Name:
- Dodecanoic acid, ester with 1,2,3-propanetrial, acetylated
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Crl:KBL(NZW)BR
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Kißlegg, Germany
- Age at study initiation: young adults
- Weight at study initiation: 3.1-3.5 kg
- Housing: individually in cage units Metall/Noryl. Excrement trays below the cages contained low dust wood granulate bedding. The wood granulate was changed at least twice weekly. The animals were regularly transferred to clean cages. The animal room was provided with sound from a radio program.
- Diet: standard diet "Ssniff K-Z" 4mm (Ssniff Spezialdiäten GmbH, Soest, Germany), approx. 100 g per animal per day. To satisfy the needs of roughage, hay was offered additionally (hay, irradiated, delivered by Harlan Winkelmann, Borchen, Germany; respectively hay pellets delivered by Ssniff Spezialdiäten GmbH, Soest, Germany).
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 25
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 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:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- 1 h post-instillation: moderate conjunctival redness and very slight chemosis were observed in all 3 animals. No corneal opacity or iritis was noted in any animal.
24 h post-instillation: slight conjunctival redness and very slight chemosis were observed in 3/3 and 2/3 animals, respectively. Both effects were fully reversible after further 24 h (48 h reading). No corneal opacity or iritis was noted in any animal.
48-72 h post-instillation: no eye effects were observed in any animal. - Other effects:
- No further local effects were reported. There were no systemic intolerance reactions.
Any other information on results incl. tables
Table 1. Results of eye irritation study.
| Rabbit # | Time [h] | conjunctivae | iris | cornea | |
| redness | swelling | ||||
| 1 | 1 | 2 | 1 | 0 | 0 |
| 24 | 1 | 0 | 0 | 0 | |
| 48 | 0 | 0 | 0 | 0 | |
| 72 | 0 | 0 | 0 | 0 | |
| average | 0.3 | 0.0 | 0.0 | 0.0 | |
| 2 | 1 | 2 | 1 | 0 | 0 |
| 24 | 1 | 1 | 0 | 0 | |
| 48 | 0 | 0 | 0 | 0 | |
| 72 | 0 | 0 | 0 | 0 | |
| average | 0.3 | 0.3 | 0.0 | 0.0 | |
| 3 | 1 | 2 | 1 | 0 | 0 |
| 24 | 1 | 1 | 0 | 0 | |
| 48 | 0 | 0 | 0 | 0 | |
| 72 | 0 | 0 | 0 | 0 | |
| average | 0.3 | 0.3 | 0.0 | 0.0 | |
| Time [h] | conjunctivae | iris | cornea | ||
| redness | swelling | ||||
| average score |
1 | 2.00 | 1.00 | 0.00 | 0.00 |
| 24 | 1.00 | 0.67 | 0.00 | 0.00 | |
| 48 | 0.00 | 0.00 | 0.00 | 0.00 | |
| 72 | 0.00 | 0.00 | 0.00 | 0.00 | |
| 24+48+72 | 0.33 | 0.22 | 0.00 | 0.00 | |
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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