Registration Dossier
Registration Dossier
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EC number: 220-342-6 | CAS number: 2726-73-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Octadecane-1,12-diol
- EC Number:
- 220-342-6
- EC Name:
- Octadecane-1,12-diol
- Cas Number:
- 2726-73-0
- Molecular formula:
- C18H38O2
- IUPAC Name:
- octadecane-1,12-diol
- Details on test material:
- - Name of test material (as cited in study report): Oxystearylalkohol
- Physical state: white flaky solid
- Lot/batch No.: SAT 90-178
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Kleinrusse, Chbb:HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Fa. Thomae, Biberach/D
- Weight at study initiation: ca. 2550 g
- Age at study initiation: 7 months
- Housing: Individual housing in rabbit cages (Fa. Heinkel, 7343 Kuchen/D)
- Diet: Altromin-Haltungsdiät 2023 (Fa. Altromin GmbH, Lage/D),ad libitum
- Water: Tap water, ad libitum
- Acclimation period: for at least 1 week.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: the substance was washed out with tap water
- Time after start of exposure: 24 hours
SCORING SYSTEM: As described in EU Method B5 and OECD 405
TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, and #3
- Time point:
- other: Mean of 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, and #3
- Time point:
- other: Mean of 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, and #3
- Time point:
- other: Mean of 24, 48, 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2
- Time point:
- other: Mean of 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, and #3
- Time point:
- other: Mean of 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- A slight reddening of the conjunctivae in two animals until the 24-hour assessment was observed. After 48 hours all animals were without symptoms.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the substance was considered not irritating to the eye.
- Executive summary:
The eye irritation test was performed according to OECD 405 and in compliance with GLP. In this study, three Kleinrusse, Chbb:HM rabbits were exposed to 0.1g test substance for 24 hours and after exposure the eyes were rinsed with warm water. The effects were scored after 1, 24, 48 and 72 hours and the rabbits were observed for 72 hours. Effects on the cornea and iris were not observed and no chemosis was observed. A slight reddening of the conjunctivae in two animals until the 24 -hour assessment was observed. The mean score of 24, 48 and 72 hours was 0.33 for both animals. After 48 hours all animals were without symptoms. Under the conditions of this study the substance was considered not irritating to the eye.
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