Registration Dossier
Registration Dossier
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EC number: 915-687-0 | CAS number: 1065336-91-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From May. 14, 1979 to June 5, 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- treated eye was rinsed with physiological saline in 3 of the 6 rabbits
- GLP compliance:
- no
Test material
- Reference substance name:
- 1-methyl 1,2,2,6,6-pentamethylpiperidin-4-yl decanedioate; bis(1,2,2,6,6-pentamethylpiperidin-4-yl) decanedioate
- EC Number:
- 915-687-0
- Cas Number:
- 1065336-91-5
- Molecular formula:
- unspecified
- IUPAC Name:
- 1-methyl 1,2,2,6,6-pentamethylpiperidin-4-yl decanedioate; bis(1,2,2,6,6-pentamethylpiperidin-4-yl) decanedioate
- Details on test material:
- - Physical state: Liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: IVANOVAS, 7964 Kisslegg/Allgäu, Germany and MADOERIN AG, 4414 Füllinsdorf, Switzerland
- Age at study initiation: Not reported
- Weight at study initiation: 2 to 3 kg
- Housing: Housed individually in metal cages
- Diet: Standard rabbit food, NAFAG, No. 814, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: Minimum of 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 14 hrs dark/10 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single exposure: 30 seconds for rinsed eyes, substance not removed at all for unrinsed eyes
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): In 3 of the 6 rabbits, the treated eye was flushed with 10 mL of physiological saline
- Time after start of exposure: Approximately 30 seconds after treatment (for 3 of the 6 rabbits)
SCORING SYSTEM: Irritation reactions were assessed according to the same scale provided in the OECD guideline, with the exception of 1 criteria (additional changes to discharge were included in addition to the other parameters).
TOOL USED TO ASSESS SCORE: Eye irritation was appraised with a slit lamp on day 1, 2, 3, 4, and 7 for each individual rabbit.
Calculation of the primary eye irritation index:
The mean reaction scores for cornea, iris, and conjunctiva observed after 1, 2, 3, 4, and 7 days were summed up and the sum divided by 5. This procedure was carried out separately for unrinsed and rinsed eyes, respectively. The conjunctivae score includes observations for redness, chemosis, and discharge.
Index:
0 - 10 = minimal
11 - 25 = slight
26 - 55 = moderate
56 - 84 = marked
above 84 = extreme
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- unrinsed or rinsed eyes
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Remarks:
- unrinsed or rinsed eyes
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- unrinsed or rinsed eyes
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Remarks:
- unrinsed or rinsed eyes
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- All scores recorded for all animals at all tim points were zero. The primary irritation index for unrinsed or rinsed eyes was equal to 0.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this experiment the test material was found to cause no irritation when applied to the rabbit eye mucosa.
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