Registration Dossier
Registration Dossier
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EC number: 310-154-3 | CAS number: 121158-58-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-09-18 until 1984-10-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to internationally accepted testing guideline, well documented
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- p-Isododecylphenol
- IUPAC Name:
- p-Isododecylphenol
- Details on test material:
- - Name of test material (as cited in study report): Isododecylphenol
- Molecular formula (if other than submission substance):
- Physical state: liquid
- Analytical purity: 97%
- Impurities (identity and concentrations): 3% Decylphenol
- Composition of test material, percentage of components: not mentioned
- Purity test date: not mentioned
- Lot/batch No.: not mentioned
- Production date of the lot/batch: 1984-03-22
- Stability under test conditions: not mentioned
- Storage condition of test material: not mentioned
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Small White Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.1 - 2.3 kg
- Housing: conventional, singly in stainless steel cages
- Diet (e.g. ad libitum): K4 complete feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GembH, Soest, Germany
- Water (e.g. ad libitum): Drinking 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
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- not rinsed
- Observation period (in vivo):
- 1, 24, 48 and 72 hours, and 6, 8, 10, 13, 15, 17 and 21 days after application
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed
- Time after start of exposure:
SCORING SYSTEM: acording to guideline
TOOL USED TO ASSESS SCORE: ophtmalic lamp, fluorescein 21 days after application
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 19.3
- Reversibility:
- not fully reversible within: 21 days
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 0.72
- Iris: 0.44
- Conjuntivae (Redness): 2.22
- Conjuntivae (Chemosis): 1.22 - Other effects:
- After 24 h eyes clotted, formation of secretion and animals bends its head, towards the application side showed two females, after 72 h all females and two males showed eyelids inflexibility.
Any other information on results incl. tables
Table #: Irritant/corrosive response data for each animal at each observation time of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
male: 1/2/3 - female: 4/5/6 |
male: 1/2/3 - female: 4/5/6 |
male: 1/2/3 - female: 4/5/6 |
male: 1/2/3 - female: 4/5/6 |
|
60 min |
0 / 0 / 0 - 0 / 0 / 1 |
0 / 0 / 1 - 0 / 0 / 1 |
2 / 2 / 2 - 2 / 2 / 2 |
1 / 1 / 1 - 2 / 2 / 1 |
24 h |
2 / 0 / 1 - 1 / 1 / 1 |
1 / 0 / 1 - 1 / 1 / 1 |
3 / 1 / 2 - 3 / 3 / 3 |
2 / 0 / 2 - 2 / 2 / 3 |
48 h |
1 / 0 / 1 - 0 / 2 / 1 |
0 / 0 / 1 - 0 / 1 / 0 |
2 / 1 / 2 - 2 / 3 / 3 |
1 / 0 / 1 - 1 / 2 / 2 |
72 h |
0 / 0 / 0 - 0 / 1 / 1 |
0 / 0 / 0 - 0 / 1 / 0 |
1 / 1 / 2 - 2 / 3 / 3 |
1 / 0 / 1 - 1 / 1 / 1 |
Average 24h, 48h, 72h |
0.72 |
0.44 |
2.22 |
1.22 |
Reversibility |
reversible 5 animals on day 8, irreversible 1 female after 21 days |
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Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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