Registration Dossier
Registration Dossier
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EC number: 273-295-9 | CAS number: 68955-98-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 19 Jun 1989 - 26 Jun 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study, tested with the source substance isooctadecanoic acid (CAS No. 30399-84-9). In accordance to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Isooctadecanoic acid
- EC Number:
- 250-178-0
- EC Name:
- Isooctadecanoic acid
- Cas Number:
- 30399-84-9
- IUPAC Name:
- 16-methylheptadecanoic acid
- Details on test material:
- - Name of test material (as cited in study report): Prisorine 3505 Acide Isostearique
- Physical state: liquid
- Analytical purity: no data
- Storage condition of test material: at room temperature
- Other: light yellow
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage des Feuilletas
- Weight at study initiation: 2 ± 0.2 kg
- Housing: individually housed in stainless steel cages (61x46x34 cm) with a grid floor
- Diet (ad libitum): UAR 112
- Water (ad libitum): tap water
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 5
- Humidity (%): 55 ± 25
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light): 12 per day, in a complementary way with natural and artificial lighting
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- 72 h. Reading time points: 1, 24, 48, 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize scores
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, 2, 3
- Time point:
- other: mean over 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, 2, 3
- Time point:
- other: mean over 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, 2, 3
- Time point:
- other: mean over 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- at 24 h reading
- Remarks on result:
- other: effects occurred after 1 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, 2, 3
- Time point:
- other: mean over 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- at 48 h reading
- Irritant / corrosive response data:
- A slight enanthema together with slight chemosis was observed in all 3 animals at the 1 hour reading. Enanthema remained during 48 hours in one animal and only 24 hours in the other two. Not any lesion of iris or cornea was recorded.
Any other information on results incl. tables
The irritative phenomena were minor and not any lesion was seen after 48 hours.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance does not fulfil the requirements to be classified according to DSD and CLP criteria for classification and labelling.
DSD: no classification
CLP: no classification
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