Registration Dossier
Registration Dossier
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EC number: 275-164-1 | CAS number: 71076-48-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 26 Feb - 04 Mar 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
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:
- Fatty acids, C8-24
- EC Number:
- 275-164-1
- EC Name:
- Fatty acids, C8-24
- Cas Number:
- 71076-48-7
- Molecular formula:
- C8H16O2 - C24H48O2
- IUPAC Name:
- 71076-48-7
- Details on test material:
- - Name of test material (as cited in study report): Polyresidal F (FS 017) (destillation residue of unsaturated fatty acids)
- Physical state: black, waxy solid
- Analytical purity: no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Himalayan Chbb:HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Age at study initiation: adult animals
- Weight at study initiation: 2517.5 g (mean)
- Housing: individually in a rabbit battery (Fa. Heinkel, Kuchen, Germany)
- Diet: Altromin diet 2023 (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 3 days
reading time points: 1, 6, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 4 males
- Details on study design:
- PREPARATION OF THE TEST SUBSTANCE
The test item was prewarmed to enable the application of a fluidized test substance in the conjunctival sac of the right eye.
REMOVAL OF TEST SUBSTANCE
The test item was in contact with the eye permanently. No removal of the test item occured.
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:
- other: mean out of all 4 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:
- other: mean out of all 4 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:
- other: mean out of all 4 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.17
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- other: mean out of all 4 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- No reactions on iris or cornea were observed which was confirmed after fluorescein treatments.
Slight effects (grade 1) on the conjunctiva (redness) were observed in 3 animals which were fully reversible within 24 - 48 h in all animals (Table 2).
Two animals showed signs of exsudation (score 1 and 2, max. score: 4) 1 h after application which was fully reversible within 6 h.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DSD: not classified
CLP: not classified
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