Registration Dossier
Registration Dossier
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EC number: 939-270-8 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1984-05-30 - 1984-06-20
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well conducted study similar to guideline (limited documentation, no specification on washing, scoring system in percentage of maximal possible reaction, 48 hours observation period)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- limited documentation, not specification on washing, scoring system in percentage of maximal possible reaction, 48 hours observation period
- GLP compliance:
- no
Test material
- Reference substance name:
- Fatty acids, C16-18, 2-hexyldecyl esters
- EC Number:
- 309-832-1
- EC Name:
- Fatty acids, C16-18, 2-hexyldecyl esters
- Cas Number:
- 101227-09-2
- IUPAC Name:
- 101227-09-2
- Details on test material:
- - Name of test material (as cited in study report): Isohexadecylstearat
No further details provided
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean 4420 g
No additional details provided.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Not specified (contact period was reported to be 10 s)
- Observation period (in vivo):
- 48 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified
SCORING SYSTEM: the irritation (cornea, iris, conjuctivae) reaction were scored in percentage of the maximal possible reaction, but no discrimination was done for conjunctivae reaction (swelling or redness).
The results are therefore evaluated in a worst case approach, by attributing the full reported reactions (percentages, as described above) equally to conjunctivae redness and to conjunctivae swelling. The percentages will be converted to the OECD guideline scores as follows: 1) for conjunctivae redness, up to 100% will be considered to correspond to a OECD score of 3, up to 66% to 2 and up to 33% to 1); for conjunctivae swelling, up to 100% will be considered to correspond to a swelling score of 4, up to 75% to 3, up to 50% to 2, and up to 25% to 1.
TOOL USED TO ASSESS SCORE: not specified.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- other: 24-48 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- other: 24-48 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- of all animals
- Time point:
- other: 24-48 hours
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Original values: 36.5% of the maximal possible conjunctivae reaction (not specified if redness or swelling) was observed 1 hour after treatment, 20.0% 6 hours after treatment, 3.5% 24 hours after treatment, and 0% 48 hours after treatment.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- other: 24-48 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Original values: 36.5% of the maximal possible conjunctivae reaction (not specified if redness or swelling) was observed 1 hour after treatment, 20.0% 6 hours after treatment, 3.5% 24 hours after treatment, and 0% 48 hours after treatment.
- Irritant / corrosive response data:
- Neither cornea nor iris reactions were observed up to the end of the observation period. A moderate conjunctivae reaction was observed from 1 hour after treatment, but was completely reversible within 48 hours observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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