Registration Dossier
Registration Dossier
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EC number: 270-298-7 | CAS number: 68424-37-3
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:
- 26 Feb - 04 Mar 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study, tested with the source substance CAS 57-10-3. 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:
- 1 988
- 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:
- Palmitic acid
- EC Number:
- 200-312-9
- EC Name:
- Palmitic acid
- Cas Number:
- 57-10-3
- Molecular formula:
- C16H32O2
- IUPAC Name:
- palmitic acid
- Details on test material:
- - Name of test material (as cited in study report): Edenor C16 - 92/94 (FS 008)
- Physical state / appearance: white powder
- Analytical purity: no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Kleinrussen Chbb
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: HM / Fa. Thomae, Biberach, Germany
- Weight at study initiation: ca. 2640 g
- Housing: individually (Fa. Heinkel, Kuchen, Germany)
- Diet (ad libitum): Altromin diet 2023, Altromin GmbH, Lage, Germany
- Water (ad libitum): community tap water; ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 20 - 21
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eyes of the same animals were used for control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- permanent, without washing-off
- Observation period (in vivo):
- 3 days (since only minor scores were observed that fully returned to normal within 3 days the experiment was cancelled due to animal welfare reasons; therefore the reduced observation period does not represent a deviation to the OECD guideline)
- Number of animals or in vitro replicates:
- 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 4 animals
- Time point:
- other: mean 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 4 animals
- Time point:
- other: mean 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- 4 animals
- Time point:
- other: mean 24 - 48 - 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within:
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 4 animals
- Time point:
- other: mean 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- other: exudation
- Basis:
- mean
- Remarks:
- 4 animals
- Time point:
- other: mean 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
Any other information on results incl. tables
Tab.1: Conjunctival reactions after application of 0.1 g Edenor C16 - 92/94 (undiluted, permanent, 4 male rabbits)
Time point after application |
Redness |
Chemosis |
Exudation |
|||
Individual data |
Average |
Individual data |
Average |
Individual data |
Average |
|
60 min |
1 / 1 / 1 / 1 |
1.00 |
0 / 1 / 1 /1 |
0.75 |
0 / 0 / 0 / 1 |
0.25 |
6 h |
1 / 2/ 1 / 1 |
1.25 |
0 / 0 / 0 / 0 |
0 |
2 / 0 / 0 / 1 |
0.75 |
24 h |
1 / 1 / 1 / 1 |
1.00 |
0 / 0 / 0 / 0 |
0 |
0 / 0 / 0 / 0 |
0 |
48 h |
0 / 0 / 0 / 0 |
0 |
0 / 0 / 0 / 0 |
0 |
0 / 0 / 0 / 0 |
0 |
72 h |
0 / 0 / 0 / 0 |
0 |
0 / 0 / 0 / 0 |
0 |
0 / 0 / 0 / 0 |
0 |
Animal No. (from left to right) 790, 796, 798, 799
Reactions on the cornea and iris were not observed. The conjunctival reactions were slight and disappeared totally within 48 hours. Palmitic acid is not irritating to eyes / mucosa under the test conditions.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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