Registration Dossier
Registration Dossier
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EC number: 295-653-3 | CAS number: 92113-48-9
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:
- July 10th, 1989 - July 13th, 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions. Limited details on study 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:
- yes
- Remarks:
- Limited details on study substance
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, C16-18, triesters with trimethylolpropane
- EC Number:
- 293-037-9
- EC Name:
- Fatty acids, C16-18, triesters with trimethylolpropane
- Cas Number:
- 91050-90-7
- IUPAC Name:
- 91050-90-7
- Details on test material:
- - Physical state: solid, white
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Kleinrusse, Chbb
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach, Deutschland
- Age at study initiation: 6 months
- Weight at study initiation: 2550 g
- Diet: Altromin 2023 ad libitum
- Water:ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (slightly warmed) - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, rinsed with water
- Time after start of exposure: 24 h
SCORING SYSTEM: According to 84/449/EWG
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of all three animals
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effect
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all three animals
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks:
- No effect
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of all three animals
- Time point:
- other: 2 h4, 48 h and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: No effect
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all three animals
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effect
Any other information on results incl. tables
Animal |
Hours after application |
|||||||||||||||||||
1 |
24 |
48 |
72 |
|||||||||||||||||
A |
B |
C |
D |
E |
A |
B |
C |
D |
E |
A |
B |
C |
D |
E |
A |
B |
C |
D |
E |
|
1192 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1193 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1195 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
A = Corneal Score
B = Iris Score
C = Erythema Score
D = Chemosis Score
E = Exsudation Score
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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