Registration Dossier
Registration Dossier
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EC number: 944-989-5 | CAS number: 2156592-46-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions, read-across substance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,2,3-Propanetricarboxylic acid, 2-Hydroxy-, tris(C12-13-branched-alkyl)ester
- EC Number:
- 944-989-5
- Cas Number:
- 2156592-46-8
- Molecular formula:
- C42H80O7 - C45H86O7
- IUPAC Name:
- 1,2,3-Propanetricarboxylic acid, 2-Hydroxy-, tris(C12-13-branched-alkyl)ester
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Conelli - Arona Comense (NO), Italy
- Age at study initiation: no data
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: singly in stainless steel cages (dimensions: 450x500x380 mm)
- Diet: standard pellet complete diet ad libitum supplied by the authorized breeder RIEPER
- Water: filtered tap water from local network ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
Temperature and humidity were regulated by a conditioning plant and were continuously recorded, no further details mentioned
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 02-JUN-1992 To: 09-JUN-1992
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- at 1, 24, 48 and 72 hours and after 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed
SCORING SYSTEM: according to guideline
TOOL USED TO ASSESS SCORE: no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- other: 60 min
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritant / corrosive response data:
- for details see table below
Any other information on results incl. tables
Table: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
1/1/1/1/1/1 |
0/0/0/0/0/0 |
24 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/1/1/0/0 |
0/0/0/0/0/0 |
48 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/1/1/0/0 |
0/0/0/0/0/0 |
72 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/1/1/0/0 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0 |
0 |
0.33 |
0 |
Reversibility*) |
- |
- |
c. |
- |
Average time for reversion |
- |
- |
7 d |
- |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was not an eye irritant.
- Executive summary:
An ocular irritation test was carried out on test material Cosmacol ECI according to OECD Guideline 405.
The test was performed by placing the test material in a single dose in the conjunctival sac of 6 albino male rabbits at a dose of 0.1 mL/animal. The animals eyes were examined 1, 24, 48 and 72 hours after the beginning of the test. The ocular areas obvserved were the cornea, the iris and conjunctivae. The results showed a slight congestion of the conjunctivae in all 6 rabbits 1 h and in 2 of 6 animals 24, 48, 72 h
after the treatment. After 7 days it disappeared.
It was concluded that the read-across substance Cosmacol ECI is to be considered non-irritant to eyes.
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