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EC number: 250-705-4 | CAS number: 31566-31-1
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:
- 11 Jan - 11 Mar 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study. According 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:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: M.A.F.F. No. 4200 (1985)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Glycerides, C16-18 mono- and di-
- EC Number:
- 286-490-9
- EC Name:
- Glycerides, C16-18 mono- and di-
- Cas Number:
- 85251-77-0
- Molecular formula:
- C19H38O4, C21H42O4, C35H68O5, C39H76O5
- IUPAC Name:
- Glycerides, C16-18 mono- and di-
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: white powder
- Analytical purity: considered as 100 % for the study
- Batch no.: 21150
- Storage conditions: at room temperature
- Expiry date: 2000-08-01
- Other: pH = 5.8;
- Other: volumetric mass = 0.54 g/mL
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, Chalaronne, France
- Age at study initiation: about 3 months
- Weight at study initiation: 2.38-2.66 kg
- Housing: barrier protected unit, individually in stainless steel cages
- Diet: about 150 g/animal/day pelleted complete rabbit diet 112 C-10 (Usine d'Alimentation Rationnelle, Epinay-sur-Orge, France)
- Water: softened and filtered mains drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 3
- Humidity (%): > 45%
- Air changes (per hr): min. 12
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 25 Jan 1999 To: 28 Jan 1999
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL (54 mg)
The test substance was crushed to a fine powder for eye treatment. - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 6
- Details on study design:
- 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:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.11
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Slight to moderate effects on the conjunctivae (redness and chemosis) and slight effects on the iris (congestion) were observed in all animals 1 h after test substance instillation. In a single animal, effects on the iris persisted up to 48 h and reversed thereafter. No effects on cornea were observed in any animal tested.
- Other effects:
- No further local or systemic effects were observed.
Any other information on results incl. tables
Table 1. Results of eye irritation study
Rabbit # |
Time [h] |
conjunctivae |
|
iris |
cornea |
redness |
chemosis |
||||
1 |
1 |
1 |
1 |
1 l |
0 h |
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0 |
0 |
0 |
0 |
|
2 |
1 |
1 |
0 |
1 c |
0 |
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0 |
0 |
0 |
0 |
|
3 |
1 |
2 |
1 |
1 c |
0 |
24 |
0 |
0 |
1 l |
0 |
|
48 |
0 |
0 |
1 l |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0 |
0 |
0.67 |
0 |
|
4 |
1 |
2 |
1 |
1 l |
0 |
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0 |
0 |
0 |
0 |
|
5 |
1 |
2 |
2 |
1 l |
0 |
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0 |
0 |
0 |
0 |
|
6 |
1 |
1 |
1 |
1 l |
0 |
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0 |
0 |
0 |
0 |
|
|
|
||||
Time [h] |
conjunctivae |
|
iris |
cornea |
|
|
redness |
swelling |
|
|
|
average |
1 |
1.50 |
1.00 |
1 |
0 |
24 |
0.00 |
0.00 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
24+48+72 |
0 |
0 |
0.11 |
0 |
|
h = slight adherence of the test article to the corneal surface; c = circumcorneal injections + congestions of the iris; l = circumcorneal injections
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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