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EC number: 248-688-3 | CAS number: 27841-06-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 - 13 Sep 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The analytical purity of the test substance was not specified.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: Dose selection according to EPA Federal Register, Vol. 50, No. 188, Friday , September 27, 1985
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2-dimethyl-1,3-propanediyl didecanoate
- EC Number:
- 248-688-3
- EC Name:
- 2,2-dimethyl-1,3-propanediyl didecanoate
- Cas Number:
- 27841-06-1
- Molecular formula:
- C25H48O4
- IUPAC Name:
- 3-(decanoyloxy)-2,2-dimethylpropyl decanoate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hare-Marland, Hewitt, USA
- Age at study initiation: adult animals
- Housing: animals were housed individually in cages
- Diet: Purina Lab Rabbit ChowR, ad libitum
- Water: fresh tap water, ad libitum (analyses were performed)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
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:
- 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:
- 3 males and 3 females
- Details on study design:
- SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- other: each of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- At the 1-hour reading time point, 4/6 animals showed conjunctivae (score 2), which disappeared after 24 h in 1/4 animals and was attenuated (score 1) in 3/4 animals. In 2/4 animals slight conjunctivae (score 1) was observed at the 1-hour reading time point, which remained stable until 24 h in one of the 2 animals and was augmented (score 2) in the other animal. The effects had cleared completely within 48 h.
At the 1-hour reading time point, 2/6 animals showed slight swelling (chemosis), which was reversed after 24 h in one and after 48 h in the other animal.
No further eye irritation effects (opacity or effect on iris) were observed in any rabbit at any time point.
Any other information on results incl. tables
Table 1: Individual scores of eye irritation
rabbit # |
time [h] |
conjunctivae |
iris |
cornea |
||
redness |
chemosis |
|||||
male |
1 |
1 |
2 |
0 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
||
48 |
0 |
0 |
0 |
0 |
||
72 |
0 |
0 |
0 |
0 |
||
mean |
0.3 |
0.0 |
0.0 |
0.0 |
||
2 |
1 |
2 |
0 |
0 |
0 |
|
24 |
1 |
0 |
0 |
0 |
||
48 |
0 |
0 |
0 |
0 |
||
72 |
0 |
0 |
0 |
0 |
||
mean |
0.3 |
0.0 |
0.0 |
0.0 |
||
3 |
1 |
2 |
1 |
0 |
0 |
|
24 |
0 |
0 |
0 |
0 |
||
48 |
0 |
0 |
0 |
0 |
||
72 |
0 |
0 |
0 |
0 |
||
mean |
0.0 |
0.0 |
0.0 |
0.0 |
||
female |
4 |
1 |
1 |
0 |
0 |
0 |
24 |
2 |
0 |
0 |
0 |
||
48 |
0 |
0 |
0 |
0 |
||
72 |
0 |
0 |
0 |
0 |
||
mean |
0.7 |
0.0 |
0.0 |
0.0 |
||
5 |
1 |
1 |
1 |
0 |
0 |
|
24 |
1 |
1 |
0 |
0 |
||
48 |
0 |
0 |
0 |
0 |
||
72 |
0 |
0 |
0 |
0 |
||
mean |
0.3 |
0.3 |
0.0 |
0.0 |
||
6 |
1 |
2 |
0 |
0 |
0 |
|
24 |
1 |
0 |
0 |
0 |
||
48 |
0 |
0 |
0 |
0 |
||
72 |
0 |
0 |
0 |
0 |
||
mean |
0.3 |
0.0 |
0.0 |
0.0 |
||
m/f |
1 - 6 |
total mean |
0.3 |
0.1 |
0.0 |
0.0 |
The mean is calculated only for the values 24 -72 h.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
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