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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
05 Jun 1991 - 08 Jun 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Only 72 h observation period, analytical purity of test substance not clearly specified.
Justification for type of information:
Refer to category justification provided in the category object.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
analytical purity of test substance not clearly specified; observation period terminated at 72 h, although not fully reversible at that point
Qualifier:
according to guideline
Guideline:
other: FHSA/CPSC: Federal Hazardous Substances Control Act, 16 CFR 1500.42
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylene distearate
EC Number:
211-014-3
EC Name:
Ethylene distearate
Cas Number:
627-83-8
Molecular formula:
C38H74O4
IUPAC Name:
ethane-1,2-diyl dioctadecanoate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Davidson's Mill Farm, S. Brunswick, NJ, USA
- Housing: individually in suspended stainless steel caging with mesh floors.
- Diet: pelleted Purina Rabbit Chow, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 34 or 51 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5-21.5

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 g



Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
72 h
Reading time points: 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:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal: #2, #3, #4, #5 and #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
Cornea: No effects on cornea were observed during the study period in any animal.
Iris: No iritis was observed in any animal at any reading time point.
Conjunctivae: After 24 h in 4/6 animals mild redness was observed and in 2/6 a moderate redness was apparent. At the 48 h reading time point in 4/6 animals mild redness was visible being fully reversible in 2 animals and persistent up to the 72 h reading time point in 2 animals, as well.
After 24 h in 1/6 animals mild chemosis was apparent being fully reversible within 48 h.
Other effects:
All animals appeared active and healthy. Apart from the eye irritation noted in Table 1, there were no signs of systemic toxicity, adverse pharmacologic effects or abnormal behavior.

Any other information on results incl. tables

Table1. Results of eye irritation study.

Rabbit # Time [h] conjunctivae   iris cornea
redness swelling
8797 24 1 1 0 0
48 1 0 0 0
72 1 0 0 0
average 1.0 0.3 0.0 0.0
8798 24 1 0 0 0
48 1 0 0 0
72 0 0 0 0
average 0.7 0.0 0.0 0.0
8799 24 2 0 0 0
48 1 0 0 0
72 1 0 0 0
average 1.3 0.0 0.0 0.0
8800 24 1 0 0 0
48 0 0 0 0
72 0 0 0 0
average 0.3 0.0 0.0 0.0
8801 24 2 0 0 0
48 1 0 0 0
72 0 0 0 0
average 1.0 0.0 0.0 0.0
8802 24 1 0 0 0
48 0 0 0 0
72 0 0 0 0
average 0.3 0.0 0.0 0.0
   
Time [h] conjunctivae   iris cornea
  redness swelling    
 average 24 1.33 0.17 0.00 0.00
48 0.67 0.00 0.00 0.00
72 0.33 0.00 0.00 0.00
24+48 +72 0.78 0.06 0.00 0.00

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.