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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Test substance purity not specified, methodological differences, only 0.05 mL test substance evaluated, only 24-h reading, only 24-h observation period.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
test substance purity not specified, methodological differences, only 0.05 mL test substance evaluated, only 24-h reading, only 24-h observation period
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, C16-18, 2-ethylhexyl esters
EC Number:
292-951-5
EC Name:
Fatty acids, C16-18, 2-ethylhexyl esters
Cas Number:
91031-48-0
Molecular formula:
C24H48O2 to C26H52O2

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated left eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 mL undiluted test substance
Duration of treatment / exposure:
single eye instillation
Observation period (in vivo):
24 hours

Reading time points: 2, 6 and 24 h after instillation
Number of animals or in vitro replicates:
2 (male)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2
Remarks:
mean of reading at
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
not determinable because of methodological limitations
Irritation parameter:
iris score
Basis:
animal: #1, #2
Remarks:
mean of reading at
Time point:
24 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Remarks on result:
not determinable because of methodological limitations
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2
Remarks:
mean of reading at
Time point:
24 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Remarks on result:
not determinable because of methodological limitations
Irritation parameter:
chemosis score
Basis:
animal: #1, #2
Remarks:
mean of reading at
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
not determinable because of methodological limitations
Irritant / corrosive response data:
One animal showed mild conjunctival erythema 2 hours after instillation, which disapperaed completely within 6 hours.

Applicant's summary and conclusion

Interpretation of results:
other: the results of this study can only be read together with other source substance data.
Conclusions:
The test substance was not irritating in this test, however, only 0.05 mL test substance evaluated and only 24-h reading.