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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:
key study
Study period:
July 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

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:
: 0.05 mL instead of 0.1 mL instilled; observation only 24 h instead of 72 h; lack of details on test substance
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Fatty acids, C16-18, 2-ethylhexyl esters
Cas Number:
91031-48-0
Molecular formula:
C24H48O2 to C26H52O2
IUPAC Name:
Fatty acids, C16-18, 2-ethylhexyl esters
Constituent 2
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
IUPAC Name:
91031-48-0
Details on test material:
- Name of test material (as cited in study report): Octyl Stearate

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated left eye
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, eye examinations at 2, 6 and 24 hours after instillation
Number of animals or in vitro replicates:
2
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:
mean
Remarks:
of 2 tested animals at
Time point:
other: 24 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 2 tested animals at
Time point:
other: 24 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 2 tested animals at
Time point:
other: 24 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 2 tested animals at
Time point:
other: 24 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU