Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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.