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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study undertaken to GLP.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
other: 84/449/EWG
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
406-040-9
EC Name:
-
Cas Number:
125643-61-0
Molecular formula:
C24 H40 O3 C25 H42 O3 C26 H44 O3
IUPAC Name:
C7-9-(branched)-alkyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
- Concentration (if solution):

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: Overall at 24, 48 and 72h
Score:
0.33
Reversibility:
fully reversible within: 3 days.
Remarks on result:
other: No other data
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: Overall at 24, 48 and 72h
Score:
0.66
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: No other data
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: Overall at 24, 48 and 72h
Score:
0.66
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: No other data
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: Overall at 24, 48 and 72h.
Score:
0
Remarks on result:
other: No other data.
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: Overall at 24, 48 and 72h
Score:
0
Remarks on result:
other: No other data.
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: Overall at 24, 48 and 72h.
Score:
0
Remarks on result:
other: No other data.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: Overall at 24, 48 and 72h.
Score:
0
Remarks on result:
other: No other data.
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: Overall at 24, 48 and 72h.
Score:
0
Remarks on result:
other: No other data.
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: Overall at 24, 48 and 72 h.
Score:
0
Remarks on result:
other: No other data.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: Overall at 24. 48 and 72h.
Score:
0
Remarks on result:
other: No other data.
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: Overall at 24, 48 and 72h.
Score:
0
Remarks on result:
other: No other data.
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: Overall at 24, 48 and 72h.
Score:
0
Remarks on result:
other: No other data.

Applicant's summary and conclusion

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