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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Qualifier:
according to guideline
Guideline:
other: JMAFF, Japanese Ministry of Agriculture, Forestry and Fisheries, November 2000, including the most recent partial revisions
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
benzene, 1,4-bis[2-[3,5-dimethoxy-4-(1- methylpropoxy)phenyl]ethenyl]-
Cas Number:
586410-55-1
Molecular formula:
C34 H42 O6
IUPAC Name:
benzene, 1,4-bis[2-[3,5-dimethoxy-4-(1- methylpropoxy)phenyl]ethenyl]-
Details on test material:
Read-across from CASRN586410-55-1 to the substance defined in section 1 allowed by belgian authority.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
3 males (at least 6 weeks old and body weights at least 1.0kg)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
67.8 (65.5-69.5)mg
Duration of treatment / exposure:
24hours
Observation period (in vivo):
mortality/viability: twice daily
toxicity: at least once daily
body weight: day of treatment (prior to application) and at termination
irritation: +/- 1, 24, 48 and 72 hours after instillation of the test substance
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(individual score)
Time point:
other: at 1, 24, 48 and 72 h
Score:
<= 2
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(individual score)
Time point:
other: at 1, 24, 48 and 72 h
Score:
<= 2
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(individual score)
Time point:
other: at 1, 24, 48 and 72 h
Score:
<= 2
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
(discharge)
Basis:
animal #1
Remarks:
individual score
Time point:
other: at 1, 24, 48 and 72 h
Score:
<= 1
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Remarks:
(discharge)
Basis:
animal #2
Remarks:
(individual score)
Time point:
other: at 1, 24, 48 and 72 h
Score:
<= 1
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Remarks:
(discharge)
Basis:
animal #3
Remarks:
(individual score)
Time point:
other: at 1, 24, 48 and 72 h
Score:
<= 1
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(individual score)
Time point:
other: at 1, 24, 48 and 72 h
Score:
<= 1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(individual score)
Time point:
other: at 1, 24, 48 and 72 h
Score:
<= 1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(individual score)
Time point:
other: at 1, 24, 48 and 72 h
Score:
<= 1
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
cornea opacity score
Remarks:
(opacity, area/fluor area %)
Basis:
animal #1
Remarks:
(individual score)
Time point:
other: at 1, 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
(opacity, area/fluor area %)
Basis:
animal #2
Remarks:
(individual score)
Time point:
other: at 1, 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
(opacity, area/fluor area %)
Basis:
animal #3
Remarks:
(individual score)
Time point:
other: at 1, 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(individual score)
Time point:
other: at 1, 24, 48 and 72 h
Score:
<= 1
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(individual score)
Time point:
other: at 1, 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(individual score)
Time point:
other: at 1, 24, 48 and 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
There was no evidence of ocular corrosion.
Other effects:
1. colouration/remnants: no staining of (peri)ocular tissues by the test substance was observed. remnants of the test substance were present in the eye on day 1.
2. toxicity/mortality: no symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: OECD (1998) and EU (67/548/EEC)
Conclusions:
not classified