Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test was conducted according to EU Method B.5 and compliant with GLP. Read-across from supporting substance (structure analogue or surrogate). Test substance (source substance): EC No. 402-990-3

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Reaction mass mainly based on 2,3-dihydro-6-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene and 2,3-dihydro-5-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene
IUPAC Name:
Reaction mass mainly based on 2,3-dihydro-6-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene and 2,3-dihydro-5-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene
Constituent 2
Reference substance name:
A mixture mainly based on: 2,3-dihydro-6-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene; 2,3-dihydro-5-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene
EC Number:
402-990-3
EC Name:
A mixture mainly based on: 2,3-dihydro-6-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene; 2,3-dihydro-5-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene
IUPAC Name:
402-990-3

Test animals / tissue source

Species:
rabbit
Strain:
other: albino New Zealand

Test system

Amount / concentration applied:
54 mg
Duration of treatment / exposure:
Ocular reactions were evaluated at 24, 48, and 72 hours after the instillation of the test substance.
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: Overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at the end of observation period: 0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: Overall at 24, 48 and 72 h
Score:
0.45
Max. score:
0.67
Remarks on result:
other: Max. duation: 48 h; Max. value at the end of observation period: 0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: Overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Remarks on result:
other: Max. duation: 0 h; Max. value at the end of observation period: 0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: Overall at 24, 48 and 72 h
Score:
0.5
Max. score:
1
Remarks on result:
other: Max. duation: 24 h; Max. value at the end of observation period: 0

Any other information on results incl. tables

The mean scores were calculated for all the animals tested 24, 48 and 72 hours.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is not an eye irritant in rabbits.