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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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