Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study already evaluated and accepted by national autorities. Information from migrated NONS file as per inquiry # [06-0000021278-68-0000].

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Approximately Annex V
Deviations:
yes
Remarks:
test substance applied to corneal surface
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
405-370-0
EC Name:
-
Cas Number:
6334-25-4
Molecular formula:
C14H28N2O6
IUPAC Name:
N,N,N',N',-tetrakis(2-hydroxyethyl)hexanediamide
Details on test material:
Nature of substance: Ground powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Amount / concentration applied:
100 mg
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 4 h
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 4 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 4 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 4 h
Score:
0
Other effects:
No sign of eye irritation was observed at any time during the study

Applicant's summary and conclusion

Interpretation of results:
other: not classified