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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Part of the SNIF file, which was accepted by the Belgian national authority for NONS.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EEC Directive 92/69, B.5
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
441-100-8
EC Name:
-
Cas Number:
351197-46-1
Molecular formula:
Hill formula: C24 H48 N4 O6 CAS formula: C24 H48 O6 N4
IUPAC Name:
2-[2-(dimethylamino)ethoxy]ethyl N-{[1,3,3-trimethyl-5-(9-methyl-2-oxo-3,6-dioxa-1,9-diazadecan-1-yl)cyclohexyl]methyl}carbamate
Details on test material:
Nature of substance: undiluted

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
no data
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
1

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Value at end of observation period: 2
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Value at end of observation period: 2
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Value at end of observation period: 3
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Value at end of observation period: 1
Irritant / corrosive response data:
Reversibility of any observed effect: There was no indication of reversibility within 3 days.
Swelling with lids more than half closed was observed at 1h, obvious swelling with partial eversion of lids was present throughout the observation period. Assessment of the sclera was not possible at 1 hour due to the swelling of the conjunctivae but moderate reddening was subsequently observed from 24 to 72 hours. Increased ocular discharge was observed from 1 to 24 hours, and discharge with moistening of the lids and hair just adjacent to the lids was apparent from 48 to 72 hours. Blood was also present around the eye at the 1-hour reading and ruptured blood vessels were evident during the observation period.
Other effects:
The animal displayed signs of distress and pain during the examination. Based on the results the animal was prematurely sacrificed at the request of the Study Director and no further animals were treated.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information