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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: Study meets generally accepted scientific principles, acceptable for assessment: non-GLP, no data on purity of test substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N-[6-(3-{6-[3-(6-formamidohexyl)-2,4-dioxo-1,3-diazetidin-1-yl]hexyl}-2,4-dioxo-1,3-diazetidin-1-yl)hexyl]formamide; N-{6-[3-(6-formamidohexyl)-2,4-dioxo-1,3-diazetidin-1-yl]hexyl}formamide
EC Number:
931-288-4
Molecular formula:
(C8H12N2O2)n
IUPAC Name:
N-[6-(3-{6-[3-(6-formamidohexyl)-2,4-dioxo-1,3-diazetidin-1-yl]hexyl}-2,4-dioxo-1,3-diazetidin-1-yl)hexyl]formamide; N-{6-[3-(6-formamidohexyl)-2,4-dioxo-1,3-diazetidin-1-yl]hexyl}formamide
Constituent 2
Reference substance name:
28182-81-2
Cas Number:
28182-81-2
IUPAC Name:
28182-81-2

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Sex: male
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co KG, Extertal, Germany
- Mean weight at study initiation: 2.7 kg
- Housing: singly
- Diet and water: ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18°C
- Humidity (%): 40 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left untreated eye surved as control
Amount / concentration applied:
100 µL
Duration of treatment / exposure:
The eye-lids were gently held together for about one second in order to prevent loss of the test compound. The eye was not rinsed after substance-application.
Observation period (in vivo):
Examinations were terminated after 7 days, since all changes had completely subsided then.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eye was not rinsed after substance-application.

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: For the 24 hours score fluorescein was used. The evaluation was carried out with the aid of an ophthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
>= 0 - <= 1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: mean score: 0.7
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
>= 0 - <= 1
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: mean score: 0.3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
>= 0 - <= 1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: mean score: 0.7
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4

Applicant's summary and conclusion

Executive summary:

An acute eye irritation/corrosion Test was conducted according to OECD TG 405. Only very slight conjunctival irritation was observed after 24, 48 and 72 hours (mean scores at time points 24, 48, and 72 h: cornea: 0, iris: 0, conjunctivae redness: 0.3, chemosis: 0.6). All effects were fully reversible after 7 days at the latest.