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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1997/06/16 - 1997/06/19
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Dioctadecyl ether
EC Number:
228-567-1
EC Name:
Dioctadecyl ether
Cas Number:
6297-03-6
Molecular formula:
C36H74O
IUPAC Name:
1-(octadecyloxy)octadecane

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: 76410 Saint-Aubin-Les-Elbeuf, France
- Weight at study initiation: 2.1 kg
- diet: Complete pelleted rabbit maintenance diet Energie H326, COFNA (37000 - TOURS, FRANCE)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
in accordance with the requirements of the 86/609/EEC guideline

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: adjacent eye
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
no details given
Observation period (in vivo):
1h, 24h, 48h, 72h
Number of animals or in vitro replicates:
3 females
Details on study design:
The adjacent eye served as a control.

SCORING SYSTEM:

Conjunctivae
Chemosis (A): lids and/or nictitating membranes

No swelling 0
Any swelling above normal(includes nictitating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4

Discharge (B):

No discharge 0
Any amount different from normal (does not include small amounts observed in inner canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adjacent to the lids 2
Discharge with moistening of the lids and considerable area around the eye 3

Redness (C): refers to palpebral and bulbar conjuntivae, cornea and iris

Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red 3

Iris (D)

Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, 1
or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
No reaction to light, haemorrhage, gross destruction (any or all of these) 2

Cornea

Opacity (E): degree of density (area most dense are taken for reading)

No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight
dulling of normal lustre), details of iris clearly visible 1
Easily discernible translucent area, details of iris slightly obscured 2
Nacreous area, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible through the opacity 4

Area of cornea involved (F)

One-quarter (or less) but not zero 1
Greater than one-quarter-less than one-half. 2
Greater than one-half-less than three quarters 3
Greater than three-quarters-up to whole area 4


TOOL USED TO ASSESS SCORE:
Ocular reactions are performed with a U.V. and white magnification light. After recording the observations at 24 hours, the eyes of all rabbits are examined with the aid of fluorescein.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean
Time point:
other: 1h, 24h, 48h, 72h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean
Time point:
other: 1h, 24h, 48h, 72h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean
Time point:
other: 1h, 24h, 48h, 72h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #1
Remarks:
mean
Time point:
other: 1h, 24h, 48h, 72h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #2
Remarks:
mean
Time point:
other: 1h, 24h, 48h, 72h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #3
Remarks:
mean
Time point:
other: 1h, 24h, 48h, 72h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Remarks:
mean
Time point:
other: 1h, 24h, 48h, 72h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Remarks:
mean
Time point:
other: 1h, 24h, 48h, 72h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Remarks:
mean
Time point:
other: 1h, 24h, 48h, 72h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48h
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean
Time point:
other: 1h, 24h, 48h, 72h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean
Time point:
other: 1h, 24h, 48h, 72h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean
Time point:
other: 1h, 24h, 48h, 72h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal #1
Remarks:
mean
Time point:
other: 1h, 24h, 48h, 72h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal #2
Remarks:
mean
Time point:
other: 1h, 24h, 48h, 72h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal #3
Remarks:
mean
Time point:
other: 1h, 24h, 48h, 72h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
Opacity area
Basis:
animal #1
Remarks:
mean
Time point:
other: 1h, 24h, 48h, 72h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
Opacity area
Basis:
animal #2
Remarks:
mean
Time point:
other: 1h, 24h, 48h, 72h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
Opacity area
Basis:
animal #3
Remarks:
mean
Time point:
other: 1h, 24h, 48h, 72h
Score:
0
Max. score:
4

Any other information on results incl. tables

After 1h an outbreak of diffuse purple enanthemae with lacrimations; slight chemosis in one of them; after 24h a slight redness remains visible in the three animals with the persistence of the slight chemosis in one animal.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU