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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study that meets accepted scientific standard, well document and acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test was performed according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Labelling Act Sect. 191.12 (February 1965).
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2,3-epoxypropyl) terephthalate
EC Number:
230-565-0
EC Name:
Bis(2,3-epoxypropyl) terephthalate
Cas Number:
7195-44-0
Molecular formula:
C14H14O6
IUPAC Name:
1,4-bis[(oxiran-2-yl)methyl] benzene-1,4-dicarboxylate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Healthy New Zealand White rabbits aged 12 - 16 weeks with average body weights of 2.93 kgs for the males and 2.80 kgs for the females, bred on the premises and maintained under semi-barrier system. The animals were acclimatized in the test area for one week prior to the start of the trial.
Experimental room was maintained at a temperature of 20C and a relative humidity of 50-70%. Light cycle of 10 Hours / 14 hours per day. A commercial irradiated diet was fed ad lib. and filtered sterile water was available at all times.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye serve as control
Amount / concentration applied:
100 mg of the test compound
Duration of treatment / exposure:
The eye lids were held closed for 1 second.
In three out of the six rabbits, after 30 seconds the compound was, as far as possible, flushed out of the eyes with approx. 200 mL of warm water.
Observation period (in vivo):
The rabbits were examined 1, 24, 48 and 72 hours after application as well as 6 and 10 days.
Number of animals or in vitro replicates:
6 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: in three animals the compound was flushed out with approx. 200 mL warm water
- Time after start of exposure: 30 seconds

SCORING SYSTEM:

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

No ulceration or opacity.................................................................................................................... 0
Scattered or diffuse areas of opacity ,details of iris clearly visible..............................................1
Easily discernible translucent area, details of iris slightly obscured...........................................2
Oaplescent area, no details of iris visible, size of pupil barely discernible.................................3
Opaque cornea, iris invisible...............................................................................................................4


IRIS
Normal.....................................................................................................................................................0
Folds above normal, congestion, swelling, moderate circumcorneal injection,
any of these or combination of any thereof, iris still reacting to light
(sluggish reaction is positive) .............................................................................................................1
No reaction to light, hemorrhage, gross destruction (any or all of these)...................................2

CONHJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)

vessels normal........................................................................................................................................0
vessels definitely injected above normal.............................................................................................1
More diffuse, deeper crimson red, individual vessels not easily discernible................................2
Diffuse beefy red.....................................................................................................................................3

Chemosis:

No swelling...............................................................................................................................................0
Any swelling above normal (including 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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
25
Max. score:
80
Reversibility:
other: Animals sacrificed after 6 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 h
Score:
22
Max. score:
80
Reversibility:
other: Animlas sacrificed after 6 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 h
Score:
28
Max. score:
80
Reversibility:
other: Animals sacrificed after 6 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24
Score:
2
Max. score:
3
Reversibility:
other: Animals sacrificed after 6 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
other: Animals sacrificed after 6 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
2.66
Max. score:
3
Reversibility:
other: Animals sacrificed after 6 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 h
Score:
2
Max. score:
4
Reversibility:
other: Animals sacrificed after 6 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 h
Score:
3
Max. score:
3
Reversibility:
other: Animals sacrificed after 6 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 h
Score:
2
Max. score:
4
Reversibility:
other: Animals sacrificed after 6 days
Irritant / corrosive response data:
Conjunctiva. A uery slight to mild reaction was seen in all treated eyes one hour after the application of the compound. By 24 hours this had
increased in severity in the unwashed eyes but had remained the same in the washed ones. By 72 hours all unwashed eyes were showing necrotic
areas, whereas one washed eye was normal at this time and the other 2 returned to normal by 6 days. There was no change in the unwashed eyes
by 6 days when the animals were killed. If sufficient time had been allowed to elapse it is considered there might have been some residual
scarring of the conjunctivae.

Cornea. Slight opacity with damage to the surface epithelium was seen in all treated eyes at one hour. This was still present at 24 hours inthe
3 unwashed eyes and 2/3 washed eyes. ' These 2 washed eyes had returned to normal by 48 hours and 10 days whereas 2/3 of the unwashed eyes
showed ulceration from 72 hours onwards. By 6 days there was slight pannus formation in the 3 unwashed eyes. It is considered that if sufficiënt
time had been allowed to elapse there might have been some residual . scarring of the cornea in the unwashed eyes.

Iris. Increased folding was seen in one unwashed eye at one hour and in 3 unwashed eyes and 2 washed eyes at 24 hours. The washed eyes
had returned to normal by 48 hours, but the unwashed eyes were still showing a reaction when the rabbits were killed at 6 days.

Washing the eyes reduced the severity of the reactions to a very great extent in that only slight reaction was present at 24 hours and all eyes
had returned to normal by 10 days.

Because of the severity of the reactions the 3 rabbits with unwashed eyes were killed after 6 days.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based on the above mentioned data and as the animals were sacrificed for animal welfare reasons the substance is considered to be corrosive.
Executive summary:

100 mg of the substance was instilled into the conjunctval sac of the left eye of six healthy new zealand white rabbits. The right eye served as control. After 30 seconds the substance was flushed out of the eyes of three rabbits with approx 200 mL water.

The rabbits were examined after 1, 24, 48, 72 hours as well as 6 and 10 days after treatment.

Washing the eyes reduced the severity of the reactions to a very great extent in that only slight reaction was present at 24 hours and all eyes had returned to normal by 10 days.

Because of the severity of the reactions the 3 rabbits with unwashed eyes were killed after 6 days.