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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study under GLP without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Poly(oxy-1,2-ethanediyl), a,a',a'',a'''-[1,2-ethanediylbis(nitrilodi-2,1-ethanediyl)]tetrakis[w-hydroxy-
EC Number:
608-035-9
Cas Number:
27014-42-2
IUPAC Name:
Poly(oxy-1,2-ethanediyl), a,a',a'',a'''-[1,2-ethanediylbis(nitrilodi-2,1-ethanediyl)]tetrakis[w-hydroxy-

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand albino rabbit
Details on test animals or tissues and environmental conditions:
Species New Zealand albino rabbit
Strain Chbb: NZW (SPF)
Origin Chemical pharmaceutical factory Dr. K. Thomae 88400 Biberach
Number of animals 3
Body weight at start 3.77 - 3.92 kg
of the study
Animal maintenance in fully air-eonditioned rooms in separate eages arranged in a battery
Room temperature 20 ± 3°C
Relative humidity 50±20 %
Lighting time 12 hours daily
Aeclimatization 1 week under study eonditions
Food ssniff" K-H (V2333), ad libitum and hay (approx. 15g daily)
Water water from automatic water dispensers, ad libitum
Animal identifieation numbered ear tags

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml per eye
Duration of treatment / exposure:
72h
Observation period (in vivo):
14d
Number of animals or in vitro replicates:
3
Details on study design:
About 24 hours before the start of the study the test eyes of all animals were examined under UV light for cornealiesions after instillation of one drop of a 0.01 % fluorescein-sodium solution. Only animals without ocular abnormalities were used for the study.

0.1 ml of the substance was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control.

24 hours after application and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37°C.

The eyes were exarnined 1, 24, 48 and 72 hours after application of the test substance.
At 24 and 72 hours as well as after 7 and 14 days, the eyes were also examined for corneaI lesions under UV light after instillation of one drop of 0.01 %
f1uorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically. All other changes or toxic effects were recorded. Since effects were still present in the eyes after 72 hours, further examinations were carried out after 7 and 14 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0.44
Max. score:
2
Reversibility:
fully reversible within: 7d
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0.44
Max. score:
1
Reversibility:
fully reversible within: 7d
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0.44
Max. score:
2
Reversibility:
fully reversible within: 7d
Irritant / corrosive response data:
30 - 60 minutes up to 7 days after application the conjunctivae of the animals showed a diffuse crimson red up to a diffuse beefy red color. Up to three days after application the animals showed sporadically very slight swellings up to swellings with lids about half closed and c1ear-colorless eye discharge. Additionally, hemorrhages at the conjuntivae and nictating membrane were observed up to day 7 of the study. One up to three days after application the cornea of one animal showed diffuse or translucent opacity areas. One and two days after application the iris of this animals was reddened. 14 days after application all signs of irritation were reversible.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information
Conclusions:
Testing of the substance for primary eye irritation in the rabbit showed, that the substance is irritating to eye.
Executive summary:

Testing of the substance for primary eye irritation in the rabbit showed, that the substance is irritating to eye.