Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early study report; short study description, otherwise scientifically acceptable

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
Report date:
1966

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
BASF-internal standard
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2-(2-butoxyethoxy)ethoxy)ethanol
EC Number:
205-592-6
EC Name:
2-(2-(2-butoxyethoxy)ethoxy)ethanol
Cas Number:
143-22-6
Molecular formula:
CH3(CH2)3(OCH2CH2)3OH
IUPAC Name:
2-[2-(2-butoxyethoxy)ethoxy]ethanol
Details on test material:
no data

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
50 µl
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
both animals
Time point:
other: 24-72 h
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: not reversible in one animal
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 72 h - 8 d
Reversibility:
not fully reversible within:
Remarks on result:
other: iritis was observed from day 3 onwards
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
both animals
Time point:
other: 24-72 h
Score:
1.3
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: not reversible in both animals
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
both animals
Time point:
other: 24-72 h
Score:
0.45
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
Severe redness, edema and opacity were noted after 1 hour of treatment.
These conditions persisted for 8 days. After 8 days, scars were visible (eyelid vessels were considerably injected). Eye signs (redness, edema, opacity and scar) were scored from slight to very severe.
One animal developed iritis from day 3 onwards (no scores indicated)

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information
Conclusions:
The substance appears to be highly irritating to the eye and persists at least until day 8 after treatment
Executive summary:

In an old eye irritation study in rabbits for which only basic results are available, 2-(2-(2-butoxyethoxy)ethoxy)ethanol produced severe redness, edema and opacity which persisted for 8 days. After 8 days, scars were visible (eyelid vessels were considerably injected). Eye signs (redness, edema, opacity and scar) were scored from slight to very severe. These high scores suggest that the immediate acute response was probably strong enough to warrant classification as a severe eye irritant (R41 or H318), although the available data is not sufficiently detailed to enable this to be unequivocally determined.