Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
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

Reference
Name:
Unnamed
Type:
Constituent
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:
1 x 50 cm3
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

Results
Remarks on result:
probability of severe irritation
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.

Applicant's summary and conclusion

Interpretation of results:
other: Insufficient data to be able to assess classification
Conclusions:
The substance appears to be highly irritating to the eye but the data is not reported in sufficient detail to be able to judge if classification is warranted or not.
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.