Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically acceptable study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
According to BASF-internal standard, see details in remarks on material and methods.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of the test substance used in the study report: N,N-Diaethyl-aethylendiamin

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: he adjacent eye served as saline control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 50 µL
Duration of treatment / exposure:
Single application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3 hours on the day of treatment and up to 8 days afterwards. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. The report describes findings after 1 and 24 hours and at the end of the observation period.

Results and discussion

In vivo

Results
Irritation parameter:
other: corrosion
Basis:
mean
Time point:
other: within few minutes
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: Reaction observed shortly after instillation.

Any other information on results incl. tables

Already after a few minutes of the test substance instillation, corrosion of the eyes was observed.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

In this acute eye irritation/corrosion study (BASF, 1969), the eyes of 2 Vienna White rabbits were exposed by application of 50 µL undiluted test substance into the conjunctival sac. The animals were observed after 10 min, 1 and 3 hours on the day of treatment and up to 8 days afterwards. The eyes were not washed out after 24 hours. Overall, the treatment caused corrosion of the eye mucous membranes within 1 hour.Thus, the test substance was graded as corrosive under the conditions of this study. This study is classified as acceptable. It satisfies the requirements of OECD test guideline 405.