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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is rated a "2" because appropriate testing methods were used; however, the study predates GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
Concentration: 0.1 undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
4 days
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-48 hours
Score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-48 h
Score:
0
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Conclusions:
Under the conditions of this study, the test substance was considered minimally irritating.
Executive summary:

In a study conducted in 6 rabbits, undiluted DIDP produced only slight signs of irritation in the conjunctiva at 1, 4 and 24-hour observation time (redness score 1 or 2 and discharge at 1 hour, redness score 1 at 4 hours and redness score 1 in 1 animal at 24 hours). All the eyes were normal at 48, 72 and 96 hours.