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Diss Factsheets

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: Article published in established peer-reviewed journal. The Australian NICNAS (National Industrial Chemicals Notification and Assessment Scheme) report on diisobutyl phthalate refers to the cited article in its assessment of the substance.

Data source

Reference
Reference Type:
publication
Title:
A Toxicological Investigation of Some Acute, Short-Term, and Chronic Effects of Administering Di-2-Ethylhexyl Phthalate (DEHP) and Other Phthalate Esters
Author:
Lawrence, W.H., Malik, M., Turner, J.E., Singh, A.R., and Autian, J.
Year:
1975
Bibliographic source:
Journal of Environmental Research, 9, 1-11.

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Ocular Irritation. Method as described by Lawrence et al, 1971. Toxicity of ethylene chlorohydrin. I Acute toxicity studies. J. Pharm. Sci., 60, 568-571.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
di-isobutyl phthalate
IUPAC Name:
di-isobutyl phthalate

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
Doses: Not specified, but di-isobutyl phthalate was tested undiluted at an unknown volume
Duration of treatment / exposure:
48 hrs
Observation period (in vivo):
Observation period:
0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 24 and 48 hours post instillation
Number of animals or in vitro replicates:
Not specified

Results and discussion

In vivo

Results
Irritation parameter:
other: observed irritation
Basis:
other: all animals
Time point:
other: 0.5, 1, 1.5, 2, 2.5, 3, 24 and 48 hrs post instillation
Score:
ca. 0
Reversibility:
not specified
Irritant / corrosive response data:
No grossly observable irritation was reported following instillation of the undiluted substance.

Any other information on results incl. tables

No grossly observable irritation was reported following instillation of the undiluted sample.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No grossly observable irritation was reported following instillation of the undiluted substance.
Executive summary:

No grossly observable irritation was reported following instillation of the undiluted substance.