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Administrative data

Endpoint:
skin 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:
Method as described by Lawrence et al, 1971. Toxicity of ethylene chlorohydrin. I Acute toxicity studies. J. Pharm. Sci., 60, 568-571.
Treatment of data: For determining the TIC-4 value, 10 responses for each concentration were obtained, scored, and converted to an 8-point scale (i.e., 3+ = 8; 2+ = 6; I+ = 4; ± = 2; 0 = 0) for graphic determination by the method of Luduena and Hoppe (1952).
TIC-4 represents a graphic solution based upon 10 observations of three or more dilutions of the phthalate in cottonseed oil. The TIC-4 value provokes a mild but distinct irritant reaction. When the undiluted phthalate failed to produce a degree of irritation equivalent to that for TIC-4, it was recorded as >100%.
GLP compliance:
not specified

Test material

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

Test animals

Species:
mouse
Strain:
ICR

Test system

Type of coverage:
other: Intradermal
Preparation of test site:
not specified
Vehicle:
other: Cottonseed oil
Controls:
yes, concurrent vehicle
Amount / concentration applied:
Not specified, but DIBP was also tested undiluted at an unknown injection volume
Duration of treatment / exposure:
Not specified
Observation period:
Not specified
Number of animals:
Groups of 10 males

Results and discussion

In vivo

Results
Irritation parameter:
other: TIC-4 responses
Remarks on result:
other: No evidence of irritation equivalent to that for TIC-4. Method of Luduena and Hoppe (1952)
Irritant / corrosive response data:
The TIC-4 for di-isobutyl phthalate was >100%, indicating that it did not produce any distinct irritant reaction, even when administered undiluted.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The TIC-4 for di-isobutyl phthalate was >100%, indicating that it did not produce any distinct irritant reaction, even when administered undiluted.
Executive summary:

The TIC-4 for di-isobutyl phthalate was >100%, indicating that it did not produce any distinct irritant reaction, even when administered undiluted.