Di-''isononyl'' phthalate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

5.6.1995 to 15.9. 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: A GLP compliant study, using an established test protocol for human clinical investigation (Modified Draize Procedure).

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Reference 2

Reference Type:

publication

Title:

Evaluation of skin sensitization response of dialkyl (C6-C13) phthalate esters.

Author:

Medeiros AM, Devlin DJ, Keller LH.

Year:

1999

Bibliographic source:

Contact Dermatitis. 1999 Nov;41(5):287-9.

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

Modified Draize Procedure. J.H Draize, 'Dermal toxicity' in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (FDA)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich

EC Number:

271-090-9

EC Name:

1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich

Cas Number:

68515-48-0

Molecular formula:

C26 H42 O4

IUPAC Name:

1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich

Constituent 2

Reference substance name:

DINP

IUPAC Name:

DINP

Details on test material:

A transparent , thin liquid supplied to the research facility on 4 May, 1995. No other details reported.

Method

Type of population:

general

Controls:

None

Route of administration:

dermal

Results and discussion

Results of examinations:

No dermal responses were observed from MRD 95-140 during either the preliminary or main human repeated insult patch tests.

Any other information on results incl. tables

No dermal responses were observed from MRD 95-140 during the preliminary or main human patch test studies. The individual scores for the preliminary test and the group total reaction scores for the main test are appended in the 'attached background material' window below.

Applicant's summary and conclusion

Conclusions:

No evidence of clinical sensitisation or irritation was observed in any of the subjects completing the study.

Executive summary:

50% w/w MRD 95-140 (Di-isononyl phthalate) was applied as a 50% w/w preparation in petrolatum under occluded patches, to

the deltoid region of the upper arms of 128 human volunteers for 24 hours, three times a week, during a three week induction period (nine applications), and once, approximately two weeks later, during the challenge. No evidence of clinical sensitisation or irritation was observed in any of the 104 subjects completing the study.

The study is considered acceptable to support classification and risk assessment and satisfies the protocol requirements for human patch test studies.