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Diss Factsheets

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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995
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

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
IUPAC Name:
bis(7-methyloctyl) phthalate
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.