Registration Dossier

Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Adequacy of study:
other information

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2013

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers

Method

Subjects:
1532 persons (unspecified)
Route of administration:
dermal
Details on study design:
routine patch test with a phthalate ester mixture (2 % DMP, 2 % DEP and 2 % DBP in petrolatum)

Results and discussion

Results of examinations:
one out of 1532 had a positive reaction

Applicant's summary and conclusion

Conclusions:
One out of 1532 had a positive reaction to a phthalate ester mixture (2 % DMP, 2 % DEP and 2 % DBP in petrolatum).
Executive summary:

In a patch test study (Schulsinger and Mollgaard 1980) with 1532 persons only one showed positive reactions.