Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Only secondary literature available: The study meets basic scientific principles of a Human Repeated Insult Patch Test; primary source is an unpublished report to the RIFM (Research Institute of Fragrance Manufacturers) cited in a BIBRA Toxicity Profile; available data are limited to information on the test protocol and a description of the absence of a sensitizing response

Data source

Reference
Reference Type:
secondary source
Title:
Report to RIFM, 9 June
Author:
Kligman AM
Year:
1971
Bibliographic source:
cited from: BIBRA, Toxicity profile Acetophenone, 1987

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Human repeated insult patch test
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Acetophenone
EC Number:
202-708-7
EC Name:
Acetophenone
Cas Number:
98-86-2
Molecular formula:
C8H8O
IUPAC Name:
1-phenylethanone

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: not specified
- No further data
Clinical history:
no data
Controls:
no data
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Vehicle / solvent: petrolatum
- Concentrations: 2%
- Volume applied: no data
- Testing/scoring schedule:
pretreatment: test site pretreated with mild irritant
induction: five 48-hr closed patches during 10 day period;
challenge: final 48-hr closed patch 10-14 days after termination of the induction phase

- Grading/Scoring system: no data

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: all (number not specified)
- Number of subjects with irritating reactions: no data

Applicant's summary and conclusion

Conclusions:
In a Human Repeated Insult Patch Test, 2% acetophenone in petrolatum did not provoke a sensitizing response in human volunteers.
Executive summary:

In a Human Repeated Insult Patch Test, 2% acetophenone in petrolatum did not provoke a sensitizing response in human volunteers (number not specified). The test protocol consisted of pretreatment of the skin test site with a mild irritant, five 48-hour closed patches during a 10-day induction period followed by 10-14 days without treatment, and a final 48-hour closed patch for challenge.