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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from publication .

Data source

Reference
Reference Type:
publication
Title:
The sensitization potential of some perfume ingredients tested using a modified draize procedure.
Author:
D.W. SHARP
Year:
1978
Bibliographic source:
Toxicology, 9 (1978) 261-271

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
To evalute the skin sensitizing potential of 1-phenylethanone in male and female Hartley Guinea pigs.
GLP compliance:
not specified
Type of study:
Draize test
Justification for non-LLNA method:
not specified

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
Test material form:
liquid
Details on test material:
- Name of test material: acetophenone
- IUPAC name: 1Phenylethanone
- Molecular formula: C8H8O
- Molecular weight: 120.1502 g/mole
- Smiles notation: c1(ccccc1)C(=O)C
- InChl: 1S/C8H8O/c1-7(9)8-5-3-2-4-6-8/h2-6H,1H3
- Substance type: Organic
- Physical state: Liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 1-phenylethanone
- Molecular formula (if other than submission substance): C8H8O
- Molecular weight (if other than submission substance): 120.148 g/mol
- Substance type: Organic
- Physical state: Liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Details on test animal
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 350 g
- Housing: wire mesh cages in pairs of the same sex
- Diet (e.g. ad libitum): pelleted guinea pig diet, cabbage, hay.
- Water (e.g. ad libitum): water ad libitum

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
not specified
Concentration / amount:
No data
Challenge
Route:
intradermal and epicutaneous
Vehicle:
not specified
Concentration / amount:
Intradermal injection challenge concentration (ICC): 0.25 %
Topical application challenge concentration (ACC): 20 %
Day(s)/duration:
24 hour
No. of animals per dose:
10 animals
Either 4 males and 6 females or visa versa
Challenge controls:
Yes
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Statistics:
No data available.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
20 %(ACC), 0.25%(ICC)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No sensitization reaction were observed
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
20 %(ACC), 0.25%(ICC)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No sensitization reaction were observed
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: • not sensitizing
Conclusions:
Acetophenone observed to be non-sensitizing when treated with Hartley guinea pigs ay different conscemtration.
Executive summary:

Acetophenone (98 -86-2) was tested in modified Draize test with groups of 10 male and female Hartley guinea pigs. For induction treatment, 0.1 ml aliquots of the test substance at 2.5 times the injection challenge concentration (ICC) were administered on one occasion as 4 intradermal injections at 4 sites which overlied the 2 auxilary and 2 inguinal lymph nodes. After an induction time of 14 days, the challenge treatment consisted of an intradermal injection in one flank and topical application (uncovered) on the other flank with an application challenge concentration (ACC) of 20 %. Reactions were scored 24 hrs later. In the absence of sensitization reactions at first challenge, the induction and challenge procedures were repeated, but this time a confirmatory challenge with controls was included. At each challenge 4 previously untreated animals of the same sex and similar weight to the test animals were treated intradermally and topically on opposite flanks with 0.1 ml aliquots of test substance at the ICC and ACC, respectively.No sensitization reaction were observed,Acetophenone (98 -86-2) was assessed as non-sensitizing.