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Toxicological information

Skin sensitisation

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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:
data from handbook or collection of data
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:
Skin sensitization study of Acetophenone (CAS No: 98-86-2) was conducted in 10 guinea pigs to determine its sensitization potential by using Modified DraizeTechnique.
GLP compliance:
not specified
Type of study:
other: Modified DraizeTechnique
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-phenylethan-1-one
Test material form:
liquid
Details on test material:
Name of the test chemical:1-phenylethanone (Acetophenone)
Molecular Formula:C8H8O
Molecular Weigth:120.15 g/mol
Substance Type: Organic
Physical State: Liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Acetophenone
- Molecular formula: C8H8O
- Molecular weight: 120.148 g/mol
- Substance type: Organic
- Physical state: Liquid
-Smiles: c1(ccccc1)C(=O)C
- InChI: 1S/C8H8O/c1-7(9)8-5-3-2-4-6-8/h2-6H,1H3

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: albino Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 350 g
- Housing: Housed in wire mesh cages in pairs of the same sex
- Diet (e.g. ad libitum): Pelleted guinea pig diet, cabbage and hay ad libitum
- Water (e.g. ad libitum): water ad libitum

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
other: Yes suitable vehicle was used. (No detailed information )
Concentration / amount:
Induction concentration: 0.1 mL at 2.5 X 0.25(ICC) : 10 guinea pigs
Day(s)/duration:
No Data Available
Adequacy of induction:
other: The concentration giving slight but perceptible irritation with no oedema was selected as the injection challenge concentration (ICC).
Challengeopen allclose all
No.:
#1
Route:
intradermal and epicutaneous
Vehicle:
other: Yes suitable vehicle was used. (No detailed information )
Concentration / amount:
Challenge concentration: 0.1 mL at 0.25 (ICC) and 20 (ACC): 10 guinea pigs
Day(s)/duration:
24 hours
Adequacy of challenge:
other: The concentration giving slight but perceptible irritation with no oedema was selected as the injection challenge concentration (ICC). The highest concentration which caused no irritation was selected as the application challenge concentration (ACC).
No.:
#2
Route:
intradermal and epicutaneous
Vehicle:
other: Yes suitable vehicle was used. (No detailed information )
Concentration / amount:
Rechallenge concentration: 0.1 mL at 0.25(ICC) and 20 (ACC): 10 guinea pigs
Day(s)/duration:
24 hours
Adequacy of challenge:
other: The concentration giving slight but perceptible irritation with no oedema was selected as the injection challenge concentration (ICC). The highest concentration which caused no irritation was selected as the application challenge concentration (ACC).
No. of animals per dose:
10: 4 males and 6 females or visa versa.
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE: Intradermal
- No. of exposures:4
- Exposure period: No Data Available
- Test groups:10 guinea pigs
- Control group: No Data Available
- Site: 4 sites, 2 auxillary and 2 inguinal lymph nodes
- Frequency of applications:1
- Duration: No Data Available
- Concentrations: 0.1 mL at 2.5 X 0.2.5 (ICC)

B. CHALLENGE EXPOSURE: Intradermal and Epicutaneous
- No. of exposures:1
- Day(s) of challenge: Fourteen days later, challenge test was performed
- Exposure period:24 hours
- Test groups:10guinea pigs
- Control group: No Data Available
- Site: onto the shaved flank in a small circular area
- Concentrations: 0.1 mL at 0.25 (ICC) and 20 (ACC).
- Evaluation (hr after challenge):24 hours

C. RECHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge:7 Days Later , rechalleange test was performed.
- Exposure period: No Data Available
- Test groups:10 animal
- Control group: 4 animal (same sex)
- Site: Intradermally and topically on opposite flanks
- Concentrations: 0.1 mL at 0.25 (ICC) and 20 (ACC).
- Evaluation (hr after challenge): No Data Available
Challenge controls:
At each challenge with controls, 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.
Scoring.

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1 mL at 0.25 (ICC) and 20 (ACC).
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin sensitization was observed at tested concentrations.
Remarks on result:
no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:
No skin sensitization was observed at tested concentrations.

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
No signs of contact sensitization were observed at 0.25% ICC and 20% ACC concentrations. Hence the test material Acetophenone (CAS No: 98-86-2) was considered to be non-sensitizing to the skin of albino Hartley guinea pigs.
Executive summary:

The skin sensitization study ofAcetophenone (CAS No: 98-86-2)was carried out in 10 Inbred Hartley strain albino the guinea pigs of to determine its sensiization potential according modified Draize sensitization test.

 

The preliminary irritation tests were done in guinea pigs to determine concentrations suitable for sensitization testing [injection challenge concentration(ICC) and application challenge concentration(ACC) ]

 

In the induction phase,the total dose was administered on one occasion as 4 intradermal injections, each 2.5 times the ICC (2.5X 0.25). Fourteen days later each animal was challenged intradermally in one flank and topically in the other with 0.1 ml aliquots of test substance at the respective ICC and ACC (0.25 and 20 respectively). Twenty-four hours later the reactions were observed.

 

In the absence of sensitization reactions at first challenge the induction and challenge procedures were repeated, andapparent sensitization reactions confirmed 7 days later by a second challenge with controls included.

 

Based upon the second challenge, it can be concluded that theAcetophenone (CAS No: 98-86-2)was considered to be non-sensitizingto the skin of albino Hartley guinea pigs at 0.25% ICC and 20% ACC concentrations.