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Diss Factsheets

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
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
The open epicutaneous test (OET), a predictive test procedure in the guinea pig for estimation of allergenic properties of simple chemical compounds, their mixtures and of finished cosmetic preparations
Author:
Klecak G
Year:
1979
Bibliographic source:
International Federation Societies Cosmetic Chemists, 9/18/79

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Open Epicutaneous Test
Deviations:
not applicable
Principles of method if other than guideline:
Modified non-occlusive Draize skin sensitsation test with one ocassion for induction (4 intradermal injections of 0.1 mL aliquots at 2.5-fold concentration of ICC)
GLP compliance:
no
Type of study:
Draize test
Justification for non-LLNA method:
Test performed 1979.

Test material

Constituent 1
Chemical structure
Reference substance name:
4'-methoxyacetophenone
EC Number:
202-815-9
EC Name:
4'-methoxyacetophenone
Cas Number:
100-06-1
Molecular formula:
C9H10O2
IUPAC Name:
1-(4-methoxyphenyl)ethanone

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
Not specified.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
not specified
Concentration / amount:
100, 30, 10, 3 and 1% or lower
Day(s)/duration:
Not specified
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, open
Vehicle:
not specified
Concentration / amount:
Not specified
Day(s)/duration:
Not specified
Adequacy of challenge:
not specified
No. of animals per dose:
Not specified.
Details on study design:
PRELIMINARY STUDY
- Type of study: Irritation test
- Obejctive: To determine the animal irritating concentration and to derive the maximal non-irritant concentration (the highest concentration not inducing macroscopic signs of irritation in any of the animals in the specific test group) as baseline data for the main test
- Concentrations: 4 different concentrations
- Vehicle: Not specified
- Test groups: 1 group of test animals per concentration
- Application site: Left flank skin, skin clipped
- Occlusion: None (non-occlusive)
- Exposure: 24 hours
- Reading: After 24 hours

MAIN TEST
- Phases of the test procedure: Induction (21 daily open applications), challenge (on days 21 and 35)
- Concentrations: 100, 30, 10, 3 and 1% or lower
- Vehicle: Ethanol, acetone, water, vaseline, PEG and/or other suitable vehicles; not further specified
- Application site: Left flank skin, skin clipped
- Occlusion: None (non-occlusive)
- Exposure: Not specified
- Reading: Not specified
Challenge controls:
Yes, one control group with 8 test animals.
Positive control substance(s):
no

Results and discussion

Positive control results:
Not applicable.

In vivo (non-LLNA)

Resultsopen allclose all
Group:
negative control
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
not measured/tested
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
6%
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
Not specified
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
6%
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
Not specified
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
6%
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
Not specified
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

The results of the Open Epicutaneous Test (OET) were compared with those of the Kligman Human Maximization Test (HMT) by RIFM. The results of the OET coincided with those of the HMT: At a test concentration of 6.0% (purity of the test material >= 97%) no signs skin sensitisation was oberved.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item has no skin sensitising potential in an OET with guinea pigs.
Executive summary:

An open epicutaneous test was conducted in guinea pigs. Induction consisted of 21 daily open applications to the shaved flank of 6-8 guinea pigs per group. One to six experimental and one control group was used. Open challenge applications were made on days 21 and 35. Reactions were read at 24, 48 and 72 hours. No further details were provided.