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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 from secondary source

Data source

Reference
Reference Type:
secondary source
Title:
Fragrance raw materials monographs for CAS no: 103-82-2
Author:
D.L.J. Opdyke
Year:
1975
Bibliographic source:
Food and Cosmetics Toxicology Volume 13, Issue 6, 1975, Pages 901-902

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Skin sensitization study of Phenylacetic acid was performed by human Maximization test in human
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
No data available

Test material

Constituent 1
Chemical structure
Reference substance name:
Phenylacetic acid
EC Number:
203-148-6
EC Name:
Phenylacetic acid
Cas Number:
103-82-2
Molecular formula:
C8H8O2
IUPAC Name:
phenylacetic acid
Details on test material:
- Name of test material (as cited in study report): Phenylacetic acid
- Molecular formula : C8H8O2
- Molecular weight : 136.149 g/mol
- Substance type: Organic
- Physical state: Solid
- Purity: No data available
- Impurities (identity and concentrations): No data available
Specific details on test material used for the study:
- Name of test material (as cited in study report): Phenylacetic acid
- Molecular formula : C8H8O2
- Molecular weight : 136.149 g/mol
- Substance type: Organic
- Physical state: Solid
- Purity: No data available
- Impurities (identity and concentrations): No data available

In vivo test system

Test animals

Species:
other: Human
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2%
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2%
No. of animals per dose:
25 human volunteers
Details on study design:
No data available
Challenge controls:
No data available
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Statistics:
No data available

Results and discussion

Positive control results:
No data available

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test chemical
Dose level:
2%
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
No skin sensitization reaction was noted
Remarks on result:
no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:
no skin sensitization reaction was noted

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
The skin sensitization test for phenylacetic acid (103-82-2) was considered to be non- sensitizing to humans.

Executive summary:

Skin sensitization test was performed on 25 human volunteers by maximization test at 2% concentration in petrolatum. After observation no skin sensitization reaction was noted. Hence phenylacetic acid (103-82-2) was considered to be non- sensitizing to humans.