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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Dermal contact dermatitis from benzylparaben.
Author:
A. TOSTI, P. A. FANTI AND S. PILERJ
Year:
1989
Bibliographic source:
Contact Dermatitis 1989: 21: 49-63

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as per mentioned below
Principles of method if other than guideline:
The patch test performed on woman for the benzylparaben.
GLP compliance:
no
Type of study:
patch test
Justification for non-LLNA method:
Not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzyl 4-hydroxybenzoate
EC Number:
202-311-9
EC Name:
Benzyl 4-hydroxybenzoate
Cas Number:
94-18-8
Molecular formula:
C14H12O3
IUPAC Name:
benzyl 4-hydroxybenzoate
Constituent 2
Reference substance name:
Benzoic acid, 4-hydroxy-, phenyl methyl ester
IUPAC Name:
Benzoic acid, 4-hydroxy-, phenyl methyl ester
Details on test material:
Details on test material
- Name of test material (as cited in study report): Benzylparaben (Synonyms of Benzoic acid, 4-hydroxy-, phenyl methyl ester)
- Molecular formula (if other than submission substance): C14-H12-O3
- Molecular weight (if other than submission substance): 228.2458 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:
human
Strain:
not specified
Sex:
female
Details on test animals and environmental conditions:
Details on test animal
TEST ANIMALS
- Source: No data available
- Age at study initiation: 43 years old
- Weight at study initiation: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available

IN-LIFE DATES: From: To: No data available

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: No data available
Vehicle:
no data
Concentration / amount:
No data available
Challengeopen allclose all
Route:
other: No data available
Vehicle:
no data
Concentration / amount:
No data available
No. of animals per dose:
1 woman
Details on study design:
Details on study design
RANGE FINDING TESTS: No data available

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: No data available
- Test groups: 1
- Control group: No data available
- Site: No data available
- Frequency of applications: 1
- Duration: 72 hrs
- Concentrations: No data available

B. CHALLENGE EXPOSURE
- No. of exposures: No data available
- Day(s) of challenge: No data available
- Exposure period: No data available
- Test groups: No data available
- Control group: No data available
- Site: No data available
- Concentrations: No data available
- Evaluation (hr after challenge): No data available
Challenge controls:
No data available
Positive control substance(s):
not specified

Results and discussion

Positive control results:
No data available

In vivo (non-LLNA)

Results
Reading:
1st reading
No. with + reactions:
1
Total no. in group:
1
Clinical observations:
Woman had a positive reaction. A lymphohistiocytic perivascular infiltrate in the dermis was observe Clinical chemistry: an increased number of Langerhans cells in the dermis and epidermis cells were observed.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. No with. + reactions: 1.0. Total no. in groups: 1.0. Clinical observations: Woman had a positive reaction. A lymphohistiocytic perivascular infiltrate in the dermis was observe Clinical chemistry: an increased number of Langerhans cells in the dermis and epidermis cells were observed. .

Any other information on results incl. tables

other details not known

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The benzylparaben (94-18-8) was found to be sensitizing to woman after patch test.
Executive summary:

A 43 year woman which is already had 3-year history of relapsing nodules and small plaques on her trunk, after 7 years later she again showed multiple nodules and plaques on the trunk and erythema and scaling on the face. Patch test was performed and observed for 72 hrs for paraben mix. Positive reaction was observed for benzylparaben.

Therefore, benzylparaben (94-18-8) was found to be sensitizing to woman after patch test.