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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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
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
Route:
other: No data available
Vehicle:
no data
Concentration / amount:
No data available
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
Positive control results:
No data available
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. .

other details not known

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Skin Sensitization:

 

Various studies were reviewed and the effect of the test compound onSkin sensitization. These are summarized as follows:

 

The benzylparaben (94-18-8) was found to be sensitizing (Dermal contact dermatitis from benzylparaben, 1989) to woman after patch test. 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.

 

The patch test was performed to 50 year old human man as he is developed relapsing tinea of the anagenital region and the neighboring thighs. He was patch tested with the European standard series. After 2 to 3 days of observation positive result was observed for patch test.Therefore, benzylparaben (94-18-8) was found to be sensitizing to human.

 

In Final Report on the Safety Assessment of Benzylparaben, 963. The preliminary tests were conducted using routine patch tests with a mixture comprised of 10% methylparaben, 2% ethylparaben, and 2% propylparaben in equal parts Aquaphor and water.Fifteen cases positive to this mixture [preliminary tests] were assayed for Benzylparaben sensitivity 7/15 were sensitive to both 1 and 5% Benzylparaben solutionsBenzylparaben was found to be sensitizing to eczemateous patients tested for sensitivity to parabens

 

The study report REPORTS of the Scientific Committee on Cosmetology (sixth series), 1987 indicates Benzylparaben was found to be sensitizing to 2 patients of the 4 tested for sensitivity to five parabens.

Among 2000 patients tested in a hospital in a year, 4 were found sensitive to parabens. These 4 patients were tested with each of the 5 parabens, namely methyl, ethyl, propyl, butyl and benzyl. 2 patients were found to react to benzyl paraben.Benzylparaben was found to be sensitizing to 2 patients of the 4 tested for sensitivity to five parabens.

 

According to new CLP regulation classification criteria and based on the values of skin sensitization, it is concluded that the substance benzylparaben (CAS No 94-18-8) is classified for skin sensitization.

Migrated from Short description of key information:

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

Justification for selection of skin sensitisation endpoint:

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

In in-vivo patch-test in human benzylparaben (CAS No 94-18-8) produced sensitization reactions in all humen tested. As per CLP classification, the test material benzylparaben classifies as a skin sensitisation.       

Justification for classification or non-classification

Benzylparaben is classified as a skin sensitisation.