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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
Various
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Since potassium benzoate will dissociate under biological conditions, it is considered valid to assess the potential for sensitisation on the properties based on benzoic acid and its soluble salts.

Data source

Reference
Reference Type:
review article or handbook
Title:
OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS
Author:
European Commission
Year:
2002
Bibliographic source:
adopted by the SCCNFP during the 20th plenary meeting of 4 June 2002

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Various clinical studies performed
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
There is sufficient evidence to conclude that this class of substance is not a potential skin sensitiser.No further animal testing can be justified

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzoic acid
EC Number:
200-618-2
EC Name:
Benzoic acid
Cas Number:
65-85-0
Molecular formula:
C7H6O2
IUPAC Name:
benzoic acid
Specific details on test material used for the study:
Not specified

In vivo test system

Test animals

Species:
other: Human
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
Clinical studies

Study design: in vivo (non-LLNA)

Induction
Route:
other: Patch test
Vehicle:
not specified
Concentration / amount:
Various concentrations, up to 5%
Adequacy of induction:
other: Suitable for clinical studies
Challenge
No.:
#1
Route:
other: Patch test
Vehicle:
not specified
Concentration / amount:
Not specified
Adequacy of challenge:
other: Suitable for clinical studies
No. of animals per dose:
In one study, 5302 patients were examined
Details on study design:
Clinical patch tests
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Results
Key result
Reading:
other: Number of readings not specified
Group:
test chemical
No. with + reactions:
34
Total no. in group:
5 203
Clinical observations:
Not recorded
Remarks on result:
other: < 0.7% reaction
Remarks:
Considered negative

Any other information on results incl. tables

Details given in the review document are provided:

Patch test (48 h/occlusive) according to the ICDRG recommendations: 5 % benzoic acid in petrolatum, 627 patients. 8 patients showed positive reactions (1.3% of the tested). Some reactions may be interpreted as allergic but may have been irritant.

25 human volunteers were given five 48 h patch tests (during the 10 d period) with 2 % benzoic acid in petrolatum. None gave positive reactions when challenged 10-14 d after the induction phase by a final 48 h closed patch test with 2 % benzoic acid in petrolatum (only abstract available).

10 persons allergic to benzoyl peroxide were tested by a 48 h patch test with 5 % benzoic acid in a petrolatum. No reactions at 48, 72 and 96 h.

5203 patients with suspected contact dermatitis were patch tested with benzoic acid (no details were given). 34 patients (0.7 %) showed allergic reactions.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The cited clinical studies all concluded negative
Executive summary:

Details given in the review document are provided:

Patch test (48 h/occlusive) according to the ICDRG recommendations: 5 % benzoic acid in petrolatum, 627 patients. 8 patients showed positive reactions (1.3% of the tested). Some reactions may be interpreted as allergic but may have been irritant.

25 human volunteers were given five 48 h patch tests (during the 10 d period) with 2 % benzoic acid in petrolatum. None gave positive reactions when challenged 10-14 d after the induction phase by a final 48 h closed patch test with 2 % benzoic acid in petrolatum (only abstract available).

10 persons allergic to benzoyl peroxide were tested by a 48 h patch test with 5 % benzoic acid in a petrolatum. No reactions at 48, 72 and 96 h.

5203 patients with suspected contact dermatitis were patch tested with benzoic acid (no details were given). 34 patients (0.7 %) showed allergic reactions.