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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
data from handbook or collection of data
Justification for type of information:
Since lithium benzoate will dissociate under biological conditions, it is considered valid to assess the potential for sensitisation on the properties of other lithium salts and on benzoic acid and its soluble salts.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
no guideline available
Version / remarks:
Various methods used to test this class of substance
Principles of method if other than guideline:
Lithium salts, benzoic acid and benzoate salts have been extensively reviewed for medical and cosmetic use.There is no evidence from human trials or animal studies of sensitisation potential
GLP compliance:
no
Type of study:
other: Various methods, including human patch tests
Justification for non-LLNA method:
New animal testing is not considered appropriate.

Test material

Constituent 1
Chemical structure
Reference substance name:
Lithium benzoate
EC Number:
209-042-6
EC Name:
Lithium benzoate
Cas Number:
553-54-8
Molecular formula:
C7H6O2.Li
IUPAC Name:
lithium benzoate
Specific details on test material used for the study:
Lithium benzoate has been assessed on the basis of work conducted on lithium salts and on benzoic acid and its salts.

In vivo test system

Test animals

Species:
other: Many human studies included
Strain:
not specified
Sex:
male/female

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
not specified
Concentration / amount:
Not specified
Day(s)/duration:
Not specified
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, open
Vehicle:
not specified
Concentration / amount:
Not specified - applied to intact skin
Adequacy of challenge:
not specified

Results and discussion

In vivo (non-LLNA)

Results
Key result
Reading:
other: Not specified
Group:
test chemical
Dose level:
Not specified
No. with + reactions:
0
Clinical observations:
Not specified - none reported
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Assessed as negative.New animal testing is not warranted.
Executive summary:

Since lithium benzoate will dissociate under biological conditions, it is considered valid to assess the potential for sensitisation on the properties of other lithium salts and on benzoic acid and its soluble salts. Benzoates and benzoic acid is widely used in cosmetics and there is no evidence that this chemical types results in any immune response leading to sensitisation to skin or respiratory system. However, limited animal data is available and some of the Governmental revues performed on benzoates and benzoic acid rely on human trials to make conclusions that there is no potential for sensitisation. There is a similar absence of primary data for lithium salts. Many common lithium salts are irritant or corrosive to skin (alkaline) and the most widely used salt for consumer use is carbonate; however, almost all data found for the carbonate is based on oral exposure as there are no therapeutic uses from dermal administration.