Iron tris(phosphinate)

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (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 is from peer reviewed journals

Data source

Reference

Reference Type:

publication

Title:

Detection of contact sensitivity of metal salts using the murine local lymph node assay

Author:

Yoshiaki Ikarashi et.al

Year:

1992

Bibliographic source:

Toxicology Letters, 1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: LLNA assay

GLP compliance:

not specified

Type of study:

mouse local lymph node assay (LLNA)

Justification for non-LLNA method:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Ferrous sulfate heptahydrate

EC Number:

616-510-7

Cas Number:

7782-63-0

Molecular formula:

FeSO4.7H2O

IUPAC Name:

Ferrous sulfate heptahydrate

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): Ferrous sulfate heptahydrate
- Molecular formula: FeSO4.7H2O
- Molecular weight: 278.011 g/mol
- Substance type: Inorganic
- Physical State: Solid
- Purchased from: Wako Pure Chemical Industries, Ltd., Osaka, Japan.

In vivo test system

Test animals

Species:

mouse

Strain:

Balb/c

Sex:

female

Details on test animals and environmental conditions:

Details on test animal
TEST ANIMALS
- Source: Japan SLC Inc., Shizuoka, Japan),
- Age at study initiation: 6-8 weeks old
- Weight at study initiation:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:

Study design: in vivo (LLNA)

Vehicle:

dimethyl sulphoxide

Concentration:

25 microliters of 5%DMSO

No. of animals per dose:

3 mice

Details on study design:

TREATMENT PREPARATION AND ADMINISTRATION:
Groups of mice (n=3) were treated with 5% of the test chemical in vehicle or vehicle alone by applying 25 microliters to the dorsum of both ears for three consecutive days. Four days following the initial application, draining lymph nodes were excised. A single cell suspension of LNC was prepared. Incorporation of [3H]TdR was measured, and recorded as mean cpm ± standard deviation (SD) per node of three mice for each group.

Positive control substance(s):

not specified

Statistics:

The incorporation of [3H]TdR was measured using a liquid scintillation counter and expressed as mean counts per
min (cpm) + standard deviation per node of three animals for each test group. Increases in [3H]TdR incorporation relative to vehicle-treated controls were calculated
for each test group and expressed as stimulation indices (SI).

Results and discussion

In vivo (LLNA)

Results

Parameter:

SI

Value:

1.15

Test group / Remarks:

3

Remarks on result:

other: not sensitizing

Cellular proliferation data / Observations:

The SI value of the test chemical, a non-sensitizing metal salt, was 1.15.

Any other information on results incl. tables

THE RESULTS OF LOCAL LYMPH NODE ASSAYS PERFORMED WITH FOUR METAL SALTS

Expt Number	Chemical	[3H]TdR incorporation (mean cpm±SD (x 10-3))	SI
1	DMSO	2.88±0.83	-
	5% test chemical	3.31±0.19	1.15

 

Applicant's summary and conclusion

Interpretation of results:

other: not sensitizing

Conclusions:

The SI value of the test chemical was 1.15. Since the SI value was below 3, EC3 value couldnot be calculated. Hence, the test chemical as considered to be not sensitizing to skin

Executive summary:

LLNA was performed to evaluate the contact sensitivity of the test chemical.

Groups of female BALB/c mice (n=3) were treated with 5% of the test chemical in DMSO or DMSO alone by applying 25 microliters to the dorsum of both ears for three consecutive days. Four days following the initial application, draining lymph nodes were excised. A single cell suspension of LNC was prepared. Incorporation of [3H]TdR was measured, and recorded as mean cpm ± standard deviation (SD) per node of three mice for each group.The incorporation of [3H]TdR was measured using a liquid scintillation counter and expressed as mean counts per

min (cpm) + standard deviation per node of three animals for each test group. Increases in [3H]TdR incorporation relative to vehicle-treated controls were calculated

for each test group and expressed as stimulation indices (SI).

The SI value of the test chemical was 1.15. Since the SI value was below 3, EC3 value couldnot be calculated. Hence, the test chemical was considered to be not sensitizing to skin