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Diss Factsheets

Administrative data

Endpoint:
chronic toxicity: dermal
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:
Skin Painting Studies in Mice on 11 Fd&C and D&C Colors: Fd&C Green no. 3, Red No. 2, Red No. 4, Yellow No. 6, and External D&C No. 7, D&C Orange No. 4, Violet No. 2, Red No. 17, Red No. 34, and Yellow No. 7
Author:
STEVEN CARSON
Year:
1984
Bibliographic source:
Journal of Toxicology: Cutaneous and Ocular Toxicology Volume 3, Issue 3, p. 309-331, 1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Skin painting studies
Principles of method if other than guideline:
Skin painting studies in Swiss Webster mice were carried out.
GLP compliance:
not specified
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt
EC Number:
219-091-5
EC Name:
Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt
Cas Number:
2353-45-9
Molecular formula:
C37H36N2O10S3.2Na
IUPAC Name:
disodium 2-({4-[ethyl(3-sulfonatobenzyl)amino]phenyl}{4-[ethyl(3-sulfonatobenzyl)iminio]cyclohexa-2,5-dien-1-ylidene}methyl)-5-hydroxybenzenesulfonate
Details on test material:
- Name of test material (as cited in study report): FD&C Green NO. 3- Molecular formula: C37H34N2Na2O10S3- Molecular weight: 810.88gm/mol- Substance type: Organic- Physical state: Solid

Test animals

Species:
mouse
Strain:
Swiss Webster
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source:- Age at study initiation:- Weight at study initiation: 17 to 25 g- Fasting period before study: No data available- Housing: All groups were equally divided as to sex. Mice of the same sex were housed five per cage.- Diet (e.g. ad libitum): Purina Laboratory Chow ad libitum- Water (e.g. ad libitum): Fresh- Acclimation period: No data availableENVIRONMENTAL CONDITIONS- Temperature (°C): No data available- Humidity (%):No data available- Air changes (per hr): No data available- Photoperiod (hrs dark / hrs light): No data availableIN-LIFE DATES: From: To: No data available

Administration / exposure

Type of coverage:
not specified
Vehicle:
water
Remarks:
Distilled water
Details on exposure:
TEST SITE- Area of exposure: dorsal area- % coverage: 6 cm2- Type of wrap if used: No data available- Time intervals for shavings or clipplings: according to the rate of hair growth.REMOVAL OF TEST SUBSTANCE- Washing (if done): No data available- Time after start of exposure: No data availableTEST MATERIAL- Amount(s) applied (volume or weight with unit): No data available- Concentration (if solution):0.1 ml - Constant volume or concentration used: yes- For solids, paste formed: Not applicableVEHICLE- Justification for use and choice of vehicle (if other than water): Distilled water was used- Amount(s) applied (volume or weight with unit): No data available- Concentration (if solution): No data available- Lot/batch no. (if required): No data available- Purity: No data availableUSE OF RESTRAINERS FOR PREVENTING INGESTION: No data available
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
19.5 months
Frequency of treatment:
Twice weekly
Doses / concentrations
Remarks:
Doses / Concentrations:1.0 % (1428.5 mg/kg)Basis:no data
No. of animals per sex per dose:
Total: 300 0 % : 100 male, 100 female1.0 % : 50 male, 50 female
Control animals:
yes, concurrent vehicle
Details on study design:
50 mice/ sex/dose were used and 0.1 ml of the test material was applied to the dorsal of each mouse with rubber applicator.Animals that died, those sacrificed moribund and those surviving the 19.5 month experimental period were necropsied and tissues were preserved in 10% formalin.
Positive control:
No data available

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes - Time schedule: Daily - Cage side observations checked in table [No.?] were included: Observations were done to record mortality DETAILED CLINICAL OBSERVATIONS: Yes - Time schedule: Daily DERMAL IRRITATION (if dermal study): No data BODY WEIGHT: Yes, Time schedule for examinations: Daily FOOD CONSUMPTION:- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data availableFOOD EFFICIENCY:- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data availableWATER CONSUMPTION: No data OPHTHALMOSCOPIC EXAMINATION: No data availableHAEMATOLOGY: No data availableCLINICAL CHEMISTRY: No data available URINALYSIS: No data availableNEUROBEHAVIOURAL EXAMINATION: No data availableOTHER: No data available
Sacrifice and pathology:
GROSS PATHOLOGY: Yes Grossly abnormal organs or tissues were observed. HISTOPATHOLOGY: YesOrgans were fixed in 10% formalin solution.Tissues examined.Brain, Pituitary, Thyroid, Thymus, Liver, Spleen, Kidney, Adrenal, Stomach, Small intestines, Large intestines, Urinary bladder, Axillary lymph node, Kidney, ovary, Skin from area of treatment, Any tissue masses and grossly abnormal organs or tissues were examined.
Other examinations:
No data available
Statistics:
No data available

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
No treatment related effect were observed on survival of mice as compared to control. No effect was observed on behavior of treated mice as compared to control.
Dermal irritation:
not specified
Mortality:
no mortality observed
Description (incidence):
No treatment related effect were observed on survival of mice as compared to control. No effect was observed on behavior of treated mice as compared to control.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
High or low body weights observed late in treated group were due to only a few surviving animals which reduced the biological significance of the averages.
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
no effects observed
Description (incidence and severity):
No significant incidence of gross changes was observed in treated mice as compared to control.
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
Malignant lymphoma of liver, Kidneys and Lungs, Myeloid metaplasia of Spleen were observed in treated mice. There was no indication of treatment related changes since most lesions were also evident in the controls.
Histopathological findings: neoplastic:
not specified
Details on results:
The findings described appear to indicate freedom from significant systemic and/or dermal toxic manifestations associated with administrations.

Effect levels

Dose descriptor:
NOAEL
Effect level:
1 428.5 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Survival, Clinical signs, Body weight, Gross pathology and histopathology

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
NOAEL was considered to be 1.0 % (1428.5 mg/kg) when Swiss Webster male and female mice were treated with F D & C Green NO. 3.
Executive summary:
In a Chronic dermal toxicy Study, Swiss Webster male and female mice treated with F D & C Green No. 3, the concentration of 0 and 1.0 % twice weekly. The results shows that F D & C Green NO. 3.was not toxic dermally. No effect was observed on survival and clinical signs of treated mice. High or low body weights observed late in treated group were due to only a few surviving animals which reduced the biological significance of the averages. In addition, No significant incidence of gross changes was observed in treated mice. Malignant lymphoma of liver, Kidneys and Lungs, Myeloid metaplasia of Spleen were observed in treated mice. There was no indication of treatment related changes since most lesions were also evident in the control.

 

Therefore, NOAEL was considered to be 1.0 % (1428.5 mg/kg) when Swiss Webster male and female mice were treated with FD & C Green NO. 3.by dermal application for 19.5 months.