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Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: Chronic
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 fom WHO

Data source

Reference
Reference Type:
secondary source
Title:
Summary of toxicological data of certain food additives
Author:
WHO
Year:
1977
Bibliographic source:
WHO FOOD ADDITIVES SERIES NO. 12, INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY WORLD HEALTH ORGANIZATION, 18-27 April 1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: Chronic toxicity study
Principles of method if other than guideline:
Chronic repeated dose oral toxicity study of RED 2G in mice.
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
EC Number:
223-098-9
EC Name:
Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
Cas Number:
3734-67-6
Molecular formula:
C18H13N3Na2O8S2
IUPAC Name:
disodium 5-acetamido-4-hydroxy-3-(phenyldiazenyl)naphthalene-2,7-disulfonate
Constituent 2
Reference substance name:
Red 2G
IUPAC Name:
Red 2G
Details on test material:
- Name of test material (as cited in study report): RED 2G
- Molecular formula (if other than submission substance): C16H12N2O4S.Na
- Molecular weight (if other than submission substance): 350.3289 g/mole
- Substance type: Organic
- Physical state: No data available
- Impurities (identity and concentrations): No data available
Specific details on test material used for the study:
- Name of test material (as cited in study report): RED 2G
- Molecular formula (if other than submission substance): C16H12N2O4S.Na
- Molecular weight (if other than submission substance): 350.3289 g/mole
- Substance type: Organic

Test animals

Species:
mouse
Strain:
other: Colworth C57B1
Sex:
male/female
Details on test animals or test system and environmental conditions:
No data available

Administration / exposure

Route of administration:
oral: feed
Type of inhalation exposure (if applicable):
not specified
Vehicle:
other: Diet
Details on exposure:
PREPARATION OF DOSING SOLUTIONS: The test material was mixed in diet.

DIET PREPARATION- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food):
Diet- Storage temperature of food: No data availble

VEHICLE
- Justification for use and choice of vehicle (if other than water): Diet
- Concentration in vehicle: 0, 0.005, 0.025, 0.125 or 0.625%
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available
Details on mating procedure:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
80 weeks
Frequency of treatment:
Daily
Details on study schedule:
not specified
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day
Dose / conc.:
7.5 mg/kg bw/day
Dose / conc.:
37.5 mg/kg bw/day
Dose / conc.:
187.5 mg/kg bw/day
Dose / conc.:
937.5 mg/kg bw/day
No. of animals per sex per dose:
Total: 400 mice
Control: 40 males, 40 females
7.5 mg/kg bw: 40 males, 40 females
37.5 mg/kg bw: 40 males, 40 females
187.5 mg/kg bw: 40 males, 40 females
937.5 mg/kg bw: 40 males, 40 females
Control animals:
yes, concurrent vehicle
Details on study design:
not specified
Positive control:
not specified

Examinations

Parental animals: Observations and examinations:
Survival, clinical sign, body weight, food intake, hematology, clinical chemistry and urine analysis were examined.
Oestrous cyclicity (parental animals):
not specified
Sperm parameters (parental animals):
not specified
Litter observations:
not specified
Postmortem examinations (parental animals):
Organ weight and histopathology were examined.
Postmortem examinations (offspring):
not specified
Statistics:
not specified
Reproductive indices:
not specified
Offspring viability indices:
not specified

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Description (incidence and severity):
No effect on growth of treated mice were observed as compared to control.
Dermal irritation (if dermal study):
not specified
Mortality:
mortality observed, non-treatment-related
Description (incidence):
More than three-quarters of mice survival in all the treated groups.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
No effect on growth of treated mice were observed as compared to control.
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
effects observed, treatment-related
Description (incidence and severity):
Heinz bodies and increased methemoglobin were observed in 187.5 and 937.5 mg/kg bw/day-treated mice.
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
When treated with 187.5 and 937.5 mg/kg bw/day, splenic darkening and enlargement, increased splenic hemosiderin content and accelerated splenic erythropoiesis were observed in treated mice as compared to control.
Histopathological findings: neoplastic:
not specified
Other effects:
not specified

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
not specified
Reproductive function: sperm measures:
not specified
Reproductive performance:
not specified

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
937.5 mg/kg bw/day
Based on:
test mat.
Sex:
male
Basis for effect level:
organ weights and organ / body weight ratios
Remarks on result:
other: No adverse effect on reproductive organ weight.

Target system / organ toxicity (P0)

Critical effects observed:
not specified
System:
other: not specified
Organ:
not specified
Treatment related:
not specified
Dose response relationship:
not specified
Relevant for humans:
not specified

Results: F1 generation

General toxicity (F1)

Clinical signs:
not specified
Dermal irritation (if dermal study):
not specified
Mortality / viability:
not specified
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Sexual maturation:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings:
not specified
Other effects:
not specified

Developmental neurotoxicity (F1)

Behaviour (functional findings):
not specified

Developmental immunotoxicity (F1)

Developmental immunotoxicity:
not specified

Effect levels (F1)

Dose descriptor:
other: not specified
Generation:
other: not specified
Based on:
not specified
Sex:
not specified
Basis for effect level:
other: not specified
Remarks on result:
other: not specified

Target system / organ toxicity (F1)

Critical effects observed:
not specified
System:
other: not specified
Organ:
not specified
Treatment related:
not specified
Dose response relationship:
not specified
Relevant for humans:
not specified

Overall reproductive toxicity

Reproductive effects observed:
not specified
Treatment related:
not specified
Relation to other toxic effects:
not specified
Dose response relationship:
not specified
Relevant for humans:
not specified

Applicant's summary and conclusion

Conclusions:
NOAEL was considered to be 937.5 mg/kg bw for male mice when male and female Colworth C57B1 mice were treated with RED 2G.
Executive summary:

In chronic repeated dose oral toxicity study, male and female Colworth C57B1 mice were treated with RED 2G in the concentration of 0, 7.5, 37.5, 187.5 or 937.5 mg/kg bw/day in feed. No effect on survival or growth of treated mice were observed. Heinz bodies and increased methemoglobin were observed in 187.5 and 937.5 mg/kg bw/day treated mice. No effect on brain, heart, liver, spleen, kidneys or testes weight were observed in treated mice as compared to control. Splenic darkening and enlargement, increased splenic hemosiderin content and accelerated splenic erythropoiesis were observed in treated mice as compared to control, but no effect were observed on testes of male mice. Therefore, NOAEL was considered to be 937.5 mg/kg bw for male mice when male and female Colworth C57B1 mice were treated with RED 2G orally in diet for 80 weeks.