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Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
three-generation reproductive toxicity
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 secondary source

Data source

Reference
Reference Type:
secondary source
Title:
Review of toxicology literature Red dyes (D & C No.27 and D& C No.28)-Year-2000
Author:
NTP
Year:
2000
Bibliographic source:
NTP (National Toxicological Program) by Agency for Toxic Substances and Disease Registry

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: see Principles below
Principles of method if other than guideline:
A three generation reproduction study of D&C Red No. 27 in rats.
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxyspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one
EC Number:
236-747-6
EC Name:
2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxyspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one
Cas Number:
13473-26-2
Molecular formula:
C20H4Br4Cl4O5
IUPAC Name:
2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxy-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material : D & C Red no. 27
- Molecular formula : C20H4Br4Cl4O5
- Molecular weight : 785.6746 g/mol
- Substance type: Organic
- Physical state: Solid
- Purity: No data available
- Impurities (identity and concentrations): No data available
Specific details on test material used for the study:
- Name of test material : D & C Red no. 27
- Molecular formula : C20H4Br4Cl4O5
- Molecular weight : 785.6746 g/mol
- Substance type: Organic
- Physical state: Solid
- Purity: No data available
- Impurities (identity and concentrations): No data available

Test animals

Species:
rat
Strain:
other: CD
Sex:
male/female
Details on test animals or test system and environmental conditions:
Source: Charles River

Administration / exposure

Route of administration:
oral: feed
Type of inhalation exposure (if applicable):
not specified
Vehicle:
other: Feed
Details on exposure:
PREPARATION OF DOSING SOLUTIONS: The test chemical was mixed with feed prior to dosing.
DIET PREPARATION- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available

VEHICLE- Justification for use and choice of vehicle (if other than water):
-Feed- Concentration in vehicle: 0, 5, 50, 150 or 500 mg/kg/day
- Amount of vehicle (if gavage): No data available-
-Lot/batch no. (if required): No data available-
-Purity: No data available
Details on mating procedure:
- M/F ratio per cage: 1:2
- Length of cohabitation: No data available
- Proof of pregnancy: No data available
- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility: No data available
- Further matings after two unsuccessful attempts: No data available
- After successful mating each pregnant female was caged (how): No data available
- Any other deviations from standard protocol: No data available
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Approx 91 days (Test diets were fed to the original parents (F0 generation) two weeks prior to mating and was continued thoughout the study. However, the exact duration of treatment is not mentioned but continued until a F2 generation was produced.)
Frequency of treatment:
Daily
Details on study schedule:
No data available
Doses / concentrations
Remarks:
0, 5, 50, 150 or 500 mg/kg/day
No. of animals per sex per dose:
Total: 150 rats
Control: 10 males, 20 female
5 mg/kg: 10 males, 20 females
50 mg/kg: 10 males, 20 females
150 mg/kg: 10 males, 20 females
500 mg/kg: 10 males, 20 females
Control animals:
yes, concurrent vehicle
Details on study design:
No data available
Positive control:
No data available

Examinations

Parental animals: Observations and examinations:
No data available
Oestrous cyclicity (parental animals):
Fertiliy were observed.
Sperm parameters (parental animals):
No data available
Litter observations:
Pup body weight, litter size and sex composition, viability and survival.
Postmortem examinations (parental animals):
Litter size were observed.
Postmortem examinations (offspring):
Histopathological examinations were also performed on tissues from the F1 and F2 generation.
Statistics:
No data available
Reproductive indices:
No data available
Offspring viability indices:
yes

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
not specified
Dermal irritation (if dermal study):
not specified
Mortality:
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
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Other effects:
not specified

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
no effects observed
Reproductive function: sperm measures:
not specified
Reproductive performance:
no effects observed

Details on results (P0)

No test compound effects were observed on fertility and litter size on treated male and femlae rats.

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
500 other: mg/kg/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
reproductive function (oestrous cycle)
reproductive performance
other: No adverse effects observed.

Target system / organ toxicity (P0)

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

Results: P1 (second parental generation)

General toxicity (P1)

Clinical signs:
not specified
Dermal irritation (if dermal study):
not specified
Mortality:
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
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Other effects:
not specified

Reproductive function / performance (P1)

Reproductive function: oestrous cycle:
no effects observed
Reproductive function: sperm measures:
not specified
Reproductive performance:
no effects observed

Details on results (P1)

No effect on fertility and reproductive performance of treated rats were observed as compared ot contorl.

Effect levels (P1)

Dose descriptor:
NOAEL
Effect level:
500 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
reproductive function (oestrous cycle)
reproductive performance
other: No effect observed

Target system / organ toxicity (P1)

Critical effects observed:
not specified
System:
other: not specified
Organ:
other: 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:
no mortality observed
Body weight and weight changes:
no effects observed
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:
no effects observed
Other effects:
not specified

Developmental neurotoxicity (F1)

Behaviour (functional findings):
not specified

Developmental immunotoxicity (F1)

Developmental immunotoxicity:
not specified

Details on results (F1)

Mortality: No test compound effects were seen on viability and survival.
Body weight: No test compound effects were seen on body weight of pups.
Histopathology: The histopathological examinations showed no treatment-related effects in pups.

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
500 other: mg/kg/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
viability
mortality
body weight and weight gain
histopathology: non-neoplastic
other: No adverse effects observed.

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

Results: F2 generation

General toxicity (F2)

Clinical signs:
not specified
Dermal irritation (if dermal study):
not specified
Mortality / viability:
no mortality observed
Body weight and weight changes:
no effects observed
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:
no effects observed
Other effects:
not specified

Developmental neurotoxicity (F2)

Behaviour (functional findings):
not specified

Developmental immunotoxicity (F2)

Developmental immunotoxicity:
not specified

Details on results (F2)

Mortlity : No test compound effects were seen on viability and survival of pups.
Body weight: No test compound effects were seen on body weight of pups.
Histopathology: The histopathological examinations showed no treatment-related effects of pups.

Effect levels (F2)

Dose descriptor:
NOAEL
Generation:
F2
Effect level:
500 other: mg/kg/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
viability
mortality
body weight and weight gain
histopathology: non-neoplastic
other: No adverse effects observed.

Target system / organ toxicity (F2)

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 500 mg/kg/day for the F0, F1 and F2 generation when CD male and female rats were orally exposed to D&C Red No. 27 during three generations.
Executive summary:

In a multi-generation toxicity study, CD male and female rats were orally exposed to D&C Red No. 27 in diet at a dosage of 0, 5, 50, 150 or 500 mg/kg/day. No effects were observed on body weight of pups, fertility, litter size and sex composition, viability or survival of treated male and female rats. Histopathological examination of tissues from generations F1 and F2 showed no treatment related effects. Therefore, NOAEL was considered to be 500 mg/kg/day for the F0, F1 and F2 generation when CD male and female rats were orally exposed to D&C Red No. 27 during three generations.