Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

NOAEL was considered to be 1000 mg/kg/day for F0 generation and F1 generation whenCharies river CD®male and female rat were exposed todisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate orally in feed.

Link to relevant study records
Reference
Endpoint:
reproductive toxicity, other
Remarks:
Chronic toxicity and carcinogenicity
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from NTRL report
Qualifier:
equivalent or similar to guideline
Guideline:
other: as below
Principles of method if other than guideline:
Chronic toxicity and carcinogenicity study of D&C Red #6 in rat
GLP compliance:
not specified
Limit test:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report):Ldisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate/ Lithol Rubine B - Molecular formula (if other than submission substance):C18H14N2O6S.2Na- Molecular weight (if other than submission substance):432.38 g/mole- Substance type:Organic
Species:
rat
Strain:
other: Charies river CD®
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Source: Charies river Breeding Laboratories. Iac. Wilningeon - Age at study initiation: (P) x wks; (F1) x wks: P: 36 days- Weight at study initiation: (P) Males: 75-155 g, Female: 75-114 g- Fasting period before study: No data available - Housing: Animals were housed individually in hanging wire mash cages. - Diet (e.g. ad libitum): Purina Laboratory diet, ad libitum. During post weaning segment Purina Laboratory diet, Rodent Laboratory Chow@#5001 and Certified Rodent Chow were used respectively. - Water (e.g. ad libitum): Tap water, ad libitum- Acclimation period: 15 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 71 °- Humidity (%): 53 %- Air changes (per hr): No data available - Photoperiod (hrs dark / hrs light): 12 hr light/12hr dark
Route of administration:
oral: feed
Type of inhalation exposure (if applicable):
not specified
Vehicle:
other: Purina Laboratory diet
Details on mating procedure:
- M/F ratio per cage: 1:1 ratio - Length of cohabitation:7 days - Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancySperm and /or copulatory plug observed in the following morning were considered to be Day 0 of gestation. - 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 / yes (explain)] No data available- After successful mating each pregnant female was caged (how):Individually - Any other deviations from standard protocol:No data available
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
126 week
Frequency of treatment:
Daily
Details on study schedule:
not specified
Remarks:
0,0, 25, 150, or 1000 mg/kg bw/day
No. of animals per sex per dose:
Total : 1300F0 generation 0 mg/kg body weight/day: 60 male, 60 Female 0 mg/kg body weight/day: 60 male, 60 Female 25 mg/kg body weight/day: 60 male, 60 Female 150 mg/kg body weight/day: 60 male, 60 Female 1000 mg/kg body weight/day: 60 male, 60 Female F1 generation 0 mg/kg body weight/day: 70 male, 70 Female 0 mg/kg body weight/day: 70 male, 70 Female 25 mg/kg body weight/day: 70 male, 70 Female 150 mg/kg body weight/day: 70 male, 70 Female 1000 mg/kg body weight/day: 70 male, 70 Female
Control animals:
yes, concurrent vehicle
Details on study design:
not specified
Positive control:
not specified
Parental animals: Observations and examinations:
Mortality , clinical sign, body weight, food and compound consumption, ophthalmoscopic examination, haematology, clinical chemistry, urinalysis, virology and microbiology were observed
Oestrous cyclicity (parental animals):
Any irregularities in the estrous cycle were investigated
Sperm parameters (parental animals):
not specified
Litter observations:
Live birth, sex, survival, body weigh, food and compound consumption, ophthalmoscopic examination, haematology, clinical chemistry, urinalysis, virology and microbiology were observed
Postmortem examinations (parental animals):
Gross abnormalities and organ weight were examined.
Postmortem examinations (offspring):
Gross abnormalities, organ weight and histopathology were examined.
Statistics:
Statistically analysis were performed by using fertility indices, gestation 4, 14 and 21 day survival indices were compared by using Chi- square test and /or Fishur’s extract probability. The mean number of liveborn pups per litter and the litter mean per weight at day 0,4,14 and 21 were compared by analysis of variance (one way classification), Barletts test for homogenicty of variances and the appropriate t-test (for equal and unequal variances).For F1 rat: all pair wise statistical comparison were two tailed with the probability level for significance at 0.01. Body weight, food consumption and absolute and relative body weight were compared by analysis of variances and appropriate t-test. Data for animals with malignant tumors, with beings and all tumors combined were analyzed separately by sex. Homogenicity was analysed by cor’s test and cehan-Breslow generalized Krunkal-Wallis test. For the histopathologically proired neoplastic lesions incidencus the two control groups were tested against each other.
Reproductive indices:
Fertility index, gestation index and effect on parturition and lactation were examined.
Offspring viability indices:
Yes, on day 0, 4 and 14
Clinical signs:
not specified
Dermal irritation (if dermal study):
not specified
Mortality:
no mortality observed
Description (incidence):
When treated with 150 mg/kg bw, 3 rats were died.When reated with 1000 mg/kg bw one rat died and in control 3 rats were died.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
No effect on body weight of treated rat was observed as comparable to control.
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
No effect on food consumption of treated male and female rats was observed as comparable to control.
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
no effects observed
Description (incidence and severity):
No change in treated male and female rats was observed as compared to control.
Haematological findings:
no effects observed
Description (incidence and severity):
No change in treated male and female rats was observed as compared to control.
Clinical biochemistry findings:
no effects observed
Description (incidence and severity):
No effect on Clinical chemistry of treated male and female rats was observed as compared to control.
Urinalysis findings:
no effects observed
Description (incidence and severity):
No effect on urinalysis of treated male and female rats was observed as compared to control.
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
An acceleration of testicular changes (degeneration of the testicular tubules) was observed in treated male rat, a common effect in ageing rats. However, at the termination of the study, the increased incidence was not of statistical significance.
Histopathological findings: neoplastic:
not specified
Other effects:
no effects observed
Description (incidence and severity):
Virology:No effect on virology of treated male and female rats was observed as compared to control.Microbiology:No effect on Microbiology of treated male and female rats was observed as compared to control.
Reproductive function: oestrous cycle:
not specified
Reproductive function: sperm measures:
not specified
Reproductive performance:
no effects observed
Description (incidence and severity):
No effect on Fertility index, gestation index and effect on parturition and lactation were observed as compared to control.
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Remarks on result:
other: No effect observed
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
Clinical signs:
not specified
Dermal irritation (if dermal study):
not specified
Mortality / viability:
no mortality observed
Description (incidence and severity):
No effect on survival of F1 offspring were observed as compared to control.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
When treated with 1000 mg/kg bw, significant decrease in body weight were observed in male rat as comparable to control. When treated with 25 and 150 mg/kg bw, slightly decreased body weight was observed as comparable to control. Decrease in body weight were recovred in treated rats.
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
No effect on food consumption of treated male and female offspring’s was observed as comparable to control.
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
no effects observed
Description (incidence and severity):
No change in treated male and female offsprings rats was observed as compared to control.
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:
no effects observed
Description (incidence and severity):
No effect on organ weight of treated male and female offspring was observed as compared to control.
Gross pathological findings:
no effects observed
Description (incidence and severity):
No gross pathological changes were observed in treated male and female offspring as compared to control.
Histopathological findings:
no effects observed
Description (incidence and severity):
An acceleration of testicular changes (degeneration of the testicular tubules) was observed in treated male rat, a common effect in ageing rats. However, at the termination of the study, the increased incidence was not of statistical significance.
Other effects:
not specified
Behaviour (functional findings):
not specified
Developmental immunotoxicity:
not specified
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
viability
mortality
body weight and weight gain
food consumption and compound intake
ophthalmological examination
haematology
clinical biochemistry
urinalysis
organ weights and organ / body weight ratios
gross pathology
neuropathology
other: No effect observed
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
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
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
Behaviour (functional findings):
not specified
Developmental immunotoxicity:
not specified
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
Conclusions:
NOAEL was considered to be 1000 mg/kg/day for F0 generation and F1 geneartion when Charies river CD®male and female rat were exposed to disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate orally in feed.
Executive summary:

In achronic toxicity and carcinogenicitystudy,Charies river CD®male and femalerat were exposedtodisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate in the concentration 0, 0, 25, 150 and 1000 mg/kg/day orally in feed. In the parental generation,3 rats were died at 150 mg/kg bw, one rat died at 1000 mg/kg bw and 3 rats were died in in control. No effect onbody weight andfood consumption,ophthalmoscopic examination, haematology, clinical chemistry, urinalysis, virology and microbiologyof treated male and female rats was observed as comparable to control.Similarly, No effect on reproductive performance such asFertilityindex, gestation index and effect on parturition and lactation were observed as compared to control. No effect onorgan weight and gross pathology were observed as compared to control in P and F1 generation. In addition, anacceleration of testicular changes (degeneration of the testicular tubules) was observed in treated male rat, a common effect in ageing rats. However, at the termination of the study, the increased incidence was not of statistical significance. Therefore, NOAEL was considered to be 1000 mg/kg/day for F0 generation and F1 geneartion whenCharies river CD®male and female rat were exposed todisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate orally in feed.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
chronic
Species:
rat
Quality of whole database:
Dats is Klimisch 4 and from NTRL and COLIPA
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Reproductive toxicity: Oral

In different studies, disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate has been investigated for Reproductive toxicity to a greater or lesser extent. Often are the studies based on in vivo experiments and estimated data in rodents, i.e. most commonly in rats and mice for disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate along with the study available on structurally similar read across substance Carmoisine (CAS: 3567-69-9). The predicted data using the OECD QSAR toolbox has also been compared with the experimental studies.

In a experimental study given by Environmental Protection Agency, Washington, DC. Office of Toxic (National Technical Reports Library, NTRL, 1992) and Scientific Committee on Cosmetic Products (COLIPA, SCCNFP, 2004),Charies river CD®male and femalerat were exposed todisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate in the concentration 0, 0, 25, 150 and 1000 mg/kg/day orally in feed. In the parental generation,3 rats were died at 150 mg/kg bw, one rat died at 1000 mg/kg bw and 3 rats were died in in control. No effect onbody weight andfood consumption,ophthalmoscopic examination, haematology, clinical chemistry, urinalysis, virology and microbiologyof treated male and female rats was observed as comparable to control.Similarly, No effect on reproductive performance such as Fertilityindex, gestation index and effect on parturition and lactation were observed as compared to control. No effect onorgan weight and gross pathology were observed as compared to control in P and F1 generation. In addition, anacceleration of testicular changes (degeneration of the testicular tubules) was observed in treated male rat, a common effect in ageing rats. However, at the termination of the study, the increased incidence was not of statistical significance. Therefore,  NOAEL was considered to be 1000 mg/kg/day for F0 generation and F1 generation whenCharies river CD®male and female rat were exposed todisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate orally in feed.

In another experimental study conducted by Environmental Protection Agency, Washington, DC. Office of Toxic (National Technical Reports Library, NTRL, 1992) and Scientific Committee on Cosmetic Products (COLIPA, SCCNFP, 2004),In a long term toxicity study, CD male and female mice were exposed to disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate in the concentration 0 ,0, 75, 1500 and 7500 mg/kg bw/day orally in feed. Slight compound related increase in mortality was observed in male mice during last 6 months of study at 7500 mg/kg bw. Hair and exposed sikn area appered red, a reddish brown ventral abdomen and/or anogenital region was observed readdish brown in colour at 1500 and 7500 mg/kg bw and anogenital region was observed orang in coloure at 75 mg/kg bw. No effect on body weight and food consumption of treated mice was observed as comparable to control. Similarly, No effect on reproductive organ weight and gross pathology of treated male and female mice was observed as compared to control. Revealed degenerative kidney changes were observed in 7500 mg/kg bw treated male mice. Therefore, NOAEL was considered to be 1500 mg/kg/day for male and 7500 mg/kg bw when CD male and female rat were exposed to disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate orally in feed.

Thus, based on the above studies on disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate, it can be concluded that NOAEL value is1000 mg/kg/day. Thus, comparing this value with the criteria of CLP regulation, disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate can be Not classified for reproductive toxicity.

Effects on developmental toxicity

Description of key information

NOAEL was considered to be 1000 mg/kg/day for F0 generation and F1 generation whenCharies river CD®male and female rat were exposed todisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate orally in feed.

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from NTRL report
Qualifier:
according to guideline
Guideline:
other: as below
Principles of method if other than guideline:
Chronic toxicity and carcinogenicity study of D&C Red #6 in rat
GLP compliance:
not specified
Limit test:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report):Ldisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate/ Lithol Rubine B - Molecular formula (if other than submission substance):C18H14N2O6S.2Na- Molecular weight (if other than submission substance):432.38 g/mole- Substance type:Organic
Species:
rat
Strain:
other: Charies river CD®
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: Charies river Breeding Laboratories. Iac. Wilningeon - Age at study initiation: (P) x wks; (F1) x wks: P: 36 days- Weight at study initiation: (P) Males: 75-155 g, Female: 75-114 g- Fasting period before study: No data available - Housing: Animals were housed individually in hanging wire mash cages. - Diet (e.g. ad libitum): Purina Laboratory diet, ad libitum. During post weaning segment Purina Laboratory diet, Rodent Laboratory Chow@#5001 and Certified Rodent Chow were used respectively. - Water (e.g. ad libitum): Tap water, ad libitum- Acclimation period: 15 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 71 °- Humidity (%): 53 %- Air changes (per hr): No data available - Photoperiod (hrs dark / hrs light): 12 hr light/12hr dark
Route of administration:
oral: feed
Type of inhalation exposure (if applicable):
not specified
Vehicle:
other: Purina Laboratory diet
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
- M/F ratio per cage: 1:1 ratio - Length of cohabitation:7 days - Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancySperm and /or copulatory plug observed in the following morning were considered to be Day 0 of gestation. - 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 / yes (explain)] No data available- After successful mating each pregnant female was caged (how):Individually - Any other deviations from standard protocol:No data available
Duration of treatment / exposure:
126 week
Frequency of treatment:
Daily
Duration of test:
126 week
Remarks:
0,0, 25, 150, or 1000 mg/kg bw/day
No. of animals per sex per dose:
Total : 1300F0 generation 0 mg/kg body weight/day: 60 male, 60 Female 0 mg/kg body weight/day: 60 male, 60 Female 25 mg/kg body weight/day: 60 male, 60 Female 150 mg/kg body weight/day: 60 male, 60 Female 1000 mg/kg body weight/day: 60 male, 60 Female F1 generation 0 mg/kg body weight/day: 70 male, 70 Female 0 mg/kg body weight/day: 70 male, 70 Female 25 mg/kg body weight/day: 70 male, 70 Female 150 mg/kg body weight/day: 70 male, 70 Female 1000 mg/kg body weight/day: 70 male, 70 Female
Control animals:
yes, concurrent vehicle
Maternal examinations:
Mortality, clinical sign, body weight, food and compound consumption, ophthalmoscopic examination, haematology, clinical chemistry, urinalysis, virology, microbiology, Gross abnormalities and organ weight were examined.
Ovaries and uterine content:
not specified
Fetal examinations:
Live birth, sex, survival, body weigh, food and compound consumption, ophthalmoscopic examination, haematology, clinical chemistry, urinalysis, virology, microbiology, Gross abnormalities, organ weight and
Statistics:
Statistically analysis were performed by using fertility indices, gestation 4, 14 and 21 day survival indices were compared by using Chi- square test and /or Fishur’s extract probability. The mean number of liveborn pups per litter and the litter mean per weight at day 0,4,14 and 21 were compared by analysis of variance (one way classification), Barletts test for homogenicty of variances and the appropriate t-test (for equal and unequal variances).For F1 rat: all pair wise statistical comparison were two tailed with the probability level for significance at 0.01. Body weight, food consumption and absolute and relative body weight were compared by analysis of variances and appropriate t-test. Data for animals with malignant tumors, with beings and all tumors combined were analyzed separately by sex. Homogenicity was analysed by cor’s test and cehan-Breslow generalized Krunkal-Wallis test. For the histopathologically proired neoplastic lesions incidencus the two control groups were tested against each other.
Indices:
Fertility index, gestation index and effect on parturition and lactation were examined.
Clinical signs:
not specified
Dermal irritation (if dermal study):
not specified
Mortality:
no mortality observed
Description (incidence):
When treated with 150 mg/kg bw, 3 rats were died.When reated with 1000 mg/kg bw one rat died and in control 3 rats were died.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
No effect on body weight of treated rat was observed as comparable to control.
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
No effect on food consumption of treated male and female rats was observed as comparable to control.
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
no effects observed
Description (incidence and severity):
No change in treated male and female rats was observed as compared to control.
Haematological findings:
no effects observed
Description (incidence and severity):
No change in treated male and female rats was observed as compared to control.
Clinical biochemistry findings:
no effects observed
Description (incidence and severity):
No effect on Clinical chemistry of treated male and female rats was observed as compared to control.
Urinalysis findings:
no effects observed
Description (incidence and severity):
No effect on urinalysis of treated male and female rats was observed as compared to control.
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
No effect on organ weight of treated male and female rats was observed as compared to control.
Gross pathological findings:
no effects observed
Description (incidence and severity):
No gross pathological changes were observed in treated male and female rats as compared to control.
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Description (incidence and severity):
An acceleration of testicular changes (degeneration of the testicular tubules) was observed in treated male rat, a common effect in ageing rats. However, at the termination of the study, the increased incidence was not of statistical significance.
Histopathological findings: neoplastic:
not specified
Other effects:
no effects observed
Description (incidence and severity):
Virology:No effect on virology of treated male and female rats was observed as compared to control.Microbiology:No effect on Microbiology of treated male and female rats was observed as compared to control.
Number of abortions:
not specified
Pre- and post-implantation loss:
not specified
Total litter losses by resorption:
not specified
Early or late resorptions:
not specified
Dead fetuses:
not specified
Changes in pregnancy duration:
not specified
Description (incidence and severity):
Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not specified
Changes in number of pregnant:
not specified
Other effects:
not specified
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
body weight and weight gain
clinical biochemistry
food consumption and compound intake
gross pathology
haematology
histopathology: non-neoplastic
mortality
ophthalmological examination
organ weights and organ / body weight ratios
urinalysis
other: No effect observed
Abnormalities:
not specified
Localisation:
not specified
Description (incidence and severity):
not specified
Fetal body weight changes:
not specified
Description (incidence and severity):
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed
Field "Description (incidence and severity)" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.DescriptionIncidenceAndSeverityFetalPupBodyWeightChanges): When treated with 1000 mg/kg bw, significant decrease in body weight were observed in male rat as comparable to control. When treated with 25 and 150 mg/kg bw, slightly decreased body weight was observed as
Reduction in number of live offspring:
no effects observed
Changes in sex ratio:
not specified
Changes in litter size and weights:
not specified
Changes in postnatal survival:
no effects observed
Description (incidence and severity):
No effect on survival of F1 offspring were observed as compared to control.
Skeletal malformations:
not specified
Visceral malformations:
not specified
Other effects:
no effects observed
Description (incidence and severity):
Food consumption: No effect on food consumption of treated male and female offspring’s was observed as comparable to control.Opthalmology:No change in treated male and female offsprings rats was observed as compared to control.Organ weights:No effect on organ weight of treated male and female offspring was observed as compared to control. Gross pathology:No gross pathological changes were observed in treated male and female offspring as compared to controlHistopathology:An acceleration of testicular changes (degeneration of the testicular tubules) was observed in treated male rat, a common effect in ageing rats. However, at the termination of the study, the increased incidence was not of statistical significance'
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
fetal/pup body weight changes
changes in postnatal survival
external malformations
other: No effect observed
Abnormalities:
not specified
Localisation:
other:
Description (incidence and severity):
not specified
Developmental effects observed:
not specified
Treatment related:
not specified
Relation to maternal toxicity:
not specified
Dose response relationship:
not specified
Relevant for humans:
not specified
Conclusions:
NOAEL was considered to be 1000 mg/kg/day for F0 generation and F1 geneartion when Charies river CD®male and female rat were exposed to disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate orally in feed.
Executive summary:

In achronic toxicity and carcinogenicitystudy,Charies river CD®male and femalerat were exposedtodisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate in the concentration 0, 0, 25, 150 and 1000 mg/kg/day orally in feed. In the parental generation,3 rats were died at 150 mg/kg bw, one rat died at 1000 mg/kg bw and 3 rats were died in in control. No effect onbody weight andfood consumption,ophthalmoscopic examination, haematology, clinical chemistry, urinalysis, virology and microbiologyof treated male and female rats was observed as comparable to control.Similarly, No effect onFertilityindex, gestation index and effect on parturition and lactation were observed as compared to control. No effect onorgan weight and gross pathology were observed as compared to control in P and F1 generation. In addition, anacceleration of testicular changes (degeneration of the testicular tubules) was observed in treated male rat, a common effect in ageing rats. However, at the termination of the study, the increased incidence was not of statistical significance. Therefore, NOAEL was considered to be 1000 mg/kg/day for F0 generation and F1 generation when Charies river CD®male and female rat were exposed todisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate orally in feed. 

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
chronic
Species:
rat
Quality of whole database:
Dats is Klimisch 4 and from NTRL and COLIPA
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

Developmental toxicity:

In different studies, disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate has been investigated for developmental toxicity to a greater or lesser extent. Often are the studies based on in vivo experiments and estimated data in rodents, i.e. most commonly in rats and mice for disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate along with the study available on structurally similar read across substance Carmoisine (CAS: 3567-69-9). The predicted data using the OECD QSAR toolbox has also been compared with the experimental studies.

In a experimental study given by Environmental Protection Agency, Washington, DC. Office of Toxic (National Technical Reports Library, NTRL, 1992) and Scientific Committee on Cosmetic Products (COLIPA, SCCNFP, 2004),Charies river CD®male and femalerat were exposed todisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate in the concentration 0, 0, 25, 150 and 1000 mg/kg/day orally in feed. In the parental generation,3 rats were died at 150 mg/kg bw, one rat died at 1000 mg/kg bw and 3 rats were died in in control. No effect onbody weight andfood consumption,ophthalmoscopic examination, haematology, clinical chemistry, urinalysis, virology and microbiologyof treated male and female rats was observed as comparable to control.Similarly, No effect on Fertilityindex, gestation index and effect on parturition and lactation were observed as compared to control. No effect onorgan weight and gross pathology were observed as compared to control in P and F1 generation. In addition, anacceleration of testicular changes (degeneration of the testicular tubules) was observed in treated male rat, a common effect in ageing rats. However, at the termination of the study, the increased incidence was not of statistical significance. Therefore,  NOAEL was considered to be 1000 mg/kg/day for F0 generation and F1 generation whenCharies river CD®male and female rat were exposed todisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate orally in feed.

 Thus, based on the above study on disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate, it can be concluded that NOAEL value is1000 mg/kg/day. Thus, comparing this value with the criteria of CLP regulation, disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate can be Not classified for developmental toxicity.

Justification for classification or non-classification

Based on the above study on disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate, it can be concluded that NOAEL value is1000 mg/kg/day. Thus, comparing this value with the criteria of CLP regulation, disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate can be Not classified for reproduction and developmental toxicity.

Additional information