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Coupling reaction products of diazotized 2-amino-6-[(2-substitued ethyl)sulfonyl]naphthalene-1-substituted acid with 4-({4-chloro-6-[ethyl(3-{[2-(substituted oxy)ethyl]sulfonyl}phenyl)amino]-heteromonocycl-2-yl}amino)-5-hydroxynaphthalene-2,7-disubstituted acid and their sodium and potassium salts
EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 Mar - 15 May 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Version / remarks:
- adopted in 1995
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): FAT 40850/B TE
- Physical state: solid powder
- Colour: red
- Analytical purity: 70.6% all coloured organic constituent, 32.4% main constituent
- Composition of test material, percentage of components: 70.6% all coloured organic constituent, 32.4% main constituent
- Purity test date: 07.09.2010
- Lot/batch No.: BOP 01-10
- Expiration date of the lot/batch: 15.07.2015
- Storage condition of test material: room temperature
- Density: 1.738 g/cm³ at 20°C
- Solubility in Water: 128.1 g/L at 20°C
Test animals
- Species:
- rat
- Strain:
- other: Wistar Crl:WI(Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: (P) 10-11 wks
- Weight at study initiation: (P) Males: 257-304 g; Females: 175-213 g
- Housing: individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (Lot. No. 081110)
- Diet: Altromin 1324 maintenance diet for rats and mice (Lot. No. 1307), ad libitum
- Water: tap water, sulphur acidified to a pH of approximately 2.8 (drinking water, municipal residue control, microbiol. controlled periodically), ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark/hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The amount of test substance for each dose concentration was suspended separately in aqua ad injectionem (sterile water) on each administration day, immediately before the administration. Homogeneity was ensured by using a vortex machine.
VEHICLE
- Justification for use and choice of vehicle: Selection was based on the solubility of the test item.
- Concentration in vehicle: 10, 30, 100 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Lot/batch no.: 0195A191 - Details on mating procedure:
- - M/F ratio per cage: 1/1
- Length of cohabitation: no data
- Proof of pregnancy: sperm in vaginal smear referred to as Day 0 of pregnancy
- Females with unsuccessful mating were allowed to mate with other male of the same group.
- Females showing no evidence of copulation up to 14 day mating period were sacrificed 26 days after the last day of the mating period.
- After successful mating each pregnant female was caged individually. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Each concentration was analysed for nominal concentration. Homogeneity in the vehicle was analysed for the low and high dose concentrations. Samples for nominal concentration verification were taken in Week 1 (first week of pre-mating period), Week 3 (first week of mating), Week 5 (gestation) and Week 7 (gestation/lactation).
Samples for homogeneity were taken from the top, middle and bottom of the low and high dose preparation in Weeks 1 and 5.
All concentration samples were stored frozen (approx. -20 °C) until the analysis was performed. - Duration of treatment / exposure:
- Males: 14 days before mating, 14 days during mating
Females: 14 days before mating, 14 days during mating, 20 days during gestation, 3 days during lactation - Frequency of treatment:
- daily
- Details on study schedule:
- - Age at mating of the mated animals in the study: 12-13 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 300 and 1000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 10
- Control animals:
- other: yes, concurrent vehicle; the control group was shared with BSL Study no. 110998, another OECD 421 study, which was performed in parallel.
- Details on study design:
- - Dose selection rationale: The highest dose level was chosen with the aim of inducing toxic effects, but not death or severe suffering. A descending sequence of dose levels was selected in order to demonstrate any dose-related response and a NOAEL.
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily, once daily during weekend/holidays
BODY WEIGHT: Yes
- Time schedule for examinations: All animals were weighed once before assignment to the experimental groups and on the first day of administration.
Males were weighed weekly during the entire study period.
Females were weighed weekly during the pre-mating period, on Gestation Day 0, 7, 14, 20 and on Post-natal Day 0 (within 24 hours of parturition) and Post-natal Day 4 along with pups.
FOOD CONSUMPTION:
- Food consumption was measured on the corresponding day of the body weight measurements after the beginning of the dose administration and was not measured during the mating period. - Sperm parameters (parental animals):
- Parameters examined in P male parental generations: testis weight, epididymis weight
- Litter observations:
- STANDARDISATION OF LITTERS
- Performed on Day 4 postpartum: no
PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
number and sex of pups, stillbirths, live births, runts, presence of gross anomalies
GROSS EXAMINATION OF DEAD PUPS:
yes, for external abnormalities - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals were sacrificed after the completion of mating period (Day 28)
- Maternal animals: All surviving animals were sacrificed on respective PND 4.
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations. Special attention was paid to the organs of the reproductive system.
HISTOPATHOLOGY / ORGAN WEIGHTS
The following tissues were prepared for microscopic examination and weighed, respectively:
ovaries, uterus with cervix, vagina, testes, epididymides, accessory sex organs (prostate, seminal vesicles with coagulating glands as a whole), macroscopic lesions - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspringwere sacrificed at 4 days of age (PND 4).
The animals were subjected to postmortem examinations for gross external abnormalities. - Statistics:
- One-way analysis of variance (ANOVA) followed by DUNETT’s multiple comparison test (p<0.05 was considered as statistical significant).
- Reproductive indices:
- Copulation Index (%) = (No. of rats copulated /No. of pairs) x 100
Fertility Index (%) = (No. of females pregant/No. of females copulated) x 100
Delivery Index(%) = (No. of dams with live newborns/ No. of pregnant dams) x 100 - Offspring viability indices:
- Viability Index (%) = (No. of live offspring at Day 4/ No. of live offspring at birth) x 100
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- histopathology correlates to discoloration in organs (see details below)
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Details on results (P0)
No treatment related clinical signs were observed. There were very few clinical signs recorded in control and treated animals during the study period but these findings were observed transiently post dose administration and had no relevance to treatment.
None of the animals died during the study period.
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)
No effect on body weight was observed in both sexes throughout the complete study period.
REPRODUCTIVE FUNCTION: SPERM MEASURES (PARENTAL ANIMALS):
No treatment-related effects on testis or epididymidis weight were noted. No other sperm parameters were examined.
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS):
No treatment related effect on precoital interval and duration of gestation was observed.
The copulation index, fertility index and delivery index remained unaffected. No effects on mean No. of corporea lutea, No. of implantation sites, No. of live pups born, % pre- and post-implantation loss were observed.
ORGAN WEIGHTS (PARENTAL ANIMALS):
No statistically significant changes in absolute and relative organ weights were observed.
GROSS PATHOLOGY (PARENTAL ANIMALS):
In males, various macroscopic findings observed were yellow spots on epididymides (C:1/10, LD:1/10, MD:1/10), discoloration of epididymides (HD:5/10 animals), reddish discoloration of kidneys (LD: 4/10, MD: 6/10, HD: 10/10 animals), reddish discoloration of testes (HD: 3/10 animals), small testes and epididymides (HD: 1/10 animals).
In females, discoloration of kidneys (LD: 7/10, MD: 6/10, HD: 10/10 animals), cyst on kidneys (LD: 1/10 animal), ureter dilated (HD: 1/10 animal), dark discoloration of lung (HD: 1/10 animal), hardening of ovary (HD: 1/10 animal).
The discoloration of organs as well as reddish discoloration of the digestive tract noted in almost all treated animals is considered to be attributable to the colour of the test item and as such not a systemic effect due to the test item administration.
HISTOPATHOLOGY (PARENTAL ANIMALS):
There were foamy interstitial macrophages observed in testes of one male of MD group and in 9/10 males of HD group. There were no test item-related histological findings noted in other male and female reproductive organs.
Eosinophilic granules in the tubular epithelium of the renal cortex were seen in all animals of HD group and in a proportion of animals of MD group, but not in animals of LD group although macroscopically red discolored. This finding was considered to be due to test item deposition in renal tubuloepithelial cells. Moreover, in all females of the high dose group, renal corticotubular epithelium was diffusely vacuolated, possibly caused by washout of the test item during the histotechnical procedure.
The lung of one high dose female, being macroscopically dark discolored, showed minimal numbers of eosinophilic alveolar macrophages, considered to represent test item deposition.
All histological findings are due to test item deposition and there were no accompanying findings that would indicate organ damage.
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related effects noted.
- Dose descriptor:
- NOAEL
- Remarks:
- fertility
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related effects noted.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
Details on results (F1)
No treatment related effect was observed on total No. of pups born, No. of males, No. of females, sex ratio, live pups, still birth and runt on PND 0 and total No. of live pups and sex ratio on PND 4. Viability index was unaffected.
BODY WEIGHT (OFFSPRING):
No effect on group mean litter weight, total litter weight, male litter weight and female litter weight on PND 0 and PND 4.
GROSS PATHOLOGY (OFFSPRING):
No substance-related gross external findings were observed in any of the treated groups.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Remarks:
- developmental
- Generation:
- F1
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related effects noted.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Table 1: Clinical Observations (P)
Clinical Findings |
Control |
100 mg/kg |
300 mg/kg |
1000 mg/kg |
Males |
||||
Aggressive behavior |
0/10 |
0/10 |
3/10 |
0/10 |
Nasal discharge |
1/10 |
0/10 |
0/10 |
0/10 |
Piloerection |
0/10 |
0/10 |
0/10 |
1/10 |
Salivation |
0/10 |
0/10 |
1/10 |
0/10 |
Alopecia |
1/10 |
0/10 |
1/10 |
0/10 |
Females |
||||
Aggressive behavior |
1/10 |
0/10 |
0/10 |
0/10 |
Nasal discharge |
0/10 |
2/10 |
0/10 |
0/10 |
Piloerection |
0/10 |
1/10 |
0/10 |
1/10 |
Alopecia |
0/10 |
1/10 |
2/10 |
2/10 |
Table 2: Macroscopic Findings (P)
Findings |
Control |
100 mg/kg |
300 mg/kg |
1000 mg/kg |
Males |
||||
Epididymides: yellow spots |
1/10 |
1/10 |
1/10 |
0/10 |
Epididymides: discoloration (reddish) |
0/10 |
0/10 |
0/10 |
5/10 |
Epididymides: small |
0/10 |
0/10 |
0/10 |
1/10 |
Kidney: discoloration (reddish) |
0/10 |
4/10 |
6/10 |
10/10 |
Testes: discoloration (reddish) |
0/10 |
0/10 |
0/10 |
3/10 |
Testes: small |
0/10 |
0/10 |
0/10 |
1/10 |
Females |
||||
Kidney: discoloration (reddish) |
0/10 |
7/10 |
6/10 |
10/10 |
Ureters: dilated |
0/10 |
0/10 |
0/10 |
1/10 |
Lung: discoloration (dark) |
0/10 |
0/10 |
0/10 |
1/10 |
Ovary: hard |
0/10 |
0/10 |
0/10 |
1/10 |
Table 3: Reproductive Indices (%)
|
Control |
100 mg/kg bw |
300 mg/kg bw |
1000 mg/kg bw |
Copulation Index |
100 |
100 |
100 |
100 |
Fertility Index |
60 |
80 |
70 |
60 |
Delivery Index |
100 |
100 |
100 |
100 |
Viability Index |
100 |
100 |
100 |
100 |
Applicant's summary and conclusion
- Conclusions:
- The test substance had no effect on reproductive performance.
CLP: not classified
DSD: not classified
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