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EC number: 413-920-6 | CAS number: 88949-33-1
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6.4.2011 - 3.11.2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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 July 27th 1995
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Test material form:
- solid
- Details on test material:
- Red powder
storage at room temperature
unlimited stability
Constituent 1
- Specific details on test material used for the study:
- Red powder
storage at room temperature
unlimited stability
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SPF breeding, VELAZ, Czech Republicc
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: (P) 10 weeks
- Weight at study initiation: mean 319 g (males), 210g (females)
- Fasting period before study: no
- Housing: 2 of the same sex (premating), 1 male and 1 female (mating), single caging (pregnancy), dams with litter
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 27.2.2011 (animal arrival) To: 31.5.2011 (males) and 26.6.2011 (females)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Daily preparation of test substance dosing solution
VEHICLE
- Justification for use and choice of vehicle (if other than water): Water with 0.5% methylcellulose to generate a stable dispersion
- Concentration in vehicle: adjusted to 1ml per 100 g body weight - Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: 14 days
- Proof of pregnancy: Sperm in vaginal smear referred to as day 0 of pregnancy
- Further mating after unsuccessful attempts: no
- After successful mating each pregnant female was caged (how): individual cages
- Any other deviations from standard protocol: no - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- The substance is an insoluble pigment for which a substance-specific analytical method was not available.
- Duration of treatment / exposure:
- 4 weeks (males)
6 weeks (females) - Frequency of treatment:
- Daily
- Details on study schedule:
- males and females - 2 weeks prior to the mating period and during the mating period,
pregnant females - during pregnancy and till the 3rd day of lactation,
males - after mating period - totally for 28 days,
non-pregnant females (mated females without parturition) - for 25 days after the confirmed mating.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 160 mg/kg bw/day (nominal)
- Dose / conc.:
- 400 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: 1000 mg/kg bw is the limit dose in the OECD testing guideline. A 14-day dose-range finding study was performed with 125, 250, 500 and 1000 mg/kg bw with each 5 males and females per dose group.
- Fasting period before blood sampling for clinical biochemistry: not applicable
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: males weekly, females weekly in premating and mating, during pregnancy day 0,7,14,20th day and during lactation on day 0, 1 and 4
FOOD CONSUMPTION:
- same schedule as body weight
OTHER:
Vaginal smears daily in mating period - Oestrous cyclicity (parental animals):
- Not examined
- Sperm parameters (parental animals):
- Sperm samples were taken from one epididymis and sperm morphology was assessed. All deviations - (eg broken tail, abnormal form of tail, double head, amorphous head, no head, abnormal form of neck) - were recorded.
- Litter observations:
- Number and sex of pups, stillbirths, live births and presence of gross anomalies
daily observation of behavioural abnormalitites until postnatal day 4 - Postmortem examinations (parental animals):
- Absolute and relative weights of testes, epididymis, prostate gland and pituitary gland, ovaries, uterus
Histopathology of relevant gross lesions, pituitary gland, coagulation gland, prostate gland, seminal vesicles, epididymis, testes, cervix of uterus, ovaries, uterau, vagina - Postmortem examinations (offspring):
- Gross anomalies
Sex
content of milk in stomach - Statistics:
- ANOVA test (QC.Expert 2.5)
- Reproductive indices:
- Male mating index
Female mating index
Male fertility index
Female fertility index
Gestation index - Offspring viability indices:
- Pup survival index (number of live pups on day 4 post partum x 100/number of pups born alive (incl dead pups with aerial lungs)
Pre-implantation loss (Number of corpus lutea - number of implantations)
Post-implantation loss (Number of implantations - number of live births)
Post-natal loss (Number of live births - number of alive at postnatal day 4)
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- excrements coloured by the test substance (two rats in the low dose group, seven rats in the mid dose and 13 rats of the high dose group)
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- See tables 1 and 2
- Food consumption and compound intake (if feeding study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- see tables 3 and 4
- Histopathological findings: neoplastic:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: No adverse effect up to the limit dose.
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: No adverse effect up to the limit dose.
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Overall reproductive toxicity
- Reproductive effects observed:
- no
Any other information on results incl. tables
Table 1: Body weight of males mean) in g | ||||
Dose level (mg/kg bw) | 0 | 160 | 400 | 1000 |
week 0 | 319.65 | 320 | (321.13 | 319.73 |
week 1 | 359.99 | 359.88 | 363.69 | 359.73 |
week 2 | 384.48 | 382.49 | 389.4 | 386.93 |
week 3 | 402.86 | 396.01 | 406.89 | 402.37 |
week 4 | 421.09 | 411.02 | 423.68 | 418.33 |
Table 2
Body weight of females (mean) in g | |||||
Dose level (mg/kg bw) | 0 | 160 | 400 | 1000 | |
premaing | week 0 | 248.59 | 240.48 | 243.08 | 243.33 |
week 1 | 228.81 | 229.18 | 221.84 | 223.18 | |
week 2 | 238.42 | 235.21 | 231.66 | 231.85 | |
gestation | day 0 | 248.59 | 240.48 | 243.08 | 243.33 |
day 7 | 265.84 | 261.75 | 268.25 | 265.03 | |
day 14 | 290.81 | 287.74 | 295.42 | 296.04 | |
day 20 | 347.69 | 359.06 | 351.17 | 354.29 | |
lactation | day 0/1 | 281.91 | 279.45 | 284.37 | 282.13 |
day 4 | 309.83 | 298.54 | 303.30 | 305.93 |
Table 3
Microscopical findings in males | ||||
Dose level (mg/kg bw) | 0 | 160 | 400 | 1000 |
number of animals | 12 | 12 | 12 | 12 |
Pituitary gland: small cysts | 0 | 0 | 1 | 0 |
Testes: less than 10% tubules; degeneration and/or atrophy of germinative epithelium | 2 | 7 | 4 | 3 |
Epididymides: interstitium and epithelium - slight lymphocyte infiltration | 12 | 12 | 12 | 12 |
Prostate gland - atrophy of alveolar epithelium | 0 | 0 | 1 | 0 |
Prostate gland - lymphocyte infiltration - sporadic | 3 | 1 | 2 | 2 |
Prostate gland: functional hyperplasia | 0 | 2 | 0 | 0 |
Table 4
Microscopic findings in females | ||||
Dose level (mg/kg bw) | 0 | 160 | 400 | 1000 |
number of animals | 12 | 12 | 12 | 12 |
animals without findings | 6 | 4 | 4 | 3 |
Pituitary gland: cysts | 0 | 0 | 0 | 1 |
Ovaries: follicular and/or luteal cysts | 0 | 2 | 3 | 1 |
Uterus: signs of previous gravidity - foci of siderphages and/or liphages and/or haemorrhage | 5 | 5 | 4 | 4 |
Uterus: hydrometra | 0 | 0 | 3 | 1 |
Uterus: proliferation of endometrial stroma | 0 | 0 | 1 | 0 |
Vagina: cell detritus in lumen | 3 | 3 | 2 | 2 |
Vagina: mononuclear infiltration of mucosa | 0 | 0 | 1 | 0 |
Applicant's summary and conclusion
- Conclusions:
- The test substance is not toxic to reproduction in rats at the screening level (OECD 421, GLP).
- Executive summary:
The test substance was tested for its potential to cause toxicity to reproduction in rats in a GLP-conform screening test according to OECD guideline 421. The study was performed with gavage doses of 140, 400 and 1000 mg/kg bw using carboxymethyl cellulose as vehicle. Rats were treated prior to mating and during mating. After mating, dams were kept during gestation and until postnatal day 4. The growth (body weight and food consumption) and clinical status of parental animals were not adversely influenced by the test substance treatment, so that no toxic effect of the test substance to parental animals was observed. Biometry and structure of reproductive organs of parental males and females and quality of sperms of parental males were not adversely influenced by the test substance treatment. The ability of male and female animals to successfully mate and produce viable offspring was unaffected by the test substance treatment. The development of pups was not changed in treatment groups. Test-substance coloured chymus in stomatch and/or intestine was registered in rats of all dose levels. Feces also showed the colour of the test substance. No adverse effects on systemic toxicity, reproductive toxicity or pub development were observed up to the highest tested dose. Thus, the NOEL was 1000 mg/kg bw.
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