Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Version / remarks:
- 1995
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Han Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories, B.V., Kreuzelweg 53, 5961 NM Horst / Netherlands
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Age at study initiation: (P) 11 wks; (F1) x wks
- Weight at study initiation: (P) Males: 289-338 g; Females: 182-211 g; (F1) Males: x-x g; Females: x-x g
- Fasting period before study: not specified
- Housing: Individually in Makrolon type-3 cages. During the prepairing period, cages with males were interspersed amongst those holding females to promote the development of regular estrus cycles
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 / 12 fluorescent light
IN-LIFE DATES: From: 09/10/2010 To: 11/11/2010 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- First Test Item Administration: Males and Females: Day 1 of pre-pairing
- Details on mating procedure:
- - M/F ratio per cage:
- Length of cohabitation:
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy
- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility.
- Further matings after two unsuccessful attempts: [no / yes (explain)]
- After successful mating each pregnant female was caged (how):
- Any other deviations from standard protocol: - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- Males were treated over a 14-day pre-pairing period and during the pairing period up to
one day before necropsy (ca. 4 weeks). Females were treated throughout the pre-pairing, pairing, gestation and lactation period up to the day 3 post partum (7 weeks). - Frequency of treatment:
- Once daily: A standard dose volume of 10 mL/kg body weight with a daily adjustment to the actual body weight was used.
- Details on study schedule:
- - F1 parental animals not mated until [...] weeks after selected from the F1 litters.
- Selection of parents from F1 generation when pups were [...] days of age.
- Age at mating of the mated animals in the study: [...] weeks - Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- control group (vehicle, Milli Q-Water)
- No. of animals per sex per dose:
- Number of animals: 40 males: 10 per group; 40 females: 10 per group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The dose levels were selected based on a previous Subacute 28-Day Oral Toxicity (Gavage) Study with Yellow PE 3260/SF in Han Wistar rats, RCC Project Number 632182, using dose levels of 0, 50, 200 and 1000 mg/kg/day, where no adverse effects were detected up to and including the dose level of 1000 mg/kg bw/day.
- Rationale for animal assignment (if not random): Computer-generated random algorithm. In addition body weights (recorded on the day of allocation) were taken into consideration in order to ensure similar mean body weights in all groups. - Parental animals: Observations and examinations:
- VIABILITY/MORTALITY: Yes, twice daily.
CLINICAL OBSERVATIONS: Yes
Daily cage-side clinical observations (once daily, during acclimatization and up to day of necropsy). Additionally females were observed for signs of difficult or prolonged parturition, and behavioral abnormalities in nesting and nursing.
BODY WEIGHT: Yes
- Time schedule for examinations: daily from treatment start to day of necropsy.
FOOD CONSUMPTION AND COMPOUND INTAKE:
Males: Weekly during pre-pairing and after pairing periods.
Females: Pre-pairing period days 1 - 8 and 8 - 14, gestation period days 0 - 7, 7 - 14 and 14 - 21 post coitum and lactation period days 1 - 4 post partum.
- Litter observations:
- The litters were examined for litter size, live births, still births and any gross anomalies. The sex ratio of the pups was recorded. Pups were weighed individually (without identification) on day 1 and 4 post partum.
- Postmortem examinations (parental animals):
- SACRIFICE
Males were sacrificed after they had been treated for at least 28 days.
If birth did not occur on the expected date (day 21 post coitum), the dam was sacrificed on day 25 post coitum.
GROSS NECROPSY
All parent animals and pups were examined macroscopically for any structural changes. For the parent animals, special attention was directed at the organs of the reproductive system. The number of implantation sites and corpora lutea were recorded for all dams with litters. The uteri of non-pregnant females were placed in a solution of ammonium sulfide to visualize possible hemorrhagic areas of implantation sites
HISTOPATHOLOGY / ORGAN WEIGHTS
Slides of all organs and tissues collected at terminal sacrifice from the animals of the control and high-dose groups were examined by the study pathologist. The same applied to all occurring gross lesions.
Special emphasis was made on the stages of spermatogenesis and histopathology of interstitial cell structure.
Histological examination of ovaries was carried out on any females that did not give birth. In addition, microscopic examination of the reproductive organs of all infertile males was made.
At the scheduled sacrifice, the testes and epididymides of all parental males were weighed separately. - Postmortem examinations (offspring):
- SACRIFICE
Dams and pups were sacrificed on day 4 post partum.
GROSS NECROPSY
Dead pups, were examined macroscopically. All parent animals and pups were examined macroscopically for any structural changes - Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- All animals survived until the scheduled necropsy.
No adverse effects were noted in males or females at any dose levels.
Treatment with the test item caused orange discoloration of feces in all animals at the dose levels
of 100, 300 and 1000 mg/kg bw/day. This effect was a result of staining ability of the test item
and considered not to be adverse to the animals. - Mortality:
- no mortality observed
- Description (incidence):
- All animals survived until the scheduled necropsy.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No test item-related effects on body weights or body weight gain of males or females were observed at any dose level.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No test item-related effects on food consumption of males or females were observed at any dose
level. - Organ weight findings including organ / body weight ratios:
- no effects observed
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No test item-related effects on the relevant reproductive data (mating performance, fertility,
corpora lutea count, implantation rate and post-implantation loss, duration of gestation, litter size
at first litter check or postnatal loss) were observed at any dose level. - Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: NOAEL for general toxicity (highest dose level used in the study)
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: NOEL for reproduction/developmental toxicity (the highest dose level used in the study)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No findings were noted in pups at first litter check or during the first 4 days post partum.
Pups sex ratio was not affected by the treatment with the test item at any dose level. - Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effects were observed on pup body weight and body weight gain during the first four days
post partum at any dose level. - Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No findings were noted during macroscopic examination of pups at any dose level.
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: NOEL for reproduction / developmental toxicity
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: NOAEL for general toxicity
- Reproductive effects observed:
- not specified
- Conclusions:
- Based on the discoloration of feces occurring in all animals which received the test item, the
NOAEL (No Observed Adverse Effect Level) for general toxicity was established at 1000 mg/kg
bw/day (the highest dose level used in the study).
The NOEL (No Observed Effect Level) for reproduction/developmental toxicity was established
at 1000 mg/kg bw/day (the highest dose level used in the study). - Executive summary:
This study is a valid investigation of the toxicological effects resulting from repeated oral-gavage administration of the test item Yellow PE 3260/SF to rats. Yellow PE 3260/SF was administered in Milli-Q-Water as vehicle at dosages of 100, 300, and 1000 mg/kg body weight/day, and controls received the vehicle only. Yellow PE 3260/SF was administered to male rats for at least 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 pups reached day 4 post partum.
All animals survived the scheduled study period.
With the exception for discoloration of feces, no other test item-related findings were noted in males or females at any dose level. The orange discoloration of feces was observed in all animals treated with the test item. This finding was a result of staining ability of the test item and was considered not to be adverse.
No indices of a general toxicity were observed during the entire study at any dose level. Food consumption, body weights and body weight gain were not affected by the treatment at any dose level. No macroscopical or histopathological findings, which were related to the treatment, were found in males or females in any group as well no changes of organ weights were observed.
The reproduction and developmental parameters investigated within this study did not give any indication of any test item-related effect.
Reference
Gross pathology findings were considered to be within the range of normal background lesions. Only findings common in rats of this strain and age have been noted during gross pathology. All of them were within the range of historical control and are reflecting the usual individual variability. No significant findings for organ weights.
The only effect seen under the conditions of this test was the discoloration of feces occurring in all animals which received the test item. The NOAEL (No Observed Adverse Effect Level) for general toxicity was established at 1000 mg/kg/bw/day (the highest dose level used in the study).
The NOEL (No Observed Effect Level) for reproduction/developmental toxicity was established at 1000 mg/kg bw/day (the highest dose level used in the study).
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Kimisch 1 rated experimental study
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
A valid OECD 421 reproduction/development toxicity screening study has been conducted with the registered substance. The substance proved to be not reprotoxic up to a dose level of 1000 mg/kg bw/d.
The reproduction parameters investigated did not give any indication of any test item-related effects. Mating performance, fertility and duration of gestation were not affected by the treatment with the test item. Relevant reproduction parameters such as mean number of corpora lutea, mean number of implantations per dam, post-implantation losses and litter size were also not affected by the treatment with the test item.
Additional information with regard to this endpoint is available from a vlaid OECD 407 oral subacute toxicity study, in which the following fertility related endpoints were monitored:
- Organ weights: epididymes, testes, ovaries
- Gross pathology: epididymes, testes, prostate gland incl. coagulating glands, ovaries, uterus, vagina, mammary gland.
Findings were considered to be within the range of normal background lesions. Only findings common in rats of this strain and age have been noted during gross pathology. All of them were within the range of historical control and are reflecting the usual individual variability. No significant findings for organ weights.
Overall, no indication of a reproductive toxic potential exist for the registration substance, neither from a reproductive screening study according to OECD 421 nor from additional data on reproductive organs from a repeated dose toxicity study. The NOAEL of 1000 mg/kg body weight with regard to developmental toxicity was established at the highest dose tested.
Justification for selection of Effect on fertility via oral route:
In order to assess the effects of the test substance on fertility via oral route, a valid OECD 421 study from 2011 in rats is available. Further a subacute 28-day oral gavage study in rats provides some information on effects on reproductive organs.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Kimisch 1 rated experimental study
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
A Klimisch-1-rated OECD 421 reproduction/development toxicity screening study has been conducted in the year 2011 on the registration substance. The substance proved to be not reprotoxic up to a dose level of 1000 mg/kg bw/day. Viabilitiy index was 100% in the control group and at the dose levels 300 and 1000 mg/kg bw/day and 94.5% at the dose level of 100 mg/kg bw/day. This difference in viability index in the 100 mg/kg bw/day was due to five pups which were missing on day 2 post partum. All these pups were from one litter. No further posnatal loss was noted at any dose level. No findings were noted in pups at first litter check or during the first 4 days post partum. Pups sex ratio was not affected by the treatment with the test item at any dose level. No effects were observed on pup body weight and body weight gain during the first four days post partum at any dose level. No findings were noted during macroscopic examination of pups at any dose level.
Justification for selection of Effect on developmental toxicity: via oral route:
In order to assess the effects of the test substance on development toxicity via oral route, a valid OECD 421 study from 2011 in rats is available. No other studies are available.
Justification for classification or non-classification
The registered substance proved to be not toxic on reproduction up to a dose level of 1000 mg/kg bw/d, thus no classification of the test item is required.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.