Registration Dossier
Registration Dossier
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: 306-832-3 | CAS number: 97416-84-7
- 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:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well-documented publication which meets basic scientific principles. The justification for the Read Across approach has been attached to the Section 13.
- Principles of method if other than guideline:
- No available information on method used.
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No available data
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on exposure:
- F0 generation
♂
Exposition premating period: 10 weeks
Exposition mating period: 2 weeks
♀
Exposition premating period: 10 weeks
Exposition mating period: 2 weeks
Exposition during gestation and lactation: Yes
F1 generation
♂
Exposition premating period: 10 weeks
Exposition mating period: 2 weeks
♀
Exposition premating period: 10 weeks
Exposition mating period: 2 weeks
Exposition during gestation and lactation: Yes - Details on mating procedure:
- The F0 generation was sacrificed after the pups were weaned
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No available data
- Duration of treatment / exposure:
- Premating period: 10 weeks
Mating period: 2 weeks
For female exposition to the test substance during gestation and lactation. - Frequency of treatment:
- Daily
- Details on study schedule:
- No available data
- Remarks:
- Doses / Concentrations:
10 mg/kg bw/day
Basis:
no data - No. of animals per sex per dose:
- No available data
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No available data
- Positive control:
- No available data
- Parental animals: Observations and examinations:
- No available data
- Oestrous cyclicity (parental animals):
- No available data
- Sperm parameters (parental animals):
- No available data
- Litter observations:
- No available data
- Postmortem examinations (parental animals):
- No available data
- Postmortem examinations (offspring):
- No available data
- Statistics:
- No available data
- Reproductive indices:
- No available data
- Offspring viability indices:
- No available data
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 1000 mg/kg bw/day group: T4 lower (F0 ♂ ♀); T3 lower (F0 ♂);
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
- Remarks on result:
- not measured/tested
- Remarks:
- Data no available in the NTP
- Remarks on result:
- not measured/tested
- Remarks:
- Data not available in the NTP.
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 1000 mg/kg bw/day group: T4 lower (F1 ♂ ♀); 100 mg/kg bw/day group: T4 lower (F1 ♂ ♀)
- Mortality / viability:
- not specified
- Body weight and weight changes:
- 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
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- ca. 1 000 mg/kg bw/day
- Based on:
- not specified
- Sex:
- male/female
- Basis for effect level:
- other: decreased level of T3 (M), T4 (M,F)
- Critical effects observed:
- not specified
- Reproductive effects observed:
- not specified
- Conclusions:
- NOAEL = 1000 mg/kg bw/day
- Executive summary:
Method
The effects on reproductive performance and fertility were evaluated in a 2 generation study. The substance was administered daily by oral gavage. Sprague Dawley rats were exposed to 10, 100, or 1000 mg/kg bw/day in the F0 generation during 10 weeks premating and during a 2-week mating period. Females were treated also during gestation and lactation. The same treatment regime as in F0 animals was also applied in F1 animals.
Observations
The F0 generation was sacrificed after the pups were weaned, and decreases in T4 levels were found at the high dose in males and females. In the F1 generation, lower serum T4 concentrations were observed in both sexes at 100 and 1000 mg/kg. T3 serum levels were significantly lower only in F0 males of the 1000 mg/kg group. No changes in serum TSH levels, compared to vehicle control animals, were observed in any of the treated groups.
Results
No treatment-related histopathologic changes were observed. The substance has no toxicologically significant effects in fertility or reproductive performance at doses of up to 1000 mg/kg bw/day.
Reference
The F0 generation was sacrificed after the pups were weaned, and decreases in T4 levels were found at the high dose in males and females. In the F1 generation, lower serum T4 concentrations were observed in both sexes at 100 and 1000 mg/kg. T3 serum levels were significantly lower only in F0 males of the 1000 mg/kg group. No changes in serum TSH levels, compared to vehicle control animals, were observed in any of the treated groups.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In order to evaluate the effects of AP 1300S on reproductive performance and fertility, a study on Similar Substance 02 (CAS 79-94-7), a precursor/metabolite of AP 1300 S, has been considered; further information on the justification for the read across approach are attached at the section 13.
The test considered is a 2 generation study. The substance was administered daily by oral gavage. Sprague Dawley rats were exposed to 10, 100, or 1000 mg/kg bw/day in the F0 generation during 10 weeks premating and during a 2-week mating period. Females were treated also during gestation and lactation. The same treatment regime as in F0 animals was also applied in F1 animals.
Serum T3, T4 and TSH concentration have been determined, and lower serum T4 concentrations were observed in both sexes at 100 and 1000 mg/kg in the F1 generation. In the F0 generation decreases in T4 levels were found at the high dose in males and females and T3 serum levels were significantly lower only in F0 males of the 1000 mg/kg group. Nevertheless No treatment-related histopathologic changes were observed. The substance has no toxicologically significant effects in fertility or reproductive performance at doses of up to 1000 mg/kg bw/day.
Taking into account the great similarity between AP 1300 S and Similar Substance 02, AP 1300 S is expected to have a NOAEL for reproduction of 1000 mg/kg bw/day.
Short description of key information:
NOAEL = 1000 mg/kg bw/day
Justification for selection of Effect on fertility via oral route:
Well-documented study. Cited in a reliable internationally accepted source.
Effects on developmental toxicity
Description of key information
NOAEL > 2500 mg/kg bw/day
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well-documented publication which meets basic scientific principles. The justification for the Read Across approach has been attached to the Section 13.
- Principles of method if other than guideline:
- No available information on method used.
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- No available data
- Route of administration:
- oral: unspecified
- Vehicle:
- olive oil
- Details on exposure:
- No available data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No available data
- Details on mating procedure:
- No available data
- Duration of treatment / exposure:
- For the gestation period (animals sacrified 20 days)
- Frequency of treatment:
- Daily
- Duration of test:
- Animals sacrified during gestation: 20 days for
Animal not sacrified during gestation: Gestation period
Offspring: 21 days post-natal - Remarks:
- Doses / Concentrations:
280 mg/kg bw/day
Basis:
no data - Remarks:
- Doses / Concentrations:
830 mg/kg bw/day
Basis:
no data - Remarks:
- Doses / Concentrations:
2500 mg/kg bw/day
Basis:
no data - No. of animals per sex per dose:
- 22 to 24
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No available data
- Maternal examinations:
- ANIMAL SACRIFIED
Gross pathology
ANIMAL NOT SACRIFIED
N. of live and dead offspring
Sex of offspring
Presence of any abnormalities
After sacrifice: Gross pathology - Ovaries and uterine content:
- N. of corpora lutea, implants, surviving foetus, early fetal deaths, late fetal deaths
- Fetal examinations:
- Body weights of surviving foetus
Sex of fetuses
Presence or absence of external abnormalities in foetus
Skeletal abnormalities
Visceral abnormalities
OFFSPRING
During post natal 21-days: Bodyweight, state of growth and general state.
After sacrifice: Skeletal abnormalities and n. of implants. - Statistics:
- No available data
- Indices:
- No available data
- Historical control data:
- No available data
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No toxicologically significant effects in the treated maternal animals throughout gestation. In the early stages of pregnancy in the treated dams there was a slight increase in body weight gain above that of the control animals; by day eight onwards the increase in body weight gain was similar in all groups. In early pregnancy food consumption was significantly reduced in all of the TBBP-A dosed groups, but from mid pregnancy food consumption was increased in the 2500 mg/kg group.
No other differences were evident during the dosing period. With the exception of kidney stones and the resultant deformation of one kidney in one animal in the 830 mg/kg group (clearly not treatment-related), no abnormalities were observed in the dams on gross pathological examination. - Dose descriptor:
- NOAEL
- Effect level:
- > 2 500 mg/kg bw/day
- Based on:
- no data
- Basis for effect level:
- other: developmental toxicity
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No effect on the length of the gestation period and no toxicologically significant effects on fetal development. In the fetuses examined on gestational day 20, on external observation, examination of the internal organs and skeletal observations, there were no findings of toxicological significance. In the offspring that were delivered normally and reared to day 21, no difference in development was observed between the treated and control groups. - Dose descriptor:
- NOAEL
- Effect level:
- > 2 500 mg/kg bw/day (nominal)
- Based on:
- other: similar substance
- Remarks:
- TBBPA is much more toxic analoug compared to AP 1300
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- NOAEL > 2500 mg/kg bw/day
- Executive summary:
Method
The effects on development were evaluated in Pregnant Wistar rats (Noda et al., 1985[1]). The substance was orally administered in olive oil throughout gestation, from day 0 once a day (280, 830 and 2500 mg/kg bw/day). The doses were established from the results of a preliminary study in which no toxicologically significant effects were observed at the top dose of 2500 mg/kg.
Observations
On gestational day 20, approximately two thirds of the animals were sacrificed and examined.
For the animals that were allowed to deliver their offspring naturally, the gestation period was calculated. Offspring were kept up until weaning on post-natal day 21 and then killed and examined for the presence of any abnormalities. The dams were also killed on day 21 post-partum and then examined.
Results
The substance did not produce adverse effects on development in the rat at dose levels up to 2500 mg/kg. Although this dose did not produce maternal toxicity, it is considered sufficiently high to adequately assess developmental toxicity effects by the oral route.
[1]Noda T, Morita S, Ohgaki S and Shimizu M (1985) Safety evaluation of chemicals for use in household products (VII) teratological studies on tetrabromobisphenol-A in rats. Annual report of the Osaka Institute of Public Health and Environmental Sciences 48, 106-112.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 2 500 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
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
In order to evaluate the effects of AP 1300S on reproductive performance and fertility, a study on Similar Substance 02 (CAS 79-94-7), a precursor/metabolite of AP 1300 S, has been considered; further information on the justification for the read across approach are attached at the section 13.
The substance was orally administered in olive oil throughout gestation, from day 0 once a day (280, 830 and 2500 mg/kg bw/day). On gestational day 20, approximately two thirds of the animals were sacrificed and examined.
For the animals that were allowed to deliver their offspring naturally, the gestation period was calculated. Offspring were kept up until weaning on post-natal day 21 and then killed and examined for the presence of any abnormalities. The dams were also killed on day 21 post-partum and then examined.
The substance did not produce adverse effects on development in the rat at dose levels up to 2500 mg/kg. Although this dose did not produce maternal toxicity, it is considered sufficiently high to adequately assess developmental toxicity effects by the oral route.
Taking into account the great similarity between AP 1300 S and Similar Substance 02, AP 1300 S is expected to have a NOAEL for developmental toxicity greater than 2500 mg/kg bw/day.
Justification for selection of Effect on developmental toxicity: via oral route:
Well-documented study. Cited in a reliable internationally accepted source.
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008) for the porpoise of classification for reproductive toxicity, substances are allocated on one of two categories.
The Table 3.7.1(a) set out the Hazard categories for reproductive toxicants:
Category 1: Known or presumed human reproductive toxicant
Substances are classified in Category 1 for reproductive toxicity when they are known to have produced an adverse effect on sexual function and fertility, or on development in humans or when there is evidence from animal studies, possibly supplemented with other information, to provide a strong presumption that the substance has the capacity to interfere with reproduction in humans.
Category 2: Suspected human reproductive toxicant
Substances are classified in Category 2 for reproductive toxicity when there is some evidence from humans or experimental animals, possibly supplemented with other information, of an adverse effect on sexual function and fertility, or on development, and where the evidence is not sufficiently convincing to place the substance in Category 1.
Considering the whole data set AP 1300 S is expected to be non classified for reproductive toxicity according to the CLP Regulation (EC n. 1272/2008).
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.
