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: 237-159-2 | CAS number: 13674-87-8
- 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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study, not conducted according to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Principles of method if other than guideline:
- TDCP was administered daily to 20 mated Sprague Dawley female rats/dose group by oral gavage from days 6-15 of gestation
- GLP compliance:
- no
Test material
- Details on test material:
- - Name of test material (as cited in study report): FR-2 (Fyrol)
- Physical state: clear, viscous liquid
- Dosage calculations were based upon an assumed purity of 100%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River breeding Laboratories Inc, Wilmington, MA.
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: Housed individually in a hanging wire cage with access to food and water
- Diet: ad libitum (Purina Laboratory Chow)
- Water: ad libitum
- Acclimation period: 27 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Photoperiod (hrs dark / hrs light): no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Appropriate amount sof test material were mixed on a weight-per-volume basis in a vehicle of corn oil at concentrations of 12.5, 50 and 200 mg/ml
DIET PREPARATION
- Rate of preparation of diet (frequency): weekly
- Mixing appropriate amounts with (Type of food): corn oil
- Storage temperature of food: approx. 4 degrees centigrade - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Data are not available, however from the study report it was indicated that samples of each test solution (one sample taken at the time of preparation and one sample taken at the end of each dosing week - for a total of three weeks) were frozen and sent to the sponsor for analysis of the concentrations of the test material. Samples of corn oil vehicle were also sent to the sponsor.
- Details on mating procedure:
- Subjects are mated prior to study acceptance.
- Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/2
- Length of cohabitation: until mated
- Proof of pregnancy: sperm in vaginal smear, referred to as day 0 of pregnancy - Duration of treatment / exposure:
- Subjects were treated from days 6 - 15 of gestation.
- Frequency of treatment:
- Daily
- Duration of test:
- 10 days.
- No. of animals per sex per dose:
- 20 Females per dose group and 20 females in control group.
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- Mortalities, clinical signs, body weight, feed consumption and necropsy were carried out on adult females.
- Ovaries and uterine content:
- Numbers of corpora lutea, implantations, resorptions, live foetuses and dead foetuses were noted.
- Fetal examinations:
- One third of the foetuses were examined by serial whole body sectioning using Wilson’s technique. The remaining foetuses were eviscerated, fixed and examined for skeletal abnormalities using alizarin red staining.
- Statistics:
- The mean gains in maternal body weights, mean maternal food consumption values, mean ovarian, uterine and litter data and the mean fetal weights and lengths of each treated group were compared to the control group by Student's T-test when the variances of the two groups were not found to differ statistically (F significant), Cochran's approximation of t(t') was utilised. The reproduction indices of the control and treated groups were analysed by the chi-square method. All statistcial analyses were evaluated at a probability level of 0.05.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
There were three mortalities at the highest dose. These may have been caused by intubation errors, as findings at necropsy were not considered indicative of treatment-related effects. Clinical signs of toxicity were marked in most animals of the high dose and consisted of urine stains (19/20), hunched appearance (20/20), salivation (18/20) and alopecia (7/20). Rough coat (3/20), bloody crust around the nose (3/20), thinness (2/20) and depression (1/20) were noted in number of high dose animals also. Some clinical signs were also noted in the mid dose group and these may have been treatment-related (alopecia (1/20), hunched appearance (3/20), rough hair coat (1/20) and urine stains (5/20)). There was a significant body weight loss in mid and high dose animals from days 6-11 of treatment. These treated animals lost 15.6 g and 28.9 g, respectively, when compared to untreated animals who gained 22.1 g during this period. From days 11-15, mean weight gain of mid and low dose groups was not different from control, while mean weight gains were reduced in the 400 mg/kg/day group (50% of control). The overall mean weight gain from days 0-19 was significantly reduced (p<0.05) at 400 mg/kg/day (56% of controls). The mean weight gain in low and mid dose animals was not different to that of untreated animals. Mean food consumption was significantly reduced to 84.8% at 100 mg/kg/day (days 7-11) and at 400 mg/kg/day to an average of 45% throughout treatment. There were no specific findings at necropsy, which were indicative of a treatment-related effect.
Pregnancy rates were unaffected by treatment. The mean number of corpora lutea and implantation sites and the implantation efficiencies of the treated animals surviving to day 19 of gestation were similar to or exceeded control values.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 25 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
The authors considered that data for mean weight and crown-rump length from two of the 100 mg/kg/day litters should be removed, as they appeared to be of an older gestation age. When this was done, there was a slightly lower mean foetal weight (2.21 g) and crown-rump length (3.18 cm) for the 400 mg/kg/day litters when compared to controls (2.42 g and 3.35 cm) respectively, although these did not reach statistical significance. The finding of increased incidence of dilated lateral ventricles of the brain was slight and within the historical control range. There was considerable evidence of retarded skeletal development in the high dose group; incomplete ossification of intraparietal and supraoccipital, nonossified hyoid and nonossified centres in the sternebrae, nonossified centre of the sacral and caudal portions of the vertebrae, nonossified arches of the sacral vertebrae and incomplete ossification of the pubis, and nonossified centres in the metacarpels and metatarsels. Such findings are consistent with the reduced foetal weight, length and viability at this dose level and indicate developmental retardation which may be related to the maternal toxicity seen at 400 mg/kg/day. The finding of increased incidence of foetuses with angulated ribs at 400 mg/kg/day may have been related to treatment but is of unknown biological significance (no historical control data for this effect was included in the report).
Results indicated embryotoxicity in the high dose group. In this group, the rate of resorptions was statistically significantly increased when compared to controls (14.4 % compared to 6.7 %). The foetal viability index for the high dose group was statistically significantly lower than control. No increase was seen at the low or mid doses.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Basis for effect level:
- other: This is based on the statistically significant increased resorptions and the decreased foetal viability index at 400 mg/kg/day.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study Fyrol FR-2 produced no apparent compound-related effects when administered at a dose level of 25 mg/kg bw. Maternal toxicity, limited to adverse effects on body weight and food consumption, was evident at a dose level of 100 mg/kg bw. At the high test level of 400 mg/kg bw, signs of maternal toxicity included adverse clinical findings and dose-related effects on body weight and food consumption. In addition, there were signs of embryo- and fetotoxicity at the high test level which were not expected due to the maternal toxicity observed.
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.

Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
This website uses cookies to ensure you get the best experience on our websites.
Find out more on how we use cookies.