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EC number: 944-461-4 | 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 Dec 2013 - 26 Sep 2014
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Test substance administered day 6-15 of gestation, no individual animal data was included in the study report, body weight recorded every 4-5 days, no food consumption recorded, dams were not examined macroscopically
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- adopted Jan 2001
- Deviations:
- yes
- Remarks:
- test substance administered day 6-15 of gestation, no individual animal data was included in the study report, body weight recorded every 4-5 days, no food consumption recorded, dams were not examined macroscopically
- Qualifier:
- according to guideline
- Guideline:
- other: The Guidelines for the Testing of Chemicals (State Environmental Protection Administration of China) 2004.5
- Deviations:
- no
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromo-2-methylpropoxy)benzene]
- EC Number:
- 306-832-3
- EC Name:
- 1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromo-2-methylpropoxy)benzene]
- Cas Number:
- 97416-84-7
- Molecular formula:
- C23H24Br8O2
- IUPAC Name:
- 1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromo-2-methylpropoxy)benzene]
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Vital River Laboratory Animal Technology Co. Ltd, China
- Weight at study initiation: 200 - 250 g (males and females)
- Fasting period before study: no
- Housing: pregnant rats were individually housed, no further information available
- Diet: animal feed (HFK BIOSCIENCE Co., Ltd, Beijing, China), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 440 - 70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Dosing solutions were prepared at least once per 7 days and each aliquot was stirred prior to dosing.
VEHICLE
- Amount of vehicle (if gavage): 5 mL/kg bw - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1:1
- Length of cohabitation: until successful mating was confirmed
- Proof of pregnancy: vaginal plug or sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- Day 6 -15 of gestation
- Frequency of treatment:
- daily, 7 days/week
- Duration of test:
- From mating to day 20 of gestation
Doses / concentrationsopen allclose all
- Dose / conc.:
- 250 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 20 P females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: the dose levels were chosen based on the results of an acute toxicity study (not available) in which the LD50 value was > 5000 mg/kg bw. The highest dose level in the main study was the limit dose of 1000 mg/kg bw/day as recommended in the OECD guideline 414.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Animals were observed daily for mortality.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Animals were observed from gestation day 0 - 6 for clinical signs, including abortion. Females showing symptoms of abortion were sacrificed and subjected to necropsy.
BODY WEIGHT: Yes
- Time schedule for examinations: On gestation day 0, 5, 9, 13, 17 and 20.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
POST-MORTEM EXAMINATIONS: No data
- Sacrifice on gestation day 20 - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other: placenta and ovaries were examined (no further information given) - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: one third of the pups per litter
- Skeletal examinations: Yes: one third of the pups per litter
- Head examinations: Yes: the same pups that were subjected to soft tissue examination - Statistics:
- Continuous data, including body weights, body weight gain, pup body weights, gestation length, mean live litter size were analysed by using a One-Way Analysis of Variance (ANOVA). If significance (p<0.05) was detected, group by group comparisons were performed using Dunnet's Test. Count data were analysed utilising Chi-Square test for copulation and fertility indices, pup sex ratios, number of live and dead pups per group on lactation day 0, and pup survival after lactation day 0. All analyses utilised 2-tailed tests for a minimum significance level of 5% comparing the control to the treated groups.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not examined
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not examined - Changes in number of pregnant:
- not examined
- Details on maternal toxic effects:
- There was no significant difference in gravid uterus weight between the control and treatment groups.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- systemic
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: no significant adverse systemic effects were observed up to and including the highest dose level
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not examined - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- not examined
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- not examined
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- developmental
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant effects were observed on offspring parameters up to and including the highest dose level
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
Table 1. Parental female body weight (g)
Dose (mg/kg bw/day) |
Control |
250 |
500 |
1000 |
No. of pregnant animals |
20 |
20 |
20 |
20 |
Day of gestation |
Body weight (g)* |
|||
0 |
250.9 ± 16.4 |
247.5 ± 18.0 |
254.2 ± 23.4 |
247.3 ± 14.8 |
5 |
274.0 ± 14.4 |
273.4 ± 17.5 |
279.8 ± 21.4 |
268.9 ± 13.0 |
9 |
290.7 ± 15.6 |
293.2 ± 19.1 |
299.4 ± 20.1 |
285.4 ± 15.9 |
13 |
315.0 ± 18.8 |
319.0 ± 22.9 |
324.2 ± 23.2 |
312.3 ± 30.2 |
17 |
356.3 ± 26.1 |
355.7 ± 34.4 |
362.5 ± 29.4 |
350.0 ± 39.0 |
20 |
400.8 ± 37.6 |
396.4 ± 26.4 |
412.0 ± 29.9 |
403.0 ± 55.2 |
* Mean ± standard deviation
Table 2. Developmental parameters, F1 offspring
Dose (mg/kg bw/day) |
0 |
250 |
500 |
1000 |
Total number of live offspring |
268 |
248 |
267 |
275 |
Live offspring per litter* |
13.4 ± 4.5 |
13.8 ± 3.9 |
12.4 ± 4.2 |
13.8 ± 3.3 |
Number of dead offspring |
2 |
0 |
1 |
4 |
Number of absorbed embryos |
5 |
6 |
3 |
3 |
Foetal body weight (g)* |
3.648 ± 0.38 |
3.638 ± 0.38 |
3.678 ± 0.46 |
3.666 ± 0.42 |
Foetal body length (cm)* |
3.679 ± 0.20 |
3.648 ± 0.23 |
3.700 ± 0.20 |
3.710 ± 0.24 |
* Mean ± standard deviation
Applicant's summary and conclusion
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.