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: 903-919-3 | 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
Additional information
According to ECHA factsheet of 15/09/2009 ECHA considers registration dossiers for substances ≥ 1000 t/y as technically complete even if they do not contain the results of a screening study for reproductive/-developmental toxicity if the following condition is met: The dossier contains either the results of, or a testing proposal for, a prenatal developmental toxicity study and either the results of, or a testing proposal for, a 2-generation reproductive toxicity study. Testing proposals for a prenatal developmental toxicity study and for a 2-generation reproductive toxicity study were created in IUCLID sections 7.8.2 and 7.8.3. Details on the proposal can be found in the attached document. The study proposals on reproductive toxicity are still under evaluation by ECHA.
None of the main components of the reaction mass was found to be toxic for reproduction based on literature data, except for TBA, which produced skeletal anomalies in a 19 -day reproduction toxicity study (see table below). Hence, it is possible that a certain degree of developmental toxicity may also be found for the reaction mass.
Table: Reproduction toxicity data for the main components of the reaction mass from literature
|
Oral |
Inhalation |
Conclusion |
DSBE (1) |
From analogue, SBA: Rat, 8-week, 2-generation study: NOAEL (maternal and developmental toxicity): 1771 mg/kg/day |
From analogue, SBA: Rat, 20-day, prenatal developmental toxicity study: NOAEL: 3500 ppm (maternal toxicity) NOAEL: >7000 ppm (developmental toxicity) |
Overall the weight of evidence indicates that analogue sBA does not produce teratogenic (developmental) toxic effects in the developing embryo/fetus of laboratory animals. In a 2-generation study on rats, no effects of SBA on fertility were noted. |
DIPE (2) |
|
Rat, 20-day, prenatal developmental toxicity study: NOAEL: 430 ppm (maternal and developmental toxicity)
Rat, 13-week, subchronic toxicity study: NOAEL: 480 ppm (reproductive effects) |
DIPE is not a teratogen. No changes in reproductive organ weights and structure or sperm and spermatid number were noted in a subchronic toxicity study. |
SBA (3) |
Rat, 8-week, 2-generation study: NOAEL (maternal and developmental toxicity): 1771 mg/kg/day |
Rat, 20-day, prenatal developmental toxicity study: NOAEL: 3500 ppm (maternal toxicity) NOAEL: >7000 ppm (developmental toxicity) |
SBA is not a developmental toxicant. There was no evidence of teratogenic events nor was there evidence of selective developmental toxicity. In a 2-generation study on rats, no effects on fertility were noted. |
TBA (4) |
Rat, 4-weeks, 1-generation study: NOAEL (maternal toxicity) = 1000 mg/kg-bw/day NOAEL (reproductive/developmental toxicity) = 400 mg/kg-bw/day
Mouse, 22-days, prenatal developmental toxicity study: NOAEL (maternal toxicity) = 1500 mg/kg-bw/day LOAEL (developmental toxicity) =1125 mg/kg-bw/day
Mouse, 18-days, prenatal developmental toxicity study: LOAEL (developmental toxicity) = 1550 mg/kg-bw/day |
Rat, 19-day, prenatal developmental toxicity study: NOAEL (maternal toxicity) = 15.2 mg/L LOAEL (developmental toxicity) = 6.06 mg/L
|
A prenatal developmental toxicity study revealed significant increases in the incidence of skeletal anomalies (primarily delayed skeletal ossification) in treated offspring. In a one-generation study, no effects on reproductive organs, mating success, fertility, or sperm quality were observed; however a slight increase in the length of gestation (significance not specified) was observed at the two highest doses. Furthermore, an increase in estrous cycle length was observed in female mice in a 13-week repeated-dose study.
|
(1) HIGH PRODUCTION VOLUME (HPV) CHEMICAL CHALLENGE PROGRAM TEST PLAN For sec-Butyl Ether CAS NO. 6863-58-7, Prepared by: ExxonMobil Chemical Company, November 28,2006
(2) ExxonMobil Chemical Company Shell Chemical LP For: American Chemistry Council, lsopropanol Panel, Diisopropyl Ether HPV Task Group December 12,2005
(3) OECD SIDS Dossier for Butan-2 -ol, CAS No.78 -92 -2, ExxonMobil Biomedical Sciences Inc.,09.01.2002
(4) Robust Summaries for t-Butanol, CAS Number 75 -65 -O USEPA HPV Challenge Program Submission April 10, 2002
Effects on developmental toxicity
Additional information
See discussion on effects on fertility.
Justification for classification or non-classification
Based on the available data on the consitutents, the reaction mass is not classified as toxic to reproduction. This will be verified with the proposed tests.
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.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.