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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 295-405-4 | CAS number: 92045-23-3 A complex combination of hydrocarbons produced by the distillation of the products of a steam cracking process. It consists predominantly of hydrocarbons having a carbon number of C4, predominantly 1-butene and 2-butene, containing also butane and isobutene and boiling in the range of approximately minus 12°C to 5°C (10.4°F to 41°F).
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- Principles of method if other than guideline:
- Guideline study
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Hydrocarbons, C4, ethylene-manuf.-by-product
- EC Number:
- 270-691-3
- EC Name:
- Hydrocarbons, C4, ethylene-manuf.-by-product
- Cas Number:
- 68476-52-8
- IUPAC Name:
- Hydrocarbons, C4, ethylene-manuf.-by-product
- Reference substance name:
- C4 Crude Butadiene (low 1,3-Butadiene Content)
- IUPAC Name:
- C4 Crude Butadiene (low 1,3-Butadiene Content)
- Reference substance name:
- 25167-67-3, 64742-83-2, 68187-60-0, 68476-44-8, 68955- 28-2, 68956-54-7
- IUPAC Name:
- 25167-67-3, 64742-83-2, 68187-60-0, 68476-44-8, 68955- 28-2, 68956-54-7
- Details on test material:
- - Name of test material (as cited in study report): C4 Crude Butadiene (low 1,3-Butadiene Content)
- Supplier: Texas Petrochemicals, LP
- Substance type: Chemical stream
- Physical state: vapour
- Composition of test material, percentage of components: approx. composition: 10% 1,3-butadiene, 4% isobutane, 4% n-butane, 29% trans-2-butene, 29% 1-butene, 11% isobutylene, 12% cis-2-butene
- Lot/batch No.: lot # 268193
- Storage condition of test material: Supplied in cylinders and stored at approximately 4°C in an enclosed storage building, and kept at approximately 16°C during use.
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD® (Sprague-Dawley) IGS BR
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Portage, Michigan< USA
- Age at study initiation: Approximately 8 weeks
- Weight at study initiation: Approximately 200-300 g (males) and 155-225 g (females)
- Housing: one per cage in stainless steel cages
- Diet: LabDiet® Certified Rodent Diet #5002 (PMI Nutrition International, St. Louis, Missouri) in meal form ad libitum (except during exposures).
- Water: Municipal water ad libitum (except during exposures)
- Acclimation period: At least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 40-70%
- Air changes: 12-15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 24 October 2000 To: 29 November 2000
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- other: air
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 2 m3 stainless steel and glass Rochester-style exposure chambers (1.3m tall x 1.2m wide x 1.2m deep with a pyramidal top and bottom).
- Method of holding animals in test chamber: in stainless steel cages within the exposure chamber
- Temperature, humidity in air chamber: 21.20 ± 1.67, 21.42 ± 0.46, 20.59 ± 0.47, 22.06 ± 0.49°C for 0, 2, 10 and 20 mg/L exposure groups respectively / 46.01 ± 3.36, 53.41 ± 6.93, 51.25 ± 7.86, 39.94 ± 7.32% for 0, 2, 10 and 20 mg/L exposure groups respectively.
- Air flow rate: approximately 450 L/minute
- Air change rate: 12-15 calculated air changes per hour.
TEST ATMOSPHERE
- Brief description of analytical method used: Gas chromatography
- Samples taken from breathing zone: yes - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The distribution of total hydrocarbons within the five sample locations in each chamber ranged from 91.35 to 104.94% of the mean reference value. The analytical concentrations for each chamber were 0.0, 2.17, 9.81 and 19.1 mg/L for the targeted concentrations of 0, 2, 10, and 20 mg/L, respectively
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1:1
- Length of cohabitation: until pregnancy occurred or 2 weeks
- Proof of pregnancy: vaginal plug / sperm in vaginal lavage referred to as day 0 of pregnancy
- After successful mating each pregnant female was caged individually - Duration of treatment / exposure:
- Two weeks prior to breeding, during breeding (up to two weeks), and continuing through day 19 of gestation. The dams were then allowed to deliver their litters, which were retained until postnatal day 4.
- Frequency of treatment:
- 6 hours/day, 7 days/wk
- Duration of test:
- Two weeks prior to breeding, during breeding (up to two weeks), and continuing through day 19 of gestation. The dams were then allowed to deliver their litters, which were retained until postnatal day 4.
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, sham-exposed
- Details on study design:
- - Dose selection rationale: The high-exposure concentration of 20 mg/L was chosen based upon data from previous studies with a similar material. This concentration was approximately 50% of the lower explosive limit, which exceeded a limit test as defined for 90-day, repeated-dose inhalation toxicity studies in U.S. EPA OPPTS Guideline 870.3465. The lower-exposure concentrations were selected to provide exposure-response data for any toxicity that may be observed among the high-exposure group rats and to establish a no-observable-effect level (NOEL).
Examinations
- Maternal examinations:
- CLINICAL OBSERVATIONS: Yes
- Time schedule: twice daily
- Cage side observations included: skin, fur, mucous membranes, respiration, nervous system function (including tremors and convulsions), animal behaviour, moribundity, mortality, and the availability of feed and water, clinical examinations were conducted on all females pre-exposure and weekly throughout the pre-breeding and breeding periods. Mated (sperm positive or plug positive) females received clinical examinations on gestation day (gd) 0, 7, 14, and 21. Females that delivered litters were subsequently evaluated on lactation day (ld) 0, 1, and 4. Females that failed to mate or failed to deliver litters were examined weekly. This examination included a careful, hand-held evaluation of the skin, fur, mucous membranes, respiration, nervous system function (including tremors and convulsions), swelling, masses, and animal behaviour.
BODY WEIGHT: Yes
- Time schedule for examinations: at least once during the pre-exposure period and on the first day of exposure. Females were weighed weekly during the pre-mating and mating periods. During gestation, females were weighed on days 0, 7, 14, and 20. Females that delivered litters were weighed on days 1 and 4 of lactation. Females that failed to mate or deliver a litter were not weighed during the gestation or lactation phases. Body weight gains were determined for the females on gestation days 0-7, 7-14, 14-20, 0-20, and lactation days 1-4.
FOOD CONSUMPTION: Yes
- Time schedule: For females, weekly during the pre-breeding period, not measured during the mating period, following mating, gestation days 0-7, 7-14, 14-20, and on lactation days 1-4. Feed consumption was not recorded for females that failed to mate or deliver a litter.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
- Time schedule for examinations:
POST-MORTEM EXAMINATIONS: Yes
- females that delivered litters were fasted overnight on day 4 of lactation and necropsied the following day. Satellite females for which there was no evidence of successful breeding were necropsied 17 days after the last day of the mating period.
ORGAN WEIGHTS: Yes (brain, liver, kidney, lungs - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: Yes
- Number of implantations: Yes - Fetal examinations:
- All pups surviving to lactation day 4 were examined for gross external alterations, euthanized by oral administration of sodium pentobarbital solution, and then discarded. Any pups found dead were examined to the fullest extent possible.
- Statistics:
- Adult body weights and feed consumption, maternal body weight gains, and pup body weights were analyzed by ANOVA. Gestation length, average time to mating (precoital interval) and litter size were analyzed using a nonparametric ANOVA. Pregnancy rates and mating, conception, fertility and gestation indices were analyzed by the Fisher exact probability test. Evaluation of the neonatal sex ratio was performed by the binomial distribution test. Post-implantation loss, pup survival indices, and other incidence data among neonates were analyzed using the litter as the experimental unit by a censored Wilcoxon test.
- Indices:
- not given
- Historical control data:
- none
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
there was no maternal toxicity
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEC
- Effect level:
- 20 other: mg/L air (20,000 mg/m3)
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEC
- Effect level:
- 20 other: mg/L air (20,000 mg/m3)
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
no embryotoxicity
Effect levels (fetuses)
- Dose descriptor:
- NOAEC
- Effect level:
- 20 other: mg/L air (20,000 mg/m3)
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
There were no deaths or treatment-related clinical observations noted. No significant differences in parental body weights, body weight gains or feed consumption were observed at any dose level tested throughout the duration of the study. There were no treatment-related effects at any dose level on any of the reproductive parameters evaluated in this study. These included measures of reproductive performance (mating, conception and fertility, time to mating, gestation length, litter size), offspring survival (gestation and postnatal survival indices, percent pre- and post-implantation loss), pup body weight and pup sex ratio. The only statistically identified change in any of these parameters was an increase in post implantation loss occurring only at the low-dose. This was considered a spurious finding, given the lack of a dose response. Of the 12 females mated in each group, the number of viable litters produced was 11, 11, 11, and 12 for the 0, 2, 10 and 20 mg/L exposure level groups, respectively. External morphological alterations observed in the pups were limited to a hernia observed in a single pup from the high dose group. Given the low incidence of this finding, it was considered to be a spontaneous finding unrelated to exposure.
Applicant's summary and conclusion
- Conclusions:
- Repeated inhalation exposure of C4 Crude Butadiene, to male and female rats at levels up to 20 mg/L produced no evidence of adverse effects on developmental toxicity or teratogenicity.
- Executive summary:
Male and female Sprague Dawley rats were exposed to C4 Crude Butadiene by inhalation at levels of 0, 2, 10, or 20 mg/L (6h/day, 7 d/week) for two weeks prior to breeding, during breeding (up to two weeks), and through day 19 of gestation. After birth, pups were maintained until postnatal day 4. There was no treatment-related maternal toxicity or effects on developmental toxicity or teratogenicity. Based on these data, the NOAEC for reproductive toxicity was 20 mg/L (20,000 mg/m3), the highest concentration tested.
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.