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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 270-736-7 | CAS number: 68477-53-2 A complex combination of organic compounds obtained by the distillation of products from a steam cracking process. It consists of unsaturated hydrocarbons having carbon numbers predominantly in the range of C5 through C12.
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP, non-guideline animal experimental study, published in peer reviewed literature, limitations in design but contributing to a weight of evidence.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Pregnant rats exposed to toluene by whole body inhalation from day 9-21 of pregnancy. Rats were allowed to litter and offspring assessed for range of developmental effects including learning ability and fertility.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Details on test material:
- Toluene was supplied by Merck (No. 8323), Darmstadt, Germany and had a purity of 99%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar (Bor: Wisw/spf, TNO)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann (Borchen, Germany)
- Age at study initiation: not reported
- Weight on arrival: 180 to 270 g
- Housing: after mating, the females were kept individually caged
- Diet: standard pellet feed (Altromin 1324; Altromin, Lage, Germany), ad libitum
- Water: ad libitum
- Acclimation period: 3 weeks
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 1 °C
- Humidity: 50 ± 5%
- Photoperiod: 12hrs dark / 12hrs light
IN-LIFE DATES: not reported
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: 1m^3 inhalation chamber and an aerosol-generating system (compressor, pump with calibrated syringe, nozzle). The inhalation conditions were controlled by a Multi-Function Unit (TSE), registering temperature (°C), humidity (%), pressure (mBar), oxygen (%) and flow rate (m^3/h) throughout the exposure period. Controls were placed in the same chamber and inhaled fresh air only.
Samples of the gas mixture in the chamber were taken twice daily and the concentrations were determined by headspace gas chromatography. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Achieved exposure concentrations were within 10% of target
- Details on mating procedure:
- One male was mated with three female animals from 6:30 to 9:00 a.m.; the following 24 h was designated day 0 of pregnancy if sperm were detected in the vaginal smears. After mating, the females were kept individually caged and were allowed to deliver to term.
- Duration of treatment / exposure:
- 6h/day
- Frequency of treatment:
- day 9-21 of pregnancy
- Duration of test:
- Day 0 of pregnancy to delivery and then approximately 90 days after delivery
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 300, 600, 1000, 1200 ppm
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
0, 1131, 2261, 3768, 4522 mg/m3
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
0, 271, 628, 951, 1167 ppm
Basis:
analytical conc.
- No. of animals per sex per dose:
- 38, 23, 23, 29 and 24 for the 0, 300, 600, 1000 and 1200 ppm groups respectively
- Control animals:
- yes, sham-exposed
- Details on study design:
- Measurement of toluene blood concentrations: Blood samples were taken from the tail vein on day 20 of pregnancy immediately at the end of exposure from the 300 and 1200 ppm groups. The concentrations of toluene in blood plasma were measured by headspace gas chromatography.
Examinations
- Maternal examinations:
- CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes (no details recorded)
POST-MORTEM EXAMINATIONS: No data - Fetal examinations:
- As soon as possible after birth the number of viable and dead newborn were counted in each litter, the litter weight was measured and the mean pup weight per litter was calculated.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Toluene exposures of 1000 and 1200 ppm resulted in a reduced body weight of rat dams
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEC
- Effect level:
- 1 200 ppm
- Basis for effect level:
- other: other:
- Dose descriptor:
- NOAEC
- Effect level:
- 4 522 mg/m³ air (nominal)
- Basis for effect level:
- other: other:
- Dose descriptor:
- NOAEC
- Effect level:
- 600 ppm
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEC
- Effect level:
- 2 261 mg/m³ air (nominal)
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEC
- Effect level:
- 600 ppm
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- NOAEC
- Effect level:
- 2 261 mg/m³ air (nominal)
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
Toluene exposures of 1200 ppm resulted in lower body weight of offspring at birth and on day 7 and a higher mortality until weaning. Incisor eruption and vaginal opening were also delayed. At 1000 ppm body weight at birth was low and vaginal opening was delayed.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Pregnancy data: The duration of pregnancy was identical in all groups.
Litter data: No significant effects on litter size. The mean body weight of offspring of dams exposed to 1000 and 1200 ppm toluene was significantly lower at birth. The reduction of the offspring mean body weight remained until postnatal day 7 in the 1200 ppm group. There was a significantly higher mortality prior to weaning in the 1200 ppm group (7% v. 2.6%).
Postnatal development: Incisor eruption and vaginal opening were delayed at 1200 ppm. Vaginal opening was also delayed at 1000 ppm.
Fertility: No treatment-related effects.
Development of reflexes:There were no differences in the development of reflexes, rota rod performance and locomotor activity between the offspring of animals exposed to toluene and the controls.
Locomotor activity:There were no differences in locomotor activity between the offspring of animals exposed to toluene and the controls.
Discrimination learning: No concentration-dependent adverse effects were detected.
Applicant's summary and conclusion
- Conclusions:
- Toluene exposures up to 1200 ppm do not induce adverse effects on the behaviour of rat offspring exposed during late embryonic and foetal development. The NOAEC for offspring behaviour is 1200 ppm (4522 mg/m3). The NOAECs for maternal toxicity and developmental toxicity are 600 ppm (2261 mg/m3).
- Executive summary:
Developmental toxicity and post-natal development were assessed in groups of >20 pregnant female rats exposed to toluene via inhalation 6 h/day during gestation (days 9 -21). Exposure concentrations were 0, 300, 600, 1000 or 1200 ppm. A detailed evaluation of physical development of offspring was conducted and the following tests performed: fore-limb grasp reflex, righting reflex, cliff-drop aversion reflex, maintenance of balance on a rotating rod, locomotor activity, learning ability in a discrimination learning test.
Maternal toluene exposures of 1200 ppm resulted in a reduced body weight gain of rat dams and offspring had lower body weight at birth and day 7 and a higher mortality until weaning. Some developmental landmarks (incisor eruption and vaginal opening) were delayed in this group and are likely to be secondary to the effect on body weight. At 1000 ppm maternal body weight gain was low and offspring had low body weight at birth and delayed vaginal opening. 600 ppm (2261 mg/m3) is the NOAEC for both maternal toxicity and developmental toxicity.
There were no differences in the development of reflexes, rota rod performance and locomotor activity that were attributable to treatment with toluene and no effects were found on learning ability in the operant conditioning task. There were no differences in mating, fertility and pregnancy indexes in the F1-generation. 1200 ppm (4522 mg/m3) is the NOAEC for effects on offspring behaviour.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)
Mimo że ECHA udostępnia wiele materiałów online w Twoim języku, część tej strony jest dostępna tylko w języku angielskim. Więcej o praktykach ECHA związanych z mwielojęzycznością.
Witamy na stronie internetowej ECHA. Strona ta nie jest w pełni obsługiwana przez Internet Explorer 7 (i wcześniejsze wersje). Prosimy o zainstalowanie nowszej wersji Internet Explorer.
Niniejsza strona używa plików cookies, aby zapewnić optymalne korzystanie z naszych stron internetowych.
Dodatkowe informacje: jak używamy plików cookies.