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EC number: 204-661-8 | CAS number: 123-91-1
- 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
Description of key information
The acute oral and acute inhalation toxicity was investigated in studies performed comparable to the relevant OECD guidelines (401 and 403), resulting in an LD50 of approximately 5150 mg/kg bw, and an LC0 of 155 mg/L for 1 hour (which corresponds to 38.75 mg/L for 4 hours), respectively.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- BASF-Test
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation (mean): 226 g (males); 197 g (females)
ENVIRONMENTAL CONDITIONS
no data
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 %, 16 %, and 2 % (v/v)
MAXIMUM DOSE VOLUME APPLIED: 6 mL/animal
- Doses:
- 200, 1600, 3200, 4000, 5000, and 6400 µL/kg bw (corresponding to approx. 206, 1648, 3296, 4120, 5150, and 6592 mg/kg bw) (recalculation of doses based on relative density of 1.03)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Weighing was performed only at the beginning of the study for dose calculation. Observation of clinical signs was performed several times on the day of administration and once daily afterwards with the exception of weekends and on holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, pathology - Statistics:
- No statistics were performed.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 5 150 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 6592 mg/kg bw: 10/10 animals died within 48 hours
5150 mg/kg bw: 5/10 animals died within 7 days
At the lower doses between 4120 and 206 mg/kg bw no mortality was observed. - Clinical signs:
- other: 6592 mg/kg bw: immediately after administration accelerated respiration, squatting posture and in some animals abdominal position were observed. After 5 min atony and apathy, after 10 min abdominal and lateral position, back posture, eye discharge and nar
- Gross pathology:
- Deceased animals:
- heart: acute dilatation; lungs: venous hyperemia, slightly edematous; stomach: bloody ulcerations; intestines: hematinized black contents, diarrheic; liver: pale; kidneys: pale; blood: coagulopathy.
Sacrificed animals:
- without abnormalities. - Interpretation of results:
- GHS criteria not met
Reference
Mortality:
|
Dead animals / treated animals after |
|||||
Dose (mg/kg bw/d) |
Conc. (%) |
No of animals |
1 h |
24 h |
48 h |
7 d |
6592 |
30 |
5 males |
0/5 |
1/5 |
5/5 |
5/5 |
5 females |
0/5 |
3/5 |
5/5 |
5/5 |
||
5150 |
30 |
5 males |
0/5 |
0/5 |
0/5 |
0/5 |
5 females |
0/5 |
1/5 |
1/5 |
5/5 |
||
4120 |
30 |
5 males |
0/5 |
0/5 |
0/5 |
0/5 |
5 females |
0/5 |
0/5 |
0/5 |
0/5 |
||
3296 |
30 |
5 males |
0/5 |
0/5 |
0/5 |
0/5 |
5 females |
0/5 |
0/5 |
0/5 |
0/5 |
||
1648 |
16 |
5 males |
0/5 |
0/5 |
0/5 |
0/5 |
5 females |
0/5 |
0/5 |
0/5 |
0/5 |
||
206 |
2 |
5 males |
0/5 |
0/5 |
0/5 |
0/5 |
5 females |
0/5 |
0/5 |
0/5 |
0/5 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 150 mg/kg bw
- Quality of whole database:
- Comparable to guideline study.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 May - 10 June 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Principles of method if other than guideline:
- Inhalation Risktest as in Annex 1 of OECD 403; method based on the publication by Smyth HF et. al. (1962). Am. Ind. Hyg. Ass. J. 23: 95-107.
- GLP compliance:
- no
- Test type:
- other: inhalation risk test
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa . Wiga Versuchstieranstalt, Sulzfeld
- Strain: Caw-Ico-Wiga (SPF)
- Age at study initiation: 7 - 10 weeks
- Weight at study initiation: males: 180 - 250 g; females: 180 - 250 g
- Housing: 3 animals/cage
- Diet (ad libitum): Herilan MRH as pellets (EGGERSMANN KG, Rinteln)
- Water (ad libitum): dailyapprox. 250 mL tap water/cage
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 50 + 5 %
- Photoperiod (hrs dark / hrs light): 12 h/12 h - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
The product was filled in a column of about 5 cm above a fritted glass disc in a glass cylinder (diameter 30 mm) placed in a water bath at 20 ± 1 °C. Fresh air was bubbled at a rate of 200 L/h through the substance column generating a highly saturated substance-vapour-mixture which was led through six glass tubes containing 3 male and female test animals. Exhaust air was disposed of. In case of exposure periods above 30 min, the substance column was replaced after 30 min by a newly filled column. This column was then used for the remaining exposure period. In case the substance in the glass column was spent well before the end of the first 30 min, the substance column was refilled as often as needed to ensure a constant substance-vapour-mixture at least within the first 30 min. The amount of test substance used in the system was determined at the end of the exposure period by weighing. - Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 7 h
- Concentrations:
- mean: 155 mg/L (corresponding to 43 000 ppm)
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were determined only at test start.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross-pathological examination - Key result
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- ca. 155 mg/L air (nominal)
- Exp. duration:
- 1 h
- Mortality:
- 1 h exposure: 0/12
3 h exposure: 6/12
7 h exposure: 4/18 - Clinical signs:
- other: Vigorous flight attempts, dyspnoea, red eye discharge, eye lids adhering, crust formation on nose, complete closure of the eye lids, snout wiping, loss of the lid reflex, narcosis, apathy, squatting posture, ruffled fur, staggering, halting, high stepping
- Body weight:
- no data
- Gross pathology:
- Deceased animals:
- Heart: acute dilatation
- Stomach: multiple, hemorrhagic erosions, bloody stomach contents
- Lungs: acute pulmonary emphysema
- Intestines: bloody faeces in some sections, atonic, diarrheic contents
Sacrificed animals:
- without findings - Interpretation of results:
- GHS criteria not met
Reference
Mortality:
Exposure time [h] |
1 |
3 |
7 |
No. of dead / no. of treated animals |
0/12 |
6/12 |
4/18 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 38 750 mg/m³ air
- Quality of whole database:
- Comparable to guideline study.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There are no human
data on acute toxicity of 1,4-dioxane available.
The acute
toxicity of 1,4 -dioxane in animals is low. The available BASF studies
on acute oral and inhalation toxicity were selected as the key studies
as they were performed using methods comparable to the relevant OECD
guidelines.
The oral LD50 was 5150 mg/kg bw in rats in a well conducted study.
In a whole body inhalation study performed with Sprague Dawley rats the LC0 for 1 hour exposure was ca. 155 mg/L air (nominal). Extrapolation of this value to 4 hour exposure can be performed. According to Chapter R.8 of REACH Technical Guidance Document, if time extrapolation is considered valid, then the most appropriate approach is to make use of the modified Haber’s law (Cnx t = k, where ‘C’ is the concentration, ‘n’ is a regression coefficient,‘t’ is the exposure time and ‘k’ is a constant). A default value of n=1 is suggested for extrapolating from shorter to longer exposure durations. Therefore, the recalculated LC0 for 4 hours exposure is 38.75 mg/L.
Clinical signs and gross pathological findings of deceased animals indicate that adverse effects may be a result of mucosal irritation induced by the test item.
Only limited data regarding the dermal route of exposure is available, also showing low toxicity. However, in accordance with column 2 Section 8.5 of REACH Annex VIII-X, no dermal acute toxicity study is required as data for the oral and inhalation route are available.
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. The oral
LD50 was greater than 2000 mg/kg bw. The inhalation LC0 was
re-calculated to be 38.75 mg/L. As a result the substance does not
require classification for acute oral or inhalation toxicity under
Regulation (EC) No 1272/2008, as amended for the twelfth time in
Regulation (EU) 2019/521.
Classification concerning acute dermal toxicity is also not warranted.
The test item is legally classified as STOT SE 3 (H335: "May cause respiratory irritation") according to Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation).
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.
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