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EC number: 229-861-2 | CAS number: 6790-58-5
- 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
Acute toxicity: oral: LD50 > 2000 mg/kg bw (OECD 401 in rats and mice; WoE, rel.2);
Acute toxicity: dermal: LD50 > 2000 mg/kg bw (similar to OECD 402, K, rel. 2);
Acute toxicity: inhalation: waiver.
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:
- weight of evidence
- Study period:
- From October 10 to October 31, 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Study performed according to OECD test guideline No. 401 but not following GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Fü-Albino outbred stock Ibm:RORO (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Biological Research Laboratories (BRL) CH-4414 Füllinsdorf, Switzerland.
- Age at study initiation: no data
- Weight at study initiation: M: 124.5-140 g ; F: 117-126 g
- Fasting period before study: overnight before treatment, animals were given food again 4 hours after application of the test compound.
- Housing: max 3 per cage
- Diet (e.g. ad libitum): KLIBA 25-343, complete rodent maintenance diet ad libitum.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±10
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 30, 60, 120 and 240 minutes after application and then daily
- Weighing: immediately before treatment and on day 7 and 14.
- Necropsy of survivors performed: yes (CO2 asphyxia) - Statistics:
- None
- Preliminary study:
- Not applicable
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: None
- Gross pathology:
- No pathological changes
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Oral LD50Combined > 2000 mg/kg bw
- Executive summary:
In an acute oral toxicity study performed according to OECD test Guideline No 401, groups of Fü-Albino outbred stock Ibm:RORO (SPF) rats (5/sex) were administered a single oral dose of 2000 mg/kg bw by gavage. The animals were observed for mortality, clinical signs, behaviour and appearance and then necropsied for macroscopic observations. 5 control rats per sex received a standard suspension vehicle.
None of the animals died during the study. No clinical signs were noted and weight gain was within normal range. No signs of gross pathological change were found by necropsy.
Oral LD50Combined > 2000 mg/kg bw
Under the test conditions, the test material is not classified according to the annex I of the Regulation EC No. 1272/2008 (CLP).
This study is considered as acceptable within a weight-of-evidence approach to satisfy the requirement for acute oral toxicity endpoint
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Basic data given: comparable to OECD guideline No 401.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- mouse
- Strain:
- CF-1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: adult
- Weight at study initiation: ca. 25g (25.12)
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): Altromin Haltungsdiät Nr. 1324
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no data - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE: CMC/MED/Type 70 (2%)
MAXIMUM DOSE VOLUME APPLIED: 20 cm3/kg (99.5 g/L) - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 10 males
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Statistics:
- Not applicable
- Preliminary study:
- Not applicable
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: None
- Gross pathology:
- No findings
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Mice Oral LD50(males) > 2000 mg/kg bw
- Executive summary:
In an acute oral toxicity study performed similarly to OECD test Guideline No 401, CF-1 mice (10 males) were administered a single oral dose of Ambroxan diluted in CMC, at 2000 mg/kg bw by gavage. The animals were observed for 14 days.
None of the animals died during the study. No clinical signs were noted and weight gain was within normal range. No signs of gross pathological change were found by necropsy.
Mice Oral LD50(males) > 2000 mg/kg bw
Under the test conditions, the test material is not classified according to the annex I of the Regulation EC No. 1272/2008 (CLP).
This study is considered as acceptable within a weight-of-evidence approach to satisfy the requirement for acute oral toxicity endpoint
Referenceopen allclose all
None
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The two studies performed on the registered substance in rats and mice were non-GLP, but followed or were similar to OECD Test guideline No 401.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
No effects were observed in rats following a 2-hours whole-body exposure to 1 % test substance. Although not fully reliable, this study demonstrated the lack of toxicity of the substance following inhalation exposure. In addition, the low vapour pressure of the substance (0.066 Pa at 20°C) combined with the large particle size (97.2% of particles > 100 µm) indicated an absence of volatility and inhalability; therefore low exposure potential by inhalation is anticipated from dust. Thus, at ambient temperature, no respiratory absorption is expected under normal use and handling of the substance. Moreover, in accordance with column 2 of REACH Annex VIII (§8.5), an additional acute toxicity by inhalation does not need to be conducted since the acute toxicity study is already provided for the oral and dermal routes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1979-07-10 to 1979-07-24
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Although conducted under worst-case conditions (abraded skin, occlusive dressing), no mortality was observed during this study. A repeat study is unlikely to show worse effects; therefore this study was considered sufficiently robust to cover this endpoint.
- Principles of method if other than guideline:
- The abraded skin of albino rabbits (3/sex) was occlusively exposed to undiluted test material for 24 hours at dose of 2000 mg/kg bw. The animals were observed for mortality, clinical signs and body weight for 14 days and then necropsied for macroscopic observations.
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.0 - 3.0 kg bw
No other data - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE: abraded skin
- Area of exposure: back
- % coverage: no data
- Type of wrap if used: the treated areas were covered with large gauze patches and an impervious material was wrapped snugly around the trunk of each animal.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data, any excess material was removed
- Time after start of exposure: 24h - Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 animals/sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes - Statistics:
- none
- Preliminary study:
- not applicable
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: There were no unusual behavioural signs noted.
- Gross pathology:
- No effect
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Dermal LD50Combined > 2000 mg/kg bw
- Executive summary:
In a limit acute dermal toxicity study performed similarly to the OECD guideline No. 402, the abraded skin of albino rabbits (3/sex) was occlusively exposed to undiluted test material for 24 hours at dose of 2000 mg/kg bw. The animals were observed for mortality, clinical signs and body weight for 14 days and then necropsied for macroscopic observations.
No mortality occurred during the study. There were no adverse effects.
Dermal LD50Combined > 2000 mg/kg bw
Under the test conditions, the test material is not classified according to the annex I of the Regulation EC No. 1272/2008 (CLP).
This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- In the key study, conducted under worst-case conditions (abraded skin, occlusive dressing), no mortality was observed. An additional dermal study is unlikely to show worse effects, therefore this study was considered sufficiently robust to cover this endpoint.
Additional information
Acute toxicity: oral
A weight-of-evidence approach was used to conclude on the acute oral toxicity potential. The two studies performed on the registered substance in rats (Hoffmann, 1991) and in mice (Henkel, 1981) were non-GLP, but followed or were similar to OECD Test guideline No 401.
The two studies gave an oral LD50 (rats and mice) > 2000 mg/kg bw.
There were no deaths during the studies. No clinical signs were noted and all animals showed expected gains in bodyweight. No abnormalities were noted at necropsy.
Acute toxicity: dermal
A key study was identified (Biosearch, 1979, rel.2). In this limit acute dermal toxicity study, which was performed similarly to the OECD guideline No. 402, the abraded skin of albino rabbits (3/sex) was occlusively exposed to undiluted test material for 24 hours at dose of 2000 mg/kg bw. The animals were observed for mortality, clinical signs and body weight for 14 days and then necropsied for macroscopic observations. No mortality occurred during the study. There were no adverse effects.
Dermal LD50Combined > 2000 mg/kg bw
Acute toxicity: inhalation
No effects were observed in rats
following a 2-hours whole-body exposure to 1 % test substance. Although
not fully reliable, this study demonstrated the lack of toxicity of the
substance following inhalation exposure. In addition, the low vapour
pressure of the substance (0.066 Pa at 20°C) combined with the large
particle size (97.2% of particles > 100 µm) indicated an absence of
volatility and inhalability; therefore low exposure potential by
inhalation is anticipated from dust. Thus, at ambient temperature, no
respiratory absorption is expected under normal use and handling of the
substance.
Moreover, in accordance with column 2 of REACH Annex VIII (§8.5), an
additional acute toxicity by inhalation does not need to be conducted
since the acute toxicity study is already provided for the oral and
dermal routes.
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self classification:
Acute toxicity via Oral route:
Based on the available data, the substance is not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 2000 mg/kg bw.
Acute toxicity via Dermal route:
Based on the available data, the substance is not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 2000 mg/kg bw.
Acute toxicity (Inhalation):
No data was available.
Specific target organ toxicity: single exposure (Oral):
The classification criteria according to the Annex I of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw≥C > 300 mg/kg bw). No classification is required.
Specific target organ toxicity: single exposure (Dermal):
The classification criteria according to the Annex I of the Regulation (EC) No 1272/2008 as specific target organ toxicant (STOT) – single exposure, dermal are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (dermal) for a Category 1 classification (C≤ 1000 mg/kg bw) and at the guidance value (dermal) for a Category 2 classification (2000 mg/kg bw≥C > 1000 mg/kg bw). No classification is required.
Specific target organ toxicity: single exposure (Inhalation):
No data was available.
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.

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