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EC number: 701-407-2 | 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
Description of key information
The test substance was tested accoring to OECD 423. The oral LD50 value in Wistar rats was established to be within the range of 500-2000 mgkg body weight (NOTOX 2000). Acute toxocty in a second route is not necessary because the test substance is corrosive to skin.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species Rat, Wistar strain Crl:(WI) BR (outbred, SPF-Quality). Recognised
by international guidelines as the recommended test system (e.g.OECD, EC).
Source: Charles River Deutschland, Sulzfeld, Germany.
Number of animals 15 Animals. Each dose group consisted of 3 animals.of one sex
(females were nulliparous and non-pregnant).
Age and body weight Young adult animals (approx. 6-8 weeks old) were selected. Body
weight variation did not exceed +I- 20% of the sex mean.
Identification Earmark.
Conditions
A controlled environment was maintained in the room with optimal conditions considered as
being approximately 15 air changes per hour, a temperature of 21*3"C, a relative humidity of
30-70% and 12 hours artificial fluorescent light and 12 hours dark per day.
Temporary deviations from the maximum level for relative humidity (with a maximum of 20%)
and from the maximum level for temperature (with a maximum of 1 "C) did occur. Based on
laboratory historical data these deviations were considered not to have affected the study
integrity.
Accommodation
Group housing of 3 animals per sex per cage in labelled Macrolon cages (type IV) containing
purified sawdust as bedding material (SAWI, Jelu Werk, Rosenberg, Germany). Certificates of
analysis were examined and then retained in the NOTOX archives.
Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
Diet
Free access to standard pelleted laboratory animal diet (from Altromin (code VRF I), Lage,
Germany). Certificates of analysis were examined and then retained in the NOTOX archives.
Water
Free access to tap-water. Certificates of quarterly analysis were examined and then retained in
the NOTOX archives. - Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- Method Oral gavage, using a stainless steel stomach tube.
Fasting Food was withheld overnight (for a maximum of 20 hours) prior to
dosing until approximately 3-4 hours after administration of the test
substance.
Frequency Single dosage, on day 1 - Doses:
- Dose level (volume) 2000 mglkg (1 0 mllkg) body weight.
200 mglkg (10 mllkg) body weight.
500* mglkg (10 mllkg) body weight. - No. of animals per sex per dose:
- 3 animals, highest dose only 3 female animals
- Control animals:
- no
- Details on study design:
- The toxicity of the test substance was assessed by stepwise treatment of groups of 3 animals.
The first group was treated at a dose level of 2000 mglkg body weight. The absence or
presence of mortality of animals dosed at one step determined the next step, based on the test
procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity
were to be taken into account for determination of the time interval between the dose groups.
OBSERVATIONS
MortalityNiability Twice daily. The time of death was recorded as precisely as
possible.
Body weights Days 1 (pre-administration), 8 and 15 and at death (if found dead
after day 1).
Clinical signs
Necropsy
At periodic intervals on the day of dosing (day 1) and once daily
thereafter, until day 15. The symptoms were graded according to
fixed scales and the time of onset, degree and duration were
recorded:
Maximum grade 4: grading slight (1) to very severe (4)
Maximum grade 3: grading slight (1) to severe (3)
Maximum grade 1: presence is scored (1).
The moribund animals and animals surviving to the end of the
observation period were sacrificed by asphyxiation using a
oxygenlcarbon dioxide procedure. All animals assigned to the
study were subjected to necropsy and descriptions of all internal
macroscopic abnormalities recorded. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 500 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The incidence of mortality was as follows, presented in chronological order of treatment:
Dose level Mortality Sex
2000 mgkg 3/3 females
200 mglkg 0/3 females
200 mglkg 0/3 males
500 mg/kg 1/3 females
500 mg/kg 0/3 males
The decedents were found on day 1,2 or 3 post-treatment. - Clinical signs:
- other: Clinical signs observed during the study period were as follows: Dose level Clinical signs 2000 mgkg Lethargy, flat posture, slow breathing, moribund, ptosis, hunched posture, piloerection. 200 mglkg Lethargy, uncoordinated movements, hunched posture.
- Gross pathology:
- Macroscopic post mortem examination in the animals found dead revealed:
2000 mgkg: Abnormalities of the stomach (dark red discoloration of the glandula mucosa)
andlor duodenum and jejunum (dark red discoloration).
500 mglkg: No abnormalities.
Macroscopic examination of the surviving animals at termination did not reveal any
abnormalities. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LDS0value of PACM BADGE ADDUCT in Wistar rats was established to be within the range of 500-2000 mgkg body weight.
- Executive summary:
The oral LDS0value of PACM BADGE ADDUCT in Wistar rats was established to be within the range of 500-2000 mgkg body weight.
Reference
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as corrosive to the skin
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as corrosive to the skin
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the acute oral toxicity study, the test substance has not to be classified according to CLP regulation 1272/2008.
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