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EC number: 229-604-4 | CAS number: 6628-04-2
- 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: Via oral route: Key study: test method according to OECD 420 and EU Method B.1. In the preliminary study, the animal treated at 300 mg/kg bw presented signs of toxicity and died. In the main study, no toxicity signs were stated at 50 mg/kg. The test substance is classified as Category III according to OECD GHS criteria.
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:
- From May 11 to July 1, 2015.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test method according to OECD Guideline 420, EU Method B.1 bis and GLP study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Experimental Medicine Centre, Medical University in Bialystok.
- Age at study initiation: 9 weeks old (300 mg/kg bw dose) and 10 weeks old (50 mg/kg bw dose).
- Weight at study initiation: 193.0 g (300 mg/kg bw dose) and 198.0 g (50 mg/kg bw dose), plus 4 animals whose average body weight was 187.5 g were assigned to the 50 mg/kg bw dose group.
- Fasting period before study: 19 hours.
- Housing: Plastic cages covered with wire bar lids. (58 x 37 x 21 cm). Preliminary experiment: 1 animal/cage. Main experiment: 4 animals/cage. UV-sterilized wood shavings were used as bedding.
- Diet (e.g. ad libitum): Ad libitum access to the “Murigran” standard granulated laboratory fodder (lot numbers: 3/15 and 4/15) produced by Wytwórnia Koncentaratów i Mieszanek Paszowych AGROPOL, Motycz.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: The animals were quarantined for 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-26 ºC.
- Humidity (%): 40-80%
- Air changes (per hr): about 16 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark. - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1%
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 1 ml of suspension contained 10 mg of the test item.
- Amount of vehicle (if gavage): 0.5 mL/100 g bw
MAXIMUM DOSE VOLUME APPLIED: 1 mililiter.
DOSAGE PREPARATION (if unusual):The test item was carefully mixed with 1% carboxymethylcellulose. The test item (a suspensin oin 1% carboxymethylcellulose) in a volume of 0.5 mL/100 g. The suspension of the test item in 1% carboxymethylcellulose was prepared on the administration day (shortly before the administration).
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No previous data were available. - Doses:
- 50 and 300 mg/kg bw
- No. of animals per sex per dose:
- Preliminary study: 1 female per dose.
Main study: 4 additional females. - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: Daily.
- Necropsy of survivors performed: yes.
- Other examinations performed: clinical signs, body weight, gross necropsy examinations. - Preliminary study:
- Following single administration of the test item at a dose of 300 mg/kg bw, the following signs of toxicity were observed: rounded back, wavering gait, slight and distinc decreases of locomotor activity, and tremors. The animal died during the 2nd hour after the administration of the test item.
Following single administration of the test item at a dose of 50 mg/kg bw, no signs of toxicity were stated. - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 50 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All the animals survived the main experiment.
- Clinical signs:
- other: No signs of toxicity were stated.
- Gross pathology:
- The animals did not exhibit any pathological chagnes.
- Interpretation of results:
- Category 3 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- In the preliminary study, the animal treated at 300 mg/kg bw presented signs of toxicity and died. In the main study, no toxicity signs were stated at 50 mg/kg. The test substance is classified as Category III according to OECD GHS criteria.
- Executive summary:
This study was performed according to OECD Guideline 420 and EU method B.1 (Fixed Dose Method) and following GLP. It intended to assess the toxicity properties of the test item when administered through oral route. It was performed on female Wistar rats. Since no previous data were available, a Preliminary experiment was performed with a dose of 300 mg/kg bw to 1 animal. The test item (a suspension in 1% carboxymethylcellulose) in a volume of 0.5 mL/100 g b.w. was administered with a metal stomach tube. The animal suffered signs of toxicity: rounded back, wavering gait, slight and distinct decreases of locomotor activity and tremors, and died 2h after the treatment. Consequently, the second female rat was treated with 50 mg/kg bw of the test item without manifesting any clinical sign of toxicity. In the main experiment 4 additional females were treated with 50 mg/kg bw. The animals were observed for 14 days and then euthanized for detailed gross examination. At 50 mg/kg no toxicity signs were stated. The animals survived the experiment. Gross examinations did not reveal any pathological changes. On the grounds of the study results, the test item can be classified as Category 3 according to GHS and to Regulation (EC) No. 1272/2008.
Reference
Table 1. Clinical signs - overall list.
Dose (mg/kg b.w.) |
Day after administration |
Number of living animals |
Animal number |
||||
1* |
2 |
3 |
4 |
5 |
|||
50 |
0 1 |
1 0 |
Signs, D - |
- |
- |
- |
- |
30 |
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 |
5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 |
NC NC NC NC NC NC NC NC NC NC NC NC NC NC NC |
NC NC NC NC NC NC NC NC NC NC NC NC NC NC NC |
NC NC NC NC NC NC NC NC NC NC NC NC NC NC NC |
NC NC NC NC NC NC NC NC NC NC NC NC NC NC NC |
NC NC NC NC NC NC NC NC NC NC NC NC NC NC NC |
* the female from the preliminary experiment
NC=No Changes
Signs= Clinical signs
D=Death
Table 2. Body weights of the animals (g)
Dose |
Animal number |
Day of the experiment / Body weight (g) |
Body weight gain (g) |
||
0 |
7 |
14 |
|||
300 |
1* |
193 |
- |
- |
- |
50 |
1* |
198 |
211 |
228 |
30 |
*the female from the preliminary experiment
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 50 mg/kg bw
- Quality of whole database:
- Klimisch score = 1. GLP study.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute toxicity: via oral route: Key study: The acute oral toxicity study on rats was performed according to OECD Guideline 420 and EU Method B.1 bus (Fixed Dose Method) (GLP study). The Fixed Dose method was applied to female Wistar rats. The preliminary experiment tested a 300 mg/kg bw dose to 1 animal, which suffered evident signs of toxicity and died. Then another animal received 50 mg/kg bw without showing any sign of toxicity. In the main experiment 4 additional females received the same dose without clinical signs in the 14 days observation period. Gross examinations did not reveal any pathological changes. On the grounds of the study results, the test item can be classified as Category 3 according to GHS and to Regulation (EC) No. 1272/2008.
Justification for selection of acute toxicity – oral endpoint
One study available.
Justification for classification or non-classification
On the grounds of the study results, the test item can be classified as Category 3 according to GHS and to Regulation (EC) No. 1272/2008.
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