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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 836-681-3 | CAS number: 22421-66-5
- 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
The acute oral lethality of MTDID 32918 was evaluated in female Wistar rats. The study was conducted according to OECD 423 in compliance with OECD GLP. Two groups of rats (3 females/group) received 2000 mg/kg bodyweight MTDID 32918 “neat” as a liquid via oral gavage. Crystallization of MTDID 32918 was observed prior to dosing the second group and the test item was heated up and subsequently cooled down to obtain a liquid suitable for dosing. Animals were observed daily for clinical signs and mortality. Body weights were recorded on Day 1 (pre-dose), Day 8 and Day 15. No mortality occurred. Hunched posture, piloerection, and uncoordinated movements were observed for all animals between Days 1 and 3 only. Ptosis and lethargy were noted in 2/6 animals on Day 1. The mean body weight gain shown by the animals over the study in-life period was considered to be similar to that expected for normal untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination of the animals. The rat oral LD50 is >2000 mg/kg with significant signs of clinical toxicity (i.e., hunched posture and uncoordinated movements).
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:
- 2020
- 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)
- Version / remarks:
- 2001
- Deviations:
- no
- Remarks:
- No deviations ocurred that negatively impacted the integrity of the study or results.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: 3M Company, Lot 30029 II
- Expiration date of the lot/batch: 25 July, 2020
- Purity test date: 03 May, 2019
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature protected from light
- Stability under storage conditions: Stable
- Stability under test conditions: Stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test article was dosed neat.
FORM AS APPLIED IN THE TEST: Neat - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8-12 weeks old
- Weight at study initiation: 148-201 g
- Fasting period before study: None
- Housing: On arrival and following assignment to the study, animals were group housed (up to 3 animals of the same sex and same dosing group together) in polycarbonate cages (Makrolon MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) equipped with water bottles. The room in which the animals were kept was documented in the study records. Animals were separated during designated procedures/activities. Each cage was clearly labeled
- Diet (e.g. ad libitum): Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) was provided ad libitum throughout the study.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: At least 5 days
- Method of randomisation in assigning animals to test and control groups: Animals will be assigned to the study at the discretion of the coordinating biotechnician, with all animals within ± 20% of the sex mean body weights. Animals in poor health or at extremes of body weight range will not be assigned to the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24 C
- Humidity (%): 40-70
- Air changes (per hr): 10 or more
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 29 October, 2019 To: 28 January 2020 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DOSAGE PREPARATION: Neat
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed daily for clinical signs and mortality. Body weights were recorded on Day 1 (pre-dose), Day 8 and Day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology - Statistics:
- No statistical analysis will be performed (The method used is not intended to allow the calculation of a precise LD50 value).
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality ocurred during the study.
- Clinical signs:
- other: Hunched posture, piloerecdtion and uncoordinated movments were observed for all animals between Days 1 and 3 only. Ptosis and lethargy were noted for two out of six animals on Day 1.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The rat oral LD50 is >2000 mg/kg with significant signs of clinical toxicity (i.e., hunched posture and uncoordinated movements).
- Executive summary:
The acute oral lethality of MTDID 32918 was evaluated in female Wistar rats. The study was conducted according to OECD 423 in compliance with OECD GLP. Two groups of rats (3 females/group) received 2000 mg/kg bodyweight MTDID 32918 “neat” as a liquid via oral gavage. Crystallization of MTDID 32918 was observed prior to dosing the second group and the test item was heated up and subsequently cooled down to obtain a liquid suitable for dosing. Animals were observed daily for clinical signs and mortality. Body weights were recorded on Day 1 (pre-dose), Day 8 and Day 15. No mortality occurred. Hunched posture, piloerection, and uncoordinated movements were observed for all animals between Days 1 and 3 only. Ptosis and lethargy were noted in 2/6 animals on Day 1. The mean body weight gain shown by the animals over the study in-life period was considered to be similar to that expected for normal untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination of the animals. The rat oral LD50 is >2000 mg/kg with significant signs of clinical toxicity (i.e., hunched posture and uncoordinated movements).
Reference
Additional information
Justification for classification or non-classification
Based on the results of the acute oral lethality study indicating a rat oral LD50 of > 2000 mg/kg bw, AEBP is classified as GHS Category 5.
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.