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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 939-424-4 | CAS number: 1469983-44-5
- 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 oral toxicity study (standard acute method): LD50 6176 mg/kg bw (rat)
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:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Groups of 4 albino rats (2 male, 2 female) were administered the test material by gavage at doses of approx. 3, 4.5, 7 and 10 g/kg bw (25% w/v Diacid in corn oil). After treatment the animals were observed for 14 days for clinical signs. Body weights were measured at start and end of the observation period. Necropsy was performed on all animals.
- GLP compliance:
- no
- Remarks:
- study performed prior to GLP
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ARS/Sprague-Dawley, Madison, Wisconsin.
- Age at study initiation: Young rats, no exact age available
- Weight at study initiation: 157-191 g
- Fasting period before study: 16 hours
- Housing: Stock cages
- Diet (e.g. ad libitum): Ad libitum, standard laboratory diet
- Water (e.g. ad libitum): Ad libitum, standard water
- Acclimation period: Five days under observation
ENVIRONMENTAL CONDITIONS
No data available - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25% w/v
- Amount of vehicle (if gavage): varying per dose group (increased volume for higher dose)
- Justification for choice of vehicle: generally used vehicle
- Purity: No data available - Doses:
- - 3,038 mg/kg bw
- 4,556 mg/kg bw
- 6,834 mg/kg bw
- 10,250 mg/kg bw - No. of animals per sex per dose:
- 2
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations continuously, weights: initial and final (14 days)
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight, necropsy of animals that died during the observation period - Statistics:
- The acute oral median lethal dose (LD50) was calculated using interpolation methods described by Weil (1952), Thompson (1947) and Thompson and Weil (1952).
- Preliminary study:
- Not relevant
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 6 176 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 5 548.9 - <= 6 803.1
- Remarks on result:
- other: SD of LD50: +/- 627.1 mg/kg
- Mortality:
- No mortality occurred in the two test groups receiving the lowest doses. 3 out of 4 deaths and 4 out of 4 deaths occurred in the 6834 and 10250 mg/kg bw groups during the 14 day observation period, respectively. Deaths occurred within 3 days in all cases.
- Clinical signs:
- other: Hypoactivity, ruffed fur, labored breathing, muscular weakness and diuresis were noted throughout the test groups. Labored breathing was not noted in the low dose group, while muscular weakness and diuresis were only observed in the two highest dose group
- Gross pathology:
- Necropsy examination of the animals that died revealed gastroenteritis. No gross pathologic alterations were noted among the surviving animals.
- Other findings:
- No data available.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study the acute oral toxicity potential of Diacid 1550 was tested in rats by administration of doses varying from 3 to 10 g/kg bw by gavage. The acute oral LD50 was established to be 6176 mg/kg bw and therefore the substance is not considered acute toxic via the oral route and does not have to be classified in accordance with the criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC.
- Executive summary:
Groups of 4 albino rats (2 male, 2 female) were administered by gavage the test material at doses of approx. 3, 4.5, 7 and 10 g/kg bw (25% w/v Diacid in corn oil). After treatment the animals were observed for 14 days for clinical signs. Body weights were measured at start and end of the observation period. Necropsy was performed on all animals.
No mortality occurred in the two test groups receiving the lowest doses. 3 out of 4 deaths and 4 out of 4 deaths occurred in the 6834 and 10250 mg/kg bw groups during the 14 day observation period, respectively. Deaths occurred within 3 days in all cases. Hypoactivity, ruffed fur, labored breathing, muscular weakness and diuresis were noted throughout the test groups. Labored breathing was not noted in the low dose group, while muscular weakness and diuresis were only observed in the two highest dose groups. The increase in clinical signs was dose-related. Body weights of male and female animals were comparable throughout the groups at the start and end of the study. No statistical analysis was performed. Necropsy examination of the animals that died revealed gastroenteritis. No gross pathologic alterations were noted among the surviving animals.
The acute oral LD50 was established to be 6176 mg/kg bw and therefore the substance is not considered acute toxic via the oral route.
Reference
Clinical signs
Dose (mg/kg bw) | Reaction | Time of onset after dose administration | Duration of reaction |
3038 | Hypoactivity | 1 hour | 1 day |
Ruffed fur | 1 hour | 1 day | |
4556 | Hypoactivity | 1 hour | 2 days |
Ruffed fur | 1 hour | 2 days | |
Labored breathing | 3 hours | 6-22 hours | |
6834 | Hypoactivity | 1 hour | 5 days |
Ruffed fur | 1 hour | 5 days | |
Labored breathing | 2 hours | 2 days | |
Muscular weakness | 3 hours | 2 days | |
Diuresis | 6-22 hours | 2 days | |
10250 | Hypoactivity | 1 hour | Until death |
Ruffed fur | 1 hour | ||
Labored breathing | 2 hours | ||
Muscular weakness | 3 hours | ||
Diuresis | 6-22 hours |
Body weights
Dose (mg/kg bw) | Animal | Body weight (grams) | |
Initial | Final | ||
3038 | 1-M | 173 | 274 |
2-M | 157 | 258 | |
3-F | 163 | 215 | |
4-F | 164 | 220 | |
4556 | 5-M | 163 | 286 |
6-M | 168 | 286 | |
7-F | 171 | 224 | |
8-F | 190 | 226 | |
6834 | 9-M | 164 | - |
10-M | 163 | 277 | |
11-F | 185 | - | |
12-F | 183 | - | |
10250 | 13-M | 160 | - |
14-M | 174 | - | |
15-F | 191 | - | |
16-F | 176 | - |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 6 176 mg/kg bw
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
Groups of 4 albino rats (2 male, 2 female) were administered by gavage the test material at doses of approx. 3, 4.5, 7 and 10 g/kg bw (25% w/v Diacid in corn oil). After treatment the animals were observed for 14 days for clinical signs. Body weights were measured at start and end of the observation period. Necropsy was performed on all animals.
No mortality occurred in the two test groups receiving the lowest doses. 3 out of 4 deaths and 4 out of 4 deaths occurred in the 6834 and 10250 mg/kg bw groups during the 14 day observation period, respectively. Deaths occurred within 3 days in all cases. Hypoactivity, ruffed fur, labored breathing, muscular weakness and diuresis were noted throughout the test groups. Labored breathing was not noted in the low dose group, while muscular weakness and diuresis were only observed in the two highest dose groups. The increase in clinical signs was dose-related. Body weights of male and female animals were comparable throughout the groups at the start and end of the study. No statistical analysis was performed. Necropsy examination of the animals that died revealed gastroenteritis. No gross pathologic alterations were noted among the surviving animals.
The acute oral LD50 was established to be 6176 mg/kg bw and therefore the substance is not considered acute toxic via the oral route.
Justification for selection of acute toxicity – oral endpoint
One study available which was performed similar to the OECD guidelines.
Justification for classification or non-classification
Based on the available information, Diacid 1550 does not have to be classified as acute toxic via the oral route in accordance with the criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC.
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.