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EC number: 931-673-7 | CAS number: 1333469-72-9
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2,6-dihydroxy-4-methyl-1-[3-(methylazaniumyl)propyl]pyridin-1-ium sulfate
- EC Number:
- 931-673-7
- Cas Number:
- 1333469-72-9
- Molecular formula:
- C10 H18 N2 O6 S1
- IUPAC Name:
- 2,6-dihydroxy-4-methyl-1-[3-(methylazaniumyl)propyl]pyridin-1-ium sulfate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent, U.K.
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Rationale for use of males (if applicable): not specified
- Age at study initiation: 5 to 8 weeks old
- Weight at study initiation: males 139- 55g, females 124-149g
- Fasting period before study: no
- Housing: in groups of five by sex in solid-floor polypropylene cages with sawdust bedding
- Diet and water: With the exception of an overnight fast immediately before dosing and for approximately two hours after dosing, free access to mains drinking water and food (Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.) was allowed throughout the study.
- Acclimation period: at least 5 days
- Method of randomisation in assigning animals to test and control groups: only selection at random is specified in the report
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21ºC
- Humidity (%): 37-60%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
-
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: range-finding study (1 male, 1 female) - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- dose range-finding study: 1 male, 1 female
main study: 5 males, 5 females - Control animals:
- no
- Details on study design:
- 1) Range-finding study
A range-finding study was performed to determine a dosing regime as follows:
dose level (mg/kg): 2000
specific gravity: 1.326
dose volume: 1.51
1 male/ 1 female
All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.
The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 5 days.
Individual bodyweights were recorded on the day of dosing to allow calculation of individual treatment volumes. No necropsies were performed.
2) Main study
Based on the results of the range-finding study a further group of animals was treated as follows:
dose level (mg/kg): 2000
specific gravity: 1.326
dose volume: 1.51
5 male/ 5 female
All animals were dosed once only in a similar manner to that used in the range-finding study.
The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.
Individual bodyweights were recorded prior to dosing on Day 0 and on Days 7 and 14.
At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Results and discussion
- Preliminary study:
- Individual clinical observations and mortality data are given in Table 1.
There were no deaths. Lethargy was noted.
The results of the range-finding study indicated that the acute oral median lethal dose of the test material was greater than 2000 mg/kg bodyweight.
Based on this information, a dose level of 2000 mg/kg bodyweight was selected for the main study.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- Individual bodyweights, together with weekly bodyweight gain are given in Table 3. All animals showed expected gain in bodyweight during the study.
- Gross pathology:
- No abnormalities were noted at necropsy.
Any other information on results incl. tables
HYMAP: RANGE-FINDING ACUTE ORAL TOXICITY TEST IN THE RAT
Table 1. INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN THE RANGE-FINDING STUDY
Dose level Mg/kg | Animal number & sex | Effects noted after dosing (hours) | Effects noted during period after dosing (days) | |||||||
1/2 | 1 | 2 | 4 | 1 | 2 | 3 | 4 | 5 | ||
2000 | 1-0 Male | L | L | L | L | L | L | 0 | 0 | 0 |
2-0 Female | 0 | 0 | 0 | L | L | 0 | 0 | 0 | 0 |
0= no signs of systemic toxicity; L= lethargy
Table 2. INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN THE MAIN STUDY
Dose level Mg/kg | Animal number & sex | Effects noted after dosing (hours) | Effects noted during period after dosing (days) | ||||||||||||||||
1/2 | 1 | 2 | 4 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | ||
2000 | 3-0 male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
3-1 male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3-2 male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3-3 male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3-4 male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
4-0 female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
4-1 female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
4-2 female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
4-3 female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
4-4 female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
0= no signs of systemic toxicity;
Table 3. INDIVIDUAL BODYWEIGHTS AND WEEKLY BODYWEIGHT GAIN IN THE MAIN STUDY
Dose level mg/kg | Animal number & sex | Bodyweight (g) at day | Bodyweight gain (g) during week | |||
0 | 7 | 14 | 1 | 2 | ||
2000 | 3-0 male | 150 | 221 | 304 | 71 | 83 |
3-1 male | 148 | 181 | 241 | 33 | 60 | |
3-2 male | 147 | 217 | 290 | 70 | 73 | |
3-3 male | 139 | 204 | 274 | 65 | 70 | |
3-4 male | 155 | 229 | 300 | 74 | 71 | |
4-0 female | 124 | 147 | 181 | 23 | 34 | |
4-1 female | 144 | 170 | 189 | 26 | 19 | |
4-2 female | 129 | 171 | 202 | 42 | 31 | |
4-3 female | 149 | 161 | 211 | 12 | 50 | |
4-4 female | 146 | 173 | 206 | 27 | 33 |
Table 4: INDIVIDUAL NECROPSY FINDINGS IN THE MAIN STUDY
Dose level mg/kg | Animal number & sex |
| |
Time of death | Macroscopic observations | ||
2000 | 3-0 male | Killed day 14 | No abnormalities detected |
3-1 male | Killed day 14 | No abnormalities detected | |
3-2 male | Killed day 14 | No abnormalities detected | |
3-3 male | Killed day 14 | No abnormalities detected | |
3-4 male | Killed day 14 | No abnormalities detected | |
4-0 female | Killed day 14 | No abnormalities detected | |
4-1 female | Killed day 14 | No abnormalities detected | |
4-2 female | Killed day 14 | No abnormalities detected | |
4-3 female | Killed day 14 | No abnormalities detected | |
4-4 female | Killed day 14 | No abnormalities detected |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material, HYMAP, in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight. The substance is not classified for acute oral toxicity according to CLP Regulation.
- Executive summary:
A study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1987) No. 401 "Acute Oral Toxicity" referenced as Method B1 in Commission Directive 84/449/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 91/325/EEC).
Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of undiluted test material at a dose level of 2000 mg/kg. The animals were observed for fourteen days after the day of dosing and were then killed for gross pathological examination.
There were no deaths. No signs of systemic toxicity were noted during the study.
All animals showed expected gain in bodyweight during the study.
No abnormalities were noted at necropsy.
The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg body-weigth. No symbol and risk phrase are required according to EEC labelling regulations.
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