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Diss Factsheets
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EC number: - | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 June 2014 to 16 July 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: There were no deviations (unplanned changes) from the study plan.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- 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
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- liquid
- Details on test material:
- - Appearance/physical state: Clear colourless liquid
- Storage conditions: Room temperature in the dark
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Female Wistar s were suppiied by Harlan Laboratories UK Ltd., Oxon, UK.
On receipt the animals were randomly allocated to cages.
The females were nulliparous and non-pregnant. After an acclimatization period of at least five days the animais were selected at random and given a number unique within the study by indelible inkmarking on the tail and a number written on a cage card.
At the start of the study the animais were eight to tweive weeks of age. The body weight variation did not exceed ±20% of the body weight of the initially dosed animal.
The animals were housed in groups of up to four in suspended solid-floor poiypropyiene cages furnished with woodflakes. With the exception of an overnight fast immediateiy before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food was allowed throughout the study. The diet, drinking water and bedding were routinely analyzed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 19 to 25°C and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- 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 the fasted body weight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each dose level to confirm the survival of the previously dosed animals.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 4 (main study) + 1 (preliminary) for a total of 5
- Control animals:
- no
- Details on study design:
- A total of five animals were therefore treated at a dose level of 2000 mg/kg in the study.
Clinical observations were made 1/2, 1, 2, and 4 hours after dosing and then daily for fourteen days. Morbidity and mortality checks were made twice daily.
Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an extemal examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Statistics:
- No statistic: using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test item was made.
Results and discussion
- Preliminary study:
- Yes, with one female
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no deaths.
- Clinical signs:
- Hunched posture was noted two and four hours after dosing in the initial treated animal. No signs of systemic toxicity were noted in the additional treated animals during the observation period.
- Body weight:
- All animals showed expected gains in body weight over the observation period.
- Gross pathology:
- No abnormalities were noted at necropsy.
Any other information on results incl. tables
Table1 Individual Clinical Observations and Mortality Data
Dose Level mg/kg |
Animal Number and Sex |
Effects Noted After Dosing (Hours) |
Effects Noted During Period After Dosing (Days) |
||||||||||||||||
Yz |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2000 |
1-0 Female |
0 |
0 |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-1 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-2 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-3 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0
--- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
H = hunched posture
0 = No signs of systemic toxicity
Table 2 lndividual Body Weights and Body Weight Changes
Dose Level mg/kg |
Animal Number and Sex |
Body Weight(g) at Day |
Body Weight Gain(g) During Week |
||||
0 |
7 |
14 |
1 |
2 |
|||
2000 |
1-0 Female |
167 |
181 |
191 |
14 |
10 |
|
2-0 Female |
171 |
182 |
200 |
11 |
18 |
||
2-1 Female |
175 |
202 |
218 |
27 |
16 |
||
2-2 Female |
175 |
195 |
210 |
20 |
15 |
||
2-3 Female |
|
173 |
193 |
206 -- |
20 |
13
1 |
Table3 lndividual Necropsy Findings
Dose Level mg/kg |
Animal Numbe rand Sex |
Time of Death |
Macroscopic Observations |
|
|
2000 |
1-0 Female |
Killed Day 14 |
No abnormalities detected |
||
2-0 Female |
Killed Day 14 |
No abnormalities detected |
|||
2-1 Female |
Killed Day 14 |
No abnormalities detected |
|||
2-2 Female |
Killed Day 14 |
No abnormalities detected |
|||
2-3 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 item in the female Wistar strain rat was considered to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).
- Executive summary:
Introduction
The study was performed to OECD Guideline No. 420 and EU Method B.1 bis to assess the acute oral toxicity of the test item in the Wistar strain rat.
Methods
Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of test item at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
Results
Mortality: There were no deaths.
Clinical Observations: Hunched posture was noted during the day of dosing in the initial treated animal. There were no signs of systemic toxicity noted in the additional treated animals.
Body Weight: All animals showed expected gains in body weight.
Necropsy: No abnormalities were noted at necropsy.
Conclusion
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was considered to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System- Unclassified).
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