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EC number: 202-013-9 | CAS number: 90-72-2
- 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
The oral toxicity of the test item is > 2000 mg/kg/bw since 3 out of 10 animals died at this dose level (SafePharm, 1992).
As the test item is considered to be corrosive to skin (Skin Corr. 1C) a dermal LD50 study according to a current guideline has not been performed.
As part of a 14-day repeated dermal study rats were exposed to the test item at 1000 mg/kg/bw 6 hours per day for 4 days.
No animal died but this dosage level was terminated for humane reasons due to the severity of the skin effects.
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:
- 1992-01-07 to 1992-02-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- 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:Charles River (UK) Limited,
- Strain:Sprague-Dawley Cr1:CD (SD)
- Sex. male and female
- Age: approximately five to eight weeks old
- Weight at study initiation: Males:126 - 148 g, females:120 - 142 g
- Housing:group-housed, up to 5 animals of the same sex and dose group/cage
- Diet: Rat and Mouse Expanded Diet No. 1, Special Diet, Services Limited, Witham, Essex, U.K.)K,
ad libitum, with the exception of an overnight fast immediately before dosing and for approximately two hours after dosing,
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22 °C
- Humidity (%): 52 - 63 %
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours daily
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- For the purpose of the study the test material was used as supplied. The specific gravit was determined by Safepharm Laboratories Limited and used to calculate the appropriate dose volumes for the required dose levels.
ADMINISTRATION:
- Doses: 1333, 2000, and 3000 mg/kg bw
- Doses per time period: single dose by gavage
- Volume administered or concentration: 1.38-3.10 ml/kg bw - Doses:
- 1333, 2000, and 3000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Post dose observation period: 14 days
EXAMINATIONS:
- clinical signs and mortality: 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days
- body weight: day 0, 7 and 14 (or at death)
- macroscopy - Statistics:
- STATISTICAL METHOD: - Thompson, 1947
- Preliminary study:
- see table above
Animals treated with 2000 mg/kg were found dead one day after dosing. Common signs of systemic toxicity noted were hunched posture, lethargy and ptosis with additional signs of decreased
respiratory rate.
Based on this information, dose levels of 1333, 2000 and 3000 mg/kg bodyweight were selected for the main study. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 169 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 1 916 - < 2 455
- Mortality:
- - Number of deaths at each dose (time of death): at 1333, 2000 and 3000 mg/kg: 0, 1 male (day 4)/2 females (day 1), 10 (day 1)
- Clinical signs:
- other: - At 1333 mg/kg hunched posture; - at 2000 mg/kg lethargy and/or hunched posture and decreased respiratory rate and labored breathing in the male that died. All animals were recovered by day 3; - at 3000 mg/kg lethargy, comatosis, ptosis, ataxia, and hu
- Gross pathology:
- NECROPSY FINDINGS:
- At 1333 mg/kg large amounts of white foci scattered over nog-glandular epithelium of stomach;
- At 2000 mg/kg (in animals that died) and 3000 mg/kg hemorrhagic and red stained lungs, dark or patchy pallored liver, dark colored kidneys, hemorrhagic gastrous mucosa and non-glandular stomach epithelium, gaseous distension or severe hemorrhage of small and large intestine; surviving animals at 2000 mg/kg displayed foci on stomach epithelium. - Other findings:
- no other findings
- Conclusions:
- The oral LD50 for test item in rats was 2169 mg/kg body weight. Test item is practically non-toxic following a single oral exposure.
- Executive summary:
The study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley strain rat. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals (1987) No. 401 "Acute Oral Toxicity" referenced as Method B1 i n 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 83/467/EEC).
The test system was chosen because the rat has been shown to be a suitable model for this type of study and is recommended in the test method. The results of the study are believed to be of value in predicting the likely toxicity of the test material to man.
Groups of ten Sprague-Dawley rats (five male and five female) were orally administered undiluted test item at dose levels of 1333, 2000 and 3000 mg/kg body weight.
Surviving animals were observed daily post-dose for 14 days.
All animals in the low dose group survived. Three out of ten animals in the mid-dose group died. All animals in the high-dose group died.
All surviving animals appeared normal within three days or less of dosing, gained weight, and the only findings seen at necropsy in the survivors were abnormalities of the non-glandular stomach epithelium.
Since this material is corrosive, the stomach findings were not unusual.
The oral LD50 for test item in rats was 2169 mg/kg body weight.
Reference
LD50:
Combined sexes 2169 (1916-2455) mg/kg bw
Males: 2259 (1920-2656) mg/kg bw
Females: 2083 (1707-2540) mg/kg bw
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 169 mg/kg bw
- Quality of whole database:
- The study is a guideline study with Klimisch score 1 (reliable without restriction).
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as corrosive to the skin
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983-09-22 to 1983-10-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- 14-day repeat dermal test
- GLP compliance:
- yes
- Test type:
- other: 14-day repeat dermal test
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain:Sprague-Dawley
- Sex. male
- Age: adult
- Weight at study initiation: Males: 400 - 450 g
- Housing: single
- Diet: ad libitum, Rat and Mouse Expanded Diet No. 1, Special Diet, Services Limited, Witham, Essex, U.K.)K,
- Water (e.g. ad libitum): tap water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3 °C
- Humidity (%): 50 - 80 %
- Photoperiod (hrs dark / hrs light): 12 hours daily - Type of coverage:
- semiocclusive
- Details on dermal exposure:
- - The hair was shaved from the back and flanks of all animals approximately 24 hr before first treatment.
- Each day for 14 days each animal was subject to the following procedure.
Animal weighed and weight recorded.
Animals condition and behaviour observed.
The appropriate volume of test-article was dispensed onto a predetermined quarter of the shaved area.
Care was taken to avoid application of test-article to skin which had visible damage from a previous treatment.
Control animals received no treatment.
The treated area was covered with a gauze patch, held in place by non-irritant adhesive tape
After 6 hr the rat was released from the restraining cage and the dressings removed.
The treated area was washed gently with tap-water to remove any remaining test-article. - Duration of exposure:
- 6 hours
- Doses:
- 4
- No. of animals per sex per dose:
- 8
- Control animals:
- yes
- Details on study design:
- The rat was observed and any abnormalities of behaviour or condition not noted at the morning examination were recorded.
Assessment of degree of irritation
The degree of irritation present in the treated skin was scored numerically - Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 1 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No animals died but skin effects were so severe that treatment was stopped after 4 days. More prolonged treatment with test item was not possible.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: There were no visible signs of systemic toxicity during the study At a dose of 1.0 ml/kg/day the test-article produced a very severe skin response consisting of extensive eschar formation and ulceration. This response was so severe that treatment was disc
- Gross pathology:
- At post-mortem examination no difference was seen between treated and control animals in the appearance of any of the tissues apart from the treated areas of skin.
- Conclusions:
- The dermal LD50 is > 1 ml/kg in rats.
- Executive summary:
The test material is corrosive and with the exception of local effects at the site of administration the test material doesn't appear to cause systemic effects when applied dermally to the skin of rats.
Reference
No deaths occurred during the study, however at a dose of 1.0 ml/kg/day the test-article produced a very severe skin response consisting of extensive eschar formation and ulceration. This response was so severe that treatment was discontinued after 4 days, both to avoid unnecessary suffering and because there was insufficient unaltered skin to which treatment could be applied.
There were no visible signs of systemic toxicity during the study and, within the limits of a gross examination, no organ damage was seen at autopsy. The rats given the 1.0 ml/kg/day dose of test item lost an average of 60 g during the four-day treatment
compared with a slight (4 g) gain by the controls. The treated rats gained weight when dosing was stopped and although the gain over the 14-day period of the study was less than the control the gain over the last ten days was higher than control.
These changes of weight gain possibly reflect a toxic change but might be due to a reduced food intake resulting from the discomfort caused by the severe irritation. Without more detailed data it is not possible to separate these two possibilities.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
The oral toxicity of the test item is > 2000 mg/kg/bw since 3 out of 10 animals died at this dose level. The test material is corrosive so a guideline dermal LD50 study has not been performed. As part of a 14-day test rats were dermally exposed to the test item at 1000 mg/kg/bw 6 hours per day for 4 days. No animals died and no systemic dermal effects occured, however, this dosage level was terminated for humane reasons due to the severity of the local skin effects.
Justification for classification or non-classification
Based on the results of the acute oral and dermal toxicity studies in rats and according to the criteria of EC Regulation 1272/2008 and subsequent regulations on classification, labelling and packaging of substances and mixtures, the test item has not to be classified.
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