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EC number: 213-979-6 | CAS number: 1070-70-8
- 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
LD50 p.o. (rat ): 1336 mg/kg bw (BASF AG, 1979)
LD50 dermal (rat): > 400 - < 800 mg/kg (BASF AG, 1979)
LC50 (IRT, rat): > 0.06 mg/L (BASF AG, 1963)
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- 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: WIGA
- Weight at study initiation: male: 190-220g; female: 160-190g
- Fasting period before study: 15-20 hours
- Diet: Herlian MRH-Haltung; H. Eggersmann KG
ENVIRONMENTAL CONDITIONS
no data - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
0.5 % aqueous carboxymethylcellulose formulation
DOSE (mg/kg) | 2150 | 1470 | 1000| 681 |
conentration % (w/v) | 21.5 | 14.7 | 10.0 | 6.81 |
MAXIMUM DOSE VOLUME APPLIED:
Dose volume: 10 ml/kg - Doses:
- 681, 1000, 1470, 2150 mg/kg bw
- No. of animals per sex per dose:
- 10 (one exception: only 9 female animals for dose 1470 mg/kg bw)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: at least 14 days
- Frequency of observations: multiple observations after administration up to 5 hours afterwards; then daily (but not on weekends)
- Frequency of weighing: day 2-5, and also on day 7, 13 and 21
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsies were performed on all animes that died or were sacrificed. - Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 544 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 195 mg/kg bw
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 336 mg/kg bw
- Mortality:
- male: female: male/female
Dose: 681 (mg/kg bw) 1/10 (10%) 0/10 (0%) 1/20 (5%)
Dose: 1000 (mg/kg bw) 2/10 (20%) 3/10 (30%) 5/20 (25%)
Dose: 1470 (mg/kg bw) 5/10 (50%) 8/9 (88.9%) 13/19 (68.4%)
Dose: 2150 (mg/kg bw) 7/10 (70%) 9/10 (90%) 16/20 (80%) - Clinical signs:
- other: Clinical signs (day 0 is day of application; no time specification in brackets: true for whole observation period) 2150 mg/kg bw: irregular breathing, apathy, gasping (day 0-3), tremor, spastic movement, ruffled fur, aggressiveness (day 15-20), diarrhea (
- Gross pathology:
- animals that died:
Heart: acute dilatation of the vestiubules; acute congestive hyperanemia; Liver: peripheral lobus pattern; Stomach: severe vascular injection; partly reddened with extensive bleeding; intestine: vascular injection, atonic, hematinized and diarrheic content; in some cases substance-related malacia of the mucosa; in some cases prominent bleeding of areas of the mucosa; hydrothorax
sacrificed animals:
stomach: forestomach wall thickened, forestomach agglutination; in some cases so-called "button"-formation; in some cases diverticulum formation - Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 in rats for butandioldiacrylate was 1336 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 336 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test was performed in principle as described in OECD test guideline 403. It demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of a test substance at 20 °C. Two groups of young adult laboratory rats (3 per sex per group; a total of 12 animals) were exposed sequentially to the vapors generated by bubbling 200 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 8 h. The exposure was subsequently repeated in the same manner. No analytical determination of the atmosphere concentrations was performed. The nominal concentration was calculated as quotient of the amount of test substance weight loss during exposure, and the amount of air used during exposure. Group-wise documentation of clinical signs was performed over a 7 day study period. Body weight of groups was determined before the start of the study and at the end of the observation period.
- GLP compliance:
- no
- Test type:
- other: inhalation hazard test
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- Exposure:
12 rats for 8 hours; vapour temperature 20°C; concentration 0.06 mg/L;
Addtionally, rat were exposed to vapour generated at 100°C for 1h (6 rats), 3h (12 rats), and 8h (6 rats). Since a lot of substance was lost due to condensation in the pipes, no concentration estimate can be provided for these groups. - Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 8 h
- Concentrations:
- 0.06 mg/L;
- No. of animals per sex per dose:
- 12 animals; 6 male and 6 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Statistics:
- no data
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 0.06 mg/L air (nominal)
- Exp. duration:
- 8 h
- Remarks on result:
- other: no animals died when exposed to saturated vapour for 8 hours (20°C)
- Mortality:
- Mortality did not occur (0/12 died).
When exposed to a saturated atmosphere generated at 100°C (the animals were exposed at RT), 4/6 died when exposed for 1h, 8/12 when exposed for 3h, and 5/6 when exposed for 8h. - Clinical signs:
- other: light mucosa irritation (20°C) The higher concentration achieved when generating the atmosphere at 100°C (despite the significant loss within the pipes) led to severe mucusal irritation, encrusted eyes and nose, dyspnoe, and attempts to escape
- Body weight:
- - Weight at study initiation: group 1 average weight of the 6 animals: 170.8 g
group 2 average weight of the 6 animals: 167.5 g
- Weight at the end of the study: group 1 average weight of the 6 animals: 164.6 g
group 2 average weight of the 6 animals: 164.3 g - Gross pathology:
- nothing abnormal detected (20°C)
- Interpretation of results:
- study cannot be used for classification
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 60 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- only 3 animals / sex used in highest dose
- GLP compliance:
- no
- 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:
- rats: SPF-breed; supplyling company: WIGA, Sulzfeld
diet: Herlian MRH-concentrated feed; suppyling company: H. Eggersmann, Rinteln/Weser; ad libitum
water: ad libitum - Type of coverage:
- occlusive
- Vehicle:
- olive oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: ~49 cm2
- Type of wrap if used: inert foil; fixed with adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing: warm water or water/lutrol mixture; drying using tissue paper
- Time after start of exposure: 24 h
TEST MATERIAL
- Concentration: 50% for concentration 400 mg/kg(in olive oil); for all other concentrations the undeluted test substance was applied. - Duration of exposure:
- 24 h
- Doses:
- 400, 800, 1250, 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 male and 5 female (exception was dose group 2000 mg/kg bw: 3 male and 3 female)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Weighing: one time at the beginning
- Necropsy of survivors performed: yes
- Fur was removed by shaving 15-24 hours before the beginning of the test. Only animals with healthy und undamaged skin were used for the test .
- Other examinations performed: clinical signs, necropsy - Statistics:
- no data
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 400 - < 800 mg/kg bw
- Mortality:
- see table below
- Clinical signs:
- other: Resorptive Symptoms of poisoning: unsteady breathing; apathy; staggering; ruffled fur local irritation: 24 h following application significant primary irritations can be detected, which turns into necrosis on day 4.
- Gross pathology:
- animals that died:
heart: acute dilatation (right side); acute congestive hyperemia;
lung: in some cases acute inflation of medium grade
surviving animals:
no abnormality detected - Interpretation of results:
- Category 3 based on GHS criteria
Reference
Mortality
Dose (mg/kg bw) | conc. (%) | # animals | died within 1 h |
died within 24 h |
died within 48 h |
died within 7 d |
died within 14 d |
2000 | 100 | 3 male | 0/3 | 0/3 | 0/3 | 2/3 | 2/3 |
3 female | 0/3 | 3/3 | 3/3 | 3/3 | 3/3 | ||
1250 | 100 | 5 male | 0/5 | 5/5 | 5/5 | 5/5 | 5/5 |
5 female | 0/5 | 5/5 | 5/5 | 5/5 | 5/5 | ||
800 | 100 | 5 male | 0/5 | 5/5 | 5/5 | 5/5 | 5/5 |
5 female | 0/5 | 5/5 | 5/5 | 5/5 | 5/5 | ||
400 | 50 | 5 male | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
5 female | 0/5 | 1/5 | 1/5 | 1/5 | 1/5 | ||
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 400 mg/kg bw
Additional information
Acute Oral Toxicity
In an acute oral toxicity study similar to OECD 401, groups (10/sex) of Sprague-Dawley rats were administered with a single oral dose (gavage) of the test substance emulsified in CMC at concentrations of 681, 1000, 1470 and 2150 mg/kg bw. Animals were then observed for 14 days. One animal died at 681 mg/kg bw, 5 animals at 1000 mg/kg bw, 13 animals at 1470 mg/kg bw and 16 at 2150 mg/kg bw. Clinical signs that were observed at 2150 mg/kg bw, irregular breathing, apathy, gasping (day 0-3), tremor, spastic movement, ruffled fur, aggressiveness (day 15-20), diarrhea (day 0 and 1), exsiccosis, poor general condition. At1470 mg/kg bw, irregular breathing (day 0-7), apathy (day 0-7), tremor (day 1 - 3), spastic movement (day 0 - 7), ruffled fur (day 1 - 6), diarrhea (day 3), exsiccosis (day 0 - 7), poor general condition (day 0 - 7). At 1000 mg/kg bw: irregular breathing (day 0-7, 13), apathy (day 0-7), spastic movement, ruffled fur (day 1 - 6), exsiccosis (day 0 - 7), poor general condition (day 0 - 7). At 681 mg/kg: bw: irregular breathing (day 0-4), apathy (day 0-4), spastic movement (day 0-1), ruffled fur (day 0 - 4), poor general condition (day 0-4). Animals that died during the study showed acute dilatation of the vestiubules, acute congestive hyperanemia, peripheral lobus pattern (liver), severe vascular injection; partly reddened with extensive bleeding (stomach) vascular injection, atonic, hematinized and diarrheic content; in some cases substance-related malacia of the mucosa; in some cases prominent bleeding of areas of the mucosa, hydrothorax. In sacrificed animals the forestomach wall was thickened and forestomach agglutination was observed. In some cases so-called "button"-formation and diverticulum formation was described. An LD50 of 1336 mg/kg bw was determined for both male and female animals (BASF AG, 1979).
In an older study 5 rats per group were treated via gavage with app. 210, 420, 840, and 1690 mg/kg bw (aqueous emulsion with tragacanth) of the test substance. Animals were then observed for 7 days. All animals died at 1760 mg/kg bw and 3 animals died at 880 mg/kg bw. At 440 and 200 mg/kg no animals died. Clinical signs were temporarily staggering, mild apathy, piloerection. Animals that died showed sepsis (6 animals and focal pneumonia (1 animal). Sacrificed animal at 220 mg/kg showed no unusual findings. At 440 mg/kg slight agglutination of the stomach wall to the peritoneum (1 animal) and severe damage in the area of the forestomach were observed. At 880 mg/kg adhesion of the stomach wall with the peritoneum, perisplenitis, necrotisizing gastritis in the region of the forestomach (severe local damage) occured. An LD50 of approx. 740 mg/kg bw was determined for both male and female animals (BASF AG, 1963).
In a study with two rabbits per group, a single oral dose (gavage) of the test substance was administered at concentrations of app. 260, 530 and 2100 mg/kg bw. Animals were then observed for 7 days. All animals died at 2200 mg/kg, one animal died at 550 mg/kg bw and no animal died at 275 mg/kg bw. Clinical signs were atony, apathy, impairment of the hindlimbs and ataxia, lateral position and temporary inappetence. The animals that died, showed acute dilatation (heart), acute congestive hyperemia, sticky liver (clay-yellow colored) and pale kidney. An LD50 of approx. 550 mg/kg bw was determined (BASF AG, 1975).
Acute Inhalative Toxicity
In an inhalation hazard test, twelve rats (6 males and 6 females) were exposed for 8 hours to a saturated atmosphere (20°C) at a mean concentration of 0.06 mg/L. No mortality was observed. Animals showed light mucosa irritation. No pathological changes were observed at necropsy. The LC50 was > 0.06 mg/L (BASF AG,1963). In an additional test, saturated vapour concentration was generated while heating the liquid substance to 100°C. This led to severe local irritation and mortality in 4/6 rats after exposure for 1h. No concentration can be provided for this setting, since a significant, but undeterminable amount of test substance was lost in the pipes of the exposure apparatus. The maximum concentration calculated based on the vapour pressure at 100°C would have been 19mg/L.
Acute Dermal Toxicity
In an acute dermal toxicity study, goups of 10 rats (male and female) were administered doses of 400, 800 and 1250 mg/kg bw and 6 rats (male and female) with 2000 mg/kg bw. The undiluted substance (for 400 mg/kg bw the test substance was 50% in olive oil) was applied for 24 hours to the intact skin of rats under occlusive conditions. After 24 hours the skin was washed with warm water or water/lutrol mixture and dried with tissue paper. At the high dose (2000 mg/kg) 5/6 animals died within 7 days. All animals died within 24 hours at 1250 and 800 mg/kg bw and 1 animal died within 24 hours at 400 mg/kg bw. Resorptive symptoms of poisoning like unsteady breathing, apathy staggering and ruff fur were observed. Irritation was observed at the application site, which turned into necrosis by post-exposure day 4. The dermal LD50 was > 400 < 800 mg/kg bw (BASF AG, 1979).
Justification for classification or non-classification
Based on the results of the acute oral and dermal testing, the test item has to be classified as acute oral cat. 4 (H302) and acute dermal cat. 3 (H311) according to Regulation (EC) No 1272/2008 (CLP). Even though these concentration cannot be obtained by evaporation at room temperature, mortality occured at concentrations < 19mg/L. For conservative reasons, the substance is thus also classified for acute inhalation cat. 4.
The entry for acute oral toxicity in Table 3.1 of Annex VI of Regulation (EC) No 1272/2008 (CLP) confirms the proposed classification.
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