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EC number: 217-442-7 | CAS number: 1852-16-0
- 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 acute toxicity of the test substance via the oral route was assessed using a limit method similar to OECD Test Guideline 420 using a fixed dose procedure in rats. The LD50 of the test material was > 1000 mg/kg bw.
The acute toxicity via inhalation of the read-across substance, acrylamide, was assessed in two studies, both using a method similar to OECD Test Guideline 433. The LC0 for the test material in rats by inhalation is greater than 12 mg/m3.
The acute toxicity of the test substance via the dermal route was assessed using a method similar to OECD Test Guideline 402 using a standard acute method. The LD50 of the test material is greater than 2000 mg/kg body weight.
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:
- 29 June 2006 to 13 October 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: The pre-test body weight range was 209 - 230 g
- Age at study initiation: Approximately 8 weeks
- Fasting period before study: 16 - 20 hours prior to dosing
- Housing: Animals were housed 1 per cage in suspended wire mesh cages. Bedding was placed beneath the cages and changed at least three times/week.
- Diet: Freely available
- Water: Freely available at all times
- Acclimation period: At least three days
ENVIRONMENTAL CONDITIONS
- Temperature: Not reported, the room was temperature controlled
- Photoperiod: 12 hour light / dark cycle
IN-LIFE DATES:
- From: 27 June 2006
- 10 July 2006 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: The test material was used as received. The dose was based on the sample weight as calculated from the specific gravity.
MAXIMUM DOSE VOLUME APPLIED: 0.24 cc - Doses:
- 1000 mg/kg
- No. of animals per sex per dose:
- Five males
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Animals were observed 1, 4 and 24 hours post-dose for mortality, toxicity and pharmacological effects. Mortality was recorded once daily thereafter for six days.
- Necropsy of survivors performed: No. All animals were humanely sacrificed using CO2 following the study termination. - Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 2 animals died during the test period; the first within 24 hours of administration, the second on Day 2.
- Clinical signs:
- other: Pre-death observations included lethargy, wetness and red staining of the nose/mouth area, negative righting reflex, convulsions, spasms, tremors, unkempt appearance, few faeces, ataxia and wetness of the anogenital area. Instances of lethargy, wetness an
- Interpretation of results:
- other: Category 4 in accordance with EU criteria
- Conclusions:
- Based on the results of this test, the LD50 of the test material was > 1000 mg/kg bw.
Reference
Table 1: Dose Volume and Body Weight
Animal No. |
Sex |
Dose Volume (cc) |
Body weight (g) |
|
Day 0 |
Day7 |
|||
1 |
Male |
0.24 |
230 |
299 |
2 |
Male |
0.22 |
216 |
N/A |
3 |
Male |
0.22 |
209 |
267 |
4 |
Male |
0.23 |
217 |
N/A |
5 |
Male |
0.23 |
221 |
280 |
Mean |
219 |
282 |
||
S.D. |
7.7 |
16.1 |
||
Number |
5 |
3 |
N/A = Not applicable – Animal died before observation period
Table 2: Systemic Observations
Time Period |
Animal No. / Sex |
||||
1/M |
2/M |
3/M |
4/M |
5/M |
|
1 hour |
B |
B |
B, R, T |
B, R |
B, R |
4 hours |
B |
B, 1 |
B, R, I |
B, R, I |
B, R, T, I |
24 hours |
|
1, 2, K, B, I, P, O, 3, X, E |
1 |
Z (204 G) |
1, R, B, 3, X |
Day 2 |
|
1, 2, R, K, I, P, O, X, E, Z (193 G) |
|
|
1, R, X |
Day 3 |
|
|
|
|
2, R |
Day 4 |
|
|
|
|
|
Day 5 |
|
|
|
|
|
Day 6 |
|
|
|
|
|
Day 7 |
|
|
|
|
|
No entry indicates that the animal appeared normal at that observation period.
B = Lethargy
E = Ataxia
I = Convulsion
K = Negative righting reflex
O = Tremors
P = Spasm
R = Anogenital area wet
T = Anogenital area soiled
X = Few faeces
Z = Dead
1= Nose/mouth area stained red
2 = Nose/mouth area wet
3 = Unkempt appearance
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 000 mg/kg bw
- Quality of whole database:
- A single GLP study was available conducted on the target substance in vivo using a method equivalent to a guideline.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- See the Analogue Approach Report attached in Section 13 of the IUCLID dossier.
- Reason / purpose for cross-reference:
- other: Read across to target substance
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 433 draft (Acute Inhalation Toxicity: Fixed Concentration Procedure) (not officially approved)
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- Pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not specified
- Age at study initiation: not specified
- Weight at study initiation: 265-279 g
- Fasting period before study: not specified
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature
- Humidity (%): not specified
IN-LIFE DATES: 15/05/1975 to 29/05/1975 - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: glass chamber
- Exposure chamber volume: 160 litres
- Method of holding animals in test chamber: restricted chamber volume
- Source and rate of air: 50 litres/minute by positive pressure spray nozzle
- Method of conditioning air: not specified
- System of generating particulates/aerosols: not specified
- Method of particle size determination: Royco particle analyser/light scattering
- Treatment of exhaust air: not specified
- Temperature, humidity, pressure in air chamber: not specified
TEST ATMOSPHERE
- Brief description of analytical method used: nominal
- Samples taken from breathing zone: no
VEHICLE: Substance was tesed as an aqueous solution
TEST ATMOSPHERE
- Particle size distribution: 1.95 microns (mean value) with 99% of particles 6 microns or smaller
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 2.95 - Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 1 h
- Concentrations:
- 12 mg of test substance/litre
- No. of animals per sex per dose:
- 6 males (one dose)
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 15/5, 16/5, 19/5, 21/5, 23/5, 28/5, 29/5
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight - Statistics:
- None
- Preliminary study:
- None
- Sex:
- male
- Dose descriptor:
- LC0
- Effect level:
- 12.1 mg/m³ air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 1 h
- Mortality:
- One animal died as a result of an infection unrelated to chemical exposure.
- Clinical signs:
- other: No visible lesions could be attributed to the test material.
- Body weight:
- No effects could be attributed to the test material.
- Gross pathology:
- Not performed.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results of this test indicate that the 50.7 % solution of acrylamide is practically non-toxic by the inhalation route with a LC0 of 12 mg/m3.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 12 mg/m³ air
- Quality of whole database:
- Two studies were available conducted on the read-across substance in vivo using methods equivalent to a guideline. One was conducted to GLP; the other pre-dates GLP
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:
- 26 June 2006 to 13 October 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: The pre-test body weight range was 2.1 - 2.9 kg
- Housing: 1 per cage in suspended wire cages. Bedding was placed beneath the cages and changed at least three times/week.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: At least three days
ENVIRONMENTAL CONDITIONS
- Temperature: Not reported, the room was temperature controlled
- Photoperiod: 12 hour light / dark cycle
IN-LIFE DATES:
- From: Animals were received 21 June, 05 July, 26 July and 23 August 2006
- To: Not reported; date of last data collection was 04 September 2006 - Type of coverage:
- other: occlusive at the lower dose levels, semi-occlusive at the highest dose
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
Prior to application of the test article, the back and sides of each animal were clipped free of hair and remained intact.
- Area of exposure: Approximately 10 %
- Type of wrap if used: Test material was applied under a 4 ply porous gauze dressing measuring 10 x 15 cm at the lower dose levels. The top dose was applied to the prepared site on top of the gauze dressing. The torso was wrapped with plastic sheeting in an occlusive manner for animals dosed at 500, 1000 and 1500 mg/kg. Animals dosed at 2000 mg/kg were wrapped in a semi-occlusive manner. Plastic sheeting was secured with non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were wiped, not washed
- Time after start of exposure: After 24 hours
TEST MATERIAL
Doses were based on the sample weight as calculated from the specific gravity.
- Amount applied:
1.3 to 1.5 cc at 500 mg/kg bw
2.5 to 2.8 cc at 1000 mg/kg bw
3.3 to 3.6 cc at 1500 mg/kg bw.
4.6 to 6.0 cc at 2000 mg/kg bw
VEHICLE
The test material was used as received - Duration of exposure:
- 24 hours
- Doses:
- 500, 1000, 1500 and 2000 mg/kg
- No. of animals per sex per dose:
- Initially, five healthy males were dosed at 500 mg/kg of body weight.
At the sponsor's request and to further characterise the test material, three additional groups of five males were dosed at 1000, 1500 and 2000 mg/kg. - Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Animals dosed at 500 mg/kg were observed at 1, 4 and 24 hours post-dose and animals dosed at 1000, 1500 and 2000 mg/kg were observed at 1, 4 and 24 hours post-dose for mortality, toxicity and pharmacological effects. Animals were observed once daily thereafter for six days for mortality only. Body weights were recorded pre-test and at termination.
- Necropsy of survivors performed: No.
- Other examinations performed: The test sites were scored for dermal irritation at 24 hours post-dose and on day 7 using the Numerical Draize scoring code. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction. Additional signs were described.
Erythema and eschar formation:
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well-defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet redness) to slight eschar formation (injuries in depth)
Oedema formation:
0: No oedema
1: Very slight oedema (barely perceptible)
2: Slight oedema (edges of area well-defined by definite raising)
3: Moderate oedema (edges raised approximately 1 millimetre)
4: Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) - Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- None, all animals survived
- Clinical signs:
- other: All animals appeared normal at post-dose assessments up to 24 hours.
- Gross pathology:
- Not performed.
- Other findings:
- - At 500 mg/kg: Dermal effects ranged from very slight to slight on Day 1 and from absent to well-defined on Day 7.
- At 1000 mg/kg: Dermal effects ranged from absent to well-defined on Day 1 and from absent to very slight on Day 7.
- At 1500 mg/kg: Dermal effects ranged from absent to very slight on Days 1 and 7.
- At 2000 mg/kg: Dermal effects ranged from very slight to slight on Day 1 and from absent to very slight on Day 7. - Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- The LD50 of the test material is greater than 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- A single GLP study was available conducted on the target substance in vivo using a method equivalent to a guideline.
Additional information
The acute toxicity of the test substance via the oral route was assessed using a limit method similar to OECD Test Guideline 420 using a fixed dose procedure in rats. Five male rats were administered 1000 mg/kg via oral gavage. Animals were observed 1, 4 and 24 hours post-dose for mortality, toxicity and pharmacological effects. Mortality was recorded once daily thereafter for six days.
Two animals died during the test period; the first within 24 hours of administration, the second on Day 2. Pre-death observations included lethargy, wetness and red staining of the nose/mouth area, negative righting reflex, convulsions, spasms, tremors, unkempt appearance, few faeces, ataxia and wetness of the anogenital area.
Instances of lethargy, wetness and soiling of the anogenital area, wetness and red staining of the nose/mouth area, unkempt appearance and few faeces were noted early in the study in the survivors but they appeared normal from Day 4 through Day 7.
Based on the results of this test, the LD50 of the test material was >1000 mg/kg bw.
Two acute inhalation studies were performed on the read-across substance acrylamide.
The first was performed using a method equivalent to OECD Test Guideline 433 using a standard acute method. Six male rats were exposed to the aerosol (nose only) in a 160 L glass test chamber to 12 mg/m3 of the read-across material, acrylamide, for 1 hour. Observations of clinical signs and body weights were conducted for 14 days following exposure.
One animal died as a result of an infection unrelated to chemical exposure. No visible lesions could be attributed to the test material and there were no effects on body weights attributed to the test material. The results of this test indicate that the 50.7 % solution of the read-across material by the inhalation route has a 1 hour LC0 of 12 g/m3.
In a second study, performed to a method similar to OECD Test Guideline 433, rats were exposed to the read-across material, acrylamide, using a fixed dose procedure. Ten male rats were exposed to the read-across material using a nose-only exposure system for 6 hours at 16 mg/m3. Following exposure, the rats were observed for 24 hours after which gross necropsies were performed.
Following exposure by the inhalation route, there were no mortalities or systemic effects 16 mg/m3, which was the highest air concentration attainable. It can be concluded therefore that the LC0 for the test material in rats by inhalation is greater than 16 mg/m3.
The acute toxicity of the test substance via the dermal route was assessed using a method similar to OECD Test Guideline 402 using a standard acute method in New Zealand white rabbits. Rabbits were exposed to 500, 1000, 1500 or 2000 mg/kg for 24 hours on the back and sides covering approximately 10 % of the area of each rabbit’s skin, which had been clipped free of hair. The test material was applied under an occlusive or semi-occlusive dressing (highest dose level only). The test area was wiped, not washed, 24 hours after the start of exposure.
Animals dosed at 500 mg/kg were observed at 1, 5 and 24 hours post-dose. Animals dosed at 500 mg/kg were observed at 1, 4 and 24 hours post-dose and animals dosed at 1000, 1500 and 2000 mg/kg were observed at 1, 4 and 24 hours post-dose for mortality, toxicity and pharmacological effects. Animals were observed once daily thereafter for six days for mortality only. Body weights were recorded pre-test and at termination. The test sites were scored for dermal irritation at 24 hours post-dose and on day 7 using the Numerical Draize scoring code. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction. Additional signs were described.
All animals appeared normal at post-dose assessments up to 24 hours. Body weight changes were normal at all doses. The LD50 of the test material is therefore greater than 2000 mg/kg body weight.
Justification for classification or non-classification
The LD50 for exposure via the oral route was > 1000 mg/kg bw and the substance is therefore classified as Category 4 for acute exposure via the oral route.
The LC0 for exposure to the read across substance via the inhalation route was 12 mg/m3; acrylamide has a harmonised classification as Category 4 for acute exposure via the inhalation route.
The LD50 for exposure via the dermal route was > 2000 mg/kg bw and the substance is therefore not classified for acute exposure via the dermal route.
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