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EC number: 227-177-9 | CAS number: 5698-98-6
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- other: Experimental study with acrylic acid (structural analogue) which is used for read-across (see attached read across justification document in IUCLID section 13)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well-documented study report, comparable to guideline study with acceptable restrictions. Justification for read-across: similar chemical structure (see Cemical Safety Report)
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
- Reference Type:
- publication
- Title:
- Subchronic and Reproductive Toxicology Studies on Acrylic Acid in the Drinking Water of the Rat.
- Author:
- DePass L. R. et al.
- Year:
- 1 983
- Bibliographic source:
- Drug and Chemical Toxicology 6: 1-20
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
- Principles of method if other than guideline:
- 10 male and 20 female rats per group were administered acrylic acid at dosage goals of 0, 83, 250 and 750 mg/kg/bw/day in drinking water. At the end of 13 weeks, the male and female rats from each group were mated one male to two females for a 15-day period. Females were introduced into male cages. Rats ware assigned to treatment groups using a computer generated random number scheme. The F0 generation rats were sacrificed after weaning of the F1 generation and were approximately 194 days old at the time of sacrifice. The F1 generation rats were sacrificed at 21 days of age. Treatment effects were determined by statistical comparison of mortality, body weight change, food and water consumption, organ weight change and histological evaluation of tissues from sacrificed animals.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Acrylic acid
- EC Number:
- 201-177-9
- EC Name:
- Acrylic acid
- Cas Number:
- 79-10-7
- IUPAC Name:
- acrylic acid
- Details on test material:
- - Name of test material (as cited in study report): Acrylic acid
- Analytical purity: 97.8%
- Lot No.: 42-19
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Microbiological Associates, Inc., Walkersville, MD.
- Age at study initiation: (P): 41 days
- Weight at study initiation: (P) Males: 111-139 g; Females: 85-118 g
- Housing: During mating, two females were placed in a cage with one male; at this time all rats received acrylic acid at the concentration in the water for the respective female groups. Fifteen days after the first mating, cohabitation was discontinued and the individual females were placed in plastic cages fitted with wire rod metal tops. Ab-sorb-dri hardwood chips were used for bedding in the plastic cages.
- Diet (ad libitum): Zeigler Brothers NIH-07
- Water (ad libitum): Tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Photoperiod (hrs dark / hrs light): no data
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on mating procedure:
- - M/F ratio per cage: 1/2
- Length of cohabitation: 15 days
- After successful mating each pregnant female was caged (how): Fifteen days after the first mating, cohabitation was discontinued and the individual females were placed in plastic cages fitted with wire rod metal tops. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The stability of aqueous solutions of acrylic acid was determined using a gas chromatographic procedure. The mean dosage levels attained were quite close to the dosage goals for each group. The mean overall dosages of acrylic acid were 0.73, 0.25 and 0.085 g/kg/bw/day for males and 0.72,
0.25 and 0.083 g/kg/bw/day for females. - Duration of treatment / exposure:
- Exposure period: 13 weeks
before the mating and afterwards during the gestation and lactation periods.
Premating exposure period (males): 13 weeks
Premating exposure period (females): 13 weeks
Duration of test: approx. 6 months - Frequency of treatment:
- continuously
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 83, 250, 750 mg/kg bw/d
Basis:
nominal in water
- No. of animals per sex per dose:
- 10 males and 20 females
- Control animals:
- yes, concurrent vehicle
- Positive control:
- none
Examinations
- Parental animals: Observations and examinations:
- DETAILED CLINICAL OBSERVATIONS:
Daily observation for clinical signs
BODY WEIGHT:
Individual body weights for each F0 animal were determined weekly.
FOOD CONSUMPTION:
The food consumption rate was recorded weekly. Fresh diet was added to the jars every week.
WATER CONSUMPTION:
The water consumption rate was recorded weekly. Fresh solutions were prepared each week, with the percentage of acrylic acid in the water (X) adjusted to maintain a relatively constant dosage level (K) in g/kg according to formula:
X = 100 KW / G
Where X and K are explained above:
W = predicted mean body weight, kg
G = mean water consumption, ml - Oestrous cyclicity (parental animals):
- not examinated
- Sperm parameters (parental animals):
- not examinated
- Litter observations:
- PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical or behavioural abnormalities. - Postmortem examinations (parental animals):
- SACRIFICE
Five male and five female rats, randomly selected from each dosage level of the F0 parents, were anesthetized with methoxyflurane and sacrificed by severing the brachial vesseis to permit exsanguination.
GROSS NECROPSY
- All sacrificed rats were given a complete gross necropsy examination and organ weights were recorded for the liver, kidneys, heart, spleen, brain and testes.
HISTOPATHOLOGY / ORGAN WEIGHTS
The following tissues were taken and fixed in 10% neutral buffered formalin, processed for paraf in embedding, sectioned at 5 microns and stained with hematoxylin and eosin on all high dose and control animals. Only those tissues with gross lesions were examined microscopically from the intermediate and low level animals.
Pituitary, thyroids, parathyroids, adrenals, heart, thymus, spleen, testes, epididymides, kidneys, urinary bladder, tongue, submandibular salivary gland, esophagus, stomach, duodenum, colon, mesenteric lymph node, nasal cavity, trachea, lungs, ovaries, oviduct, liver, pancreas, brain, eyes, skin, mammary gland, sternum, any lesions. - Postmortem examinations (offspring):
- SACRIFICE
Five male and five female rats, randomly selected from each dosage level of the F1 weanlings, were anesthetized with methoxyflurane and sacrificed by severing the brachial vesseis to permit exsanguination.
GROSS NECROPSY
- All sacrificed rats were given a complete gross necropsy examination and organ weights were recorded for the liver, kidneys, heart, spleen, brain and testes.
HISTOPATHOLOGY / ORGAN WEIGHTS
The following tissues were taken and fixed in 10% neutral buffered formalin, processed for paraf in embedding, sectioned at 5 microns and stained with hematoxylin and eosin on all high dose and control animals. Only those tissues with gross lesions were examined microscopically from the intermediate and low level animals.
Pituitary, thyroids, parathyroids, adrenals, heart, thymus, spleen, testes, epididymides, kidneys, urinary bladder, tongue, submandibular salivary gland, esophagus, stomach, duodenum, colon, mesenteric lymph node, nasal cavity, trachea, lungs, ovaries, oviduct, liver, pancreas, brain, eyes, skin, mammary gland, sternum, any lesions. - Statistics:
- For every experimental parameter or index measured, the results of each of the three test levels were compared with the control group. To evaluate the statistical significance of possible changes in continuous data, the analysis of variance (ANOV) validated by Bartlett's test for homogeneity of variance, was used. Individual mean differences were identified by Duncan's multiple range test when indicated by a significant F value for ANOV. In the case of heterogeneous variances, as indicated by Bartlett's test, the paired group F test, and either the Cochran or the Student t-test were used to identify significant differences. Enumerative data were evaluated statistically by NXR Chi Square test; differences between groups were delineated by Fisher's Exact test. Non-parametric data were compared by a distribution-free multiple comparison method. The fiducial limit of 0.05 was employed as the critical level of difference not attributable to chance
- Reproductive indices:
- The following reproductive parameters were evaluated statistically:
1. Fertility index - the proportion of females that were pregnant of the number that were mated or the proportion of the males shown to be fertile of the number that were mated.
2. Gestation Index - the proportion of pregnancies that resulted in litters with live pups.
3. Gestation Survival Index - the proportion of newborn pups that were alive at birth.
4. Pups born alive per litter.
5. Days from mating to litter. - Offspring viability indices:
- The following reproductive parameters were evaluated statistically:
1. 5-Day Survival Index - the proportion of liveborn that survived 5 days.
2. 21-Day Survival Index - the proportion of pups retained on day 5 that survived 21 days.
3. Pups weaned per pups alive at birth.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- effects observed, treatment-related
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- effects observed, treatment-related
Details on results (P0)
There were no significant abnormal clinical signs observed. No deaths occurred during the study.
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS):
Body weight gain was depressed markedly for both sexes at the high dosage level. This effect was statistically highly significant in these groups throughout the study. At the highest dosage level there were effects on diet and water consumption, body weight gain and organ weights (liver, kidneys, spieen, testes, brain). At the intermediate dosage level, a decrease in water consumption was noted for both sexes. Body weight gain was reduced while liver and kidney weights (absolute and/or relative) were increased for the female rats. At the lowest dosage level, absolute liver and kidney weights and relative liver weights were increased for the females. These changes were possibly chemically induced.
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS):
At the highest dose, a numerical reduction of the fertility (male and female) and gestation indices, pups born alive and pups weaned was observed.
ORGAN WEIGHTS (PARENTAL ANIMALS):
The effect of acrylic acid on the organ weights was obvious at the high dosage level in both sexes. In the male rats this effect included: Significant reduction in absolute liver weight and significant increase in relative kidney, spleen and testes weights.
In the female rats, the effects on organ weights at the high dose level included: Significant reduction in absolute liver and spleen weights and significant increase in relative kidney and brain weights. Furthermore, the significant increases in relative liver weight and absolute and relative kidney weights for the intermediate level females are considered to be dose-related effects. The significant increase in absolute liver and kidney weights and relative liver weights in the lowest dosage level females are possibly chemically-induced changes. However, the significant increase in female fertility in this group precludes the probability that reproductive behavior was affected by these changes. They are, therefore, considered to be of no biological importance on reproduction.
GROSS PATHOLOGY (PARENTAL ANIMALS):
There were no gross lesions which could be attributed to treatment with acrylic acid.
HISTOPATHOLOGY (PARENTAL ANIMALS):
Histopathological examination revealed no treatment-related lesions associated with the ingestion of acrylic acid.
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 83 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: Body and organ weights.
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: fertility index; gestation index
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Details on results (F1)
There were no significant abnormal clinical signs observed. There were no consistent findings in the spontaneous death of neonatal rats.
BODY AND ORGAN WEIGHT (OFFSPRING)
The effects at the highest dosage level of the parent generation were similar to those observed for the highest dosage level of the progeny. Here
also, there were effects on body weight gain and organ weights (liver, heart, kidneys, brain, spleen).
GROSS PATHOLOGY (OFFSPRING):
There were no gross lesions which could be attributed to treatment with acrylic acid.
HISTOPATHOLOGY (OFFSPRING)
Histopathological examination revealed no treatment-related lesions associated with the ingestion of acrylic acid.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 250 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: Pup body and organ weights; number of pups born alive and pups weaned
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Mean body weight changes (g)
Week of treatment |
0 mg/kg/bw/d |
83 mg/kg/bw/d |
250 mg/kg/bw/d |
750 mg/kg/bw/d |
||||
male |
female |
male |
female |
male |
female |
male |
female |
|
Mean bw at day 0 |
124.5 |
99.4 |
124.0 |
101.3 |
125.3 |
102.4 |
121.4 |
99.0 |
1 |
29.8 |
12.7x |
28.6 |
14.2 |
31.2 |
13.8x |
24.1a |
10.6a |
2 |
62.2 |
26.8 |
56.8 |
27.6 |
63.1 |
23.5a |
51.3b |
21.4c |
3 |
89.2 |
37.6 |
83.4 |
38.1 |
91.7 |
36.6 |
75.7b |
30.0c |
4 |
112.2 |
47.6 |
106.5 |
46.7 |
111.1 |
45.4 |
93.6b |
36.9c |
5 |
130.3 |
55.6 |
126.7 |
55.8 |
128.6 |
52.5 |
106.7b |
41.6c |
6 |
145.3 |
63.6 |
142.2 |
63.8 |
141.8 |
58.6a |
119.0c |
47.2c |
7 |
159.5 |
69.4 |
154.2 |
70.3 |
153.0 |
63.6a |
127.8c |
49.8c |
8 |
171.8 |
73.3 |
167.7 |
74.1 |
162.6 |
67.1a |
125.6c |
52.1c |
9 |
181.1 |
75.9 |
176.4 |
77.2 |
170.1 |
69.2a |
131.6c |
53.0c |
10 |
191.4 |
79.9 |
187.6 |
81.0 |
180.0 |
73.3a |
139.2c |
55.2c |
11 |
200.1 |
82.4 |
194.9 |
83.3 |
185.4 |
74.5b |
142.8c |
57.4c |
12 |
205.2 |
84.4 |
200.6 |
86.0 |
191.7 |
78.0a |
144.7c |
58.6c |
a0.05>p>0.01
b0.01>P>0.001
cP<0.001
xOne clinically ill rat excluded from statistical evaluation of body weight gain.
Reproductive Performance
Parameter |
Dose (mg/kg/bw/d |
|||
0 |
83 |
250 |
750 |
|
Fertility index (males)a |
80 |
100 |
80 |
60 |
Fertility index (female)b |
50 |
95 |
75 |
45 |
Gestation indexc |
100 |
100 |
100 |
89 |
Gestation survival indexd |
100 |
100 |
100 |
100 |
5-Day survival indexe |
100 |
100 |
100 |
100 |
21-Day survival indexf |
100 |
100 |
100 |
100 |
Pups born alive/Litterg |
6 |
8 |
9 |
4 |
Pups weaned/Pups alive at birth (100)g |
100 |
100 |
100 |
42 |
aLitters sired per males mated x 100
bDeliveries per females mated x 100
cLitters with live pups/total pregnancies x 100
dPups born viable/total pups delivered x 100, median per litter
ePups viable at day 5/pups born viable x 100, median per litter
fPups viable on day 21/pupe retained at day 5 x 100, median per litter
gMedians
Applicant's summary and conclusion
- Conclusions:
- 10 male and 20 female rats per group were administered acrylic acid at dosage goals of 0, 83, 250 and 750 mg/kg/bw/day in drinking water. At the end of 13 weeks, the male and female rats from each group were mated one male to two females for a 15-day period. Females were introduced into male cages. The F0 generation rats were sacrificed after weaning of the F1 generation and were approximately 194 days old at the time of sacrifice. The F1 generation rats were sacrificed at 21 days of age. Deleterious effects were observed at the high dosage level (750 mg/kg/bw/day) in both sexes for parents and progeny. These effects included diet and water consumption, body and organ weight changes. Furthermore, there was a numerical reduction in the fertility and gestation indices and the number of pups weaned. At the intermediate level, although the reproductive parameters were equivalent to those of the controls, dosage-related effects were seen for water consumption and body and organ weights in the parent rats. At the low dosage level, organ weight changes observed in the female rats of the parent generation are considered to be of minimal biological significance. In summary, although numerous treatment-related effects were observed at the two highest dosage levels, many of these may be the result of reduced food and water consumption rather than specific toxic effects of acrylic acid. At the highest dosage level, the preponderance of statistical significance in many parameters in both parents and progeny concomitant with generally lowered reproductive indices is a clearly dose-related toxic effect. Therefore, based on the above findings the maximum dosage level that did not produce a deleterious reproductive effect for one generation of exposure of acrylic acid in the drinking water of rats was estimated to be 250 mg/kg bw/day.
- Executive summary:
10 male and 20 female rats per group were administered acrylic acid at dosage goals of 0, 83, 250 and 750 mg/kg/bw/day in drinking water. At the end of 13 weeks, the male and female rats from each group were mated one male to two females for a 15-day period. Females were introduced into male cages. Rats ware assigned to treatment groups using a computer generated random number scheme. The F0 generation rats were sacrificed after weaning of the F1 generation and were approximately 194 days old at the time of sacrifice. The F1 generation rats were sacrificed at 21 days of age. Treatment effects were determined by statistical comparison of mortality, body weight change, food and water consumption, organ weight change and histological evaluation of tissues from sacrificed animals.
Deleterious effects were observed at the high dosage level (750 mg/kg/bw/day) in both sexes for parents and progeny. These effects included diet and water consumption, body and organ weight changes. Furthermore, there was a numerical reduction in the fertility and gestation indices and the number of pups weaned. At the intermediate level, although the reproductive parameters were equivalent to those of the controls, dosage-related effects were seen for water consumption and body and organ weights in the parent rats.
At the low dosage level, organ weight changes observed in the female rats of the parent generation are considered to be of minimal biological significance.
The results of the reproduction study do not indicate a substantial deleterious effect of acrylic acid on reproductive performance, since there were no statistically significant differences among the treated and control groups.
In summary, although numerous treatment-related effects were observed at the two highest dosage levels, many of these may be the result of reduced food and water consumption rather than specific toxic effects of acrylic acid.
At the highest dosage level, the preponderance of statistical significance in many parameters in both parents and progeny concomitant with generally lowered reproductive indices is a clearly dose-related toxic effect. Therefore, based on the above findings the maximum dosage level that did not produce a deleterious reproductive effect for one generation of exposure of acrylic acid in the drinking water of rats was estimated to be 250 mg/kg bw/day.
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