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Diss Factsheets
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EC number: 231-901-9 | CAS number: 7778-39-4
- 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
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Epidemiological data
Administrative data
- Endpoint:
- epidemiological data
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles but with deviations: ecologic study and low number of participants
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
- Study type:
- cross sectional study
- Endpoint addressed:
- toxicity to reproduction / fertility
- Principles of method if other than guideline:
- Cross-sectional study was conducted on groups of 192 women (96/group) of reproductive age (15-49 years) who were chronically exposed to arsenic through drinking water to identify the pregnancy outcomes.
- GLP compliance:
- no
Test material
- Reference substance name:
- Arsenic
- EC Number:
- 231-148-6
- EC Name:
- Arsenic
- Cas Number:
- 7440-38-2
- IUPAC Name:
- arsine
- Details on test material:
- - Name of test material (as cited in study report): Arsenic-contaminated water
Constituent 1
Method
- Details on study design:
- METHOD OF DATA COLLECTION
- Type: Questionnaire
- Details: Questionnaire included information on the respondents’ lifetime pregnancy history, which included the number of pregnancies, preterm births (live birth before completion of 8 months, or 37 weeks from the last menstrual period), live births, stillbirths, and spontaneous abortions (spontaneous expulsion of product of conception before completion of 5 months, or 22 weeks of gestation from the last menstrual period).
STUDY POPULATION
- Selection criteria: Exposed group consisted of married women of reproductive age (15–49 years) who previously had at least one pregnancy and had been drinking arsenic-contaminated water (> 0.05 mg/L arsenic) for at least 5 years, whereas the nonexposed group consisted of respondents who had been drinking arsenic-safe water (i.e., < 0.02 mg/L arsenic).
- Total number of subjects participating in study: 96/group
- Sex/age/race: Female/15-49 years/Asian
- Matching criteria: Subjects in the nonexposed group were matched for age, socioeconomic status (SES), education, and age at marriage.
COMPARISON POPULATION
- Type: Regional registry: Exposed group: Residents of Samta village, Dhaka; unexposed group: Residents of Katiarchar village, Dhaka
- Details: Samta village: Avg. As level: 0.240 mg/L, highest concentration: 1.371 mg/L, prevalence of arsenicosis: 10% (52.6% male and 47.4% female); Katiarchar village: Avg. As level ≤ 0.02 mg/L
- See table 1 for more details
HEALTH EFFECTS STUDIED
- Mean number of pregnancies, stillbirths, preterm birth and spontaneous abortions - Exposure assessment:
- estimated
Results and discussion
- Results:
- FINDINGS
- Mean number of pregnancies, live births, stillbirths, spontaneous abortions and preterm births were 3.74, 3.33, 0.18, 0.23 and 0.23, respectively, among the exposed group and 3.22, 3.07, 0.07, 0.07 and 0.08, respectively, in the nonexposed group.
- In exposed and nonexposed groups, respectively, 89.1 and 95.5% of pregnancies ended as live births.
- Adverse pregnancy outcomes measured as spontaneous abortions, stillbirths and preterm birth rates were 68.8, 53.1 and 68.8 per 1000 live births, respectively, among the exposed group and
23.7, 23.7 and 27.1 per 1000 live births, respectively, among the nonexposed group.
- See table 2-4 for more details - Confounding factors:
- No information on specific confounding factors but both populations have comparable intrinsic structure (age, socio economic status, education).
- Strengths and weaknesses:
- Limitations
- Small sample size.
- Rudimentary medical records system and tests for confirmation of pregnancy were rarely available in the rural areas.
- Limited information on confounding factors
- No age comparison between more and less than 15 years exposure.
Any other information on results incl. tables
Table 2. Respondents by mean pregnancy outcomes
Pregnancy outcome |
Exposed |
Nonexposed |
Pregnancy |
3.74 ± 1.8 (359) |
3.22 ± 1.6 (309) |
Live birth |
3.33 ± 1.6 (320) |
3.07 ± 1.6 (295) |
Stillbirth |
0.18 ± 0.69 (17) |
0.07 ± 0.33 (7) |
Spontaneous abortion |
0.23 ± 0.57 (22) |
0.07 ± 0.36 (7) |
Preterm birth |
0.23 ± 0.55 (22) |
0.08 ± 0.28 (8) |
Table 3. Adverse pregnancy outcomes per 1000 live births among the respondents.
Pregnancy outcome |
Exposed |
Nonexposed |
z-Score |
p-Value |
Spontaneous abortion |
68.8 |
23.7 |
2.66 |
0.008 |
Stillbirth |
53.1 |
23.7 |
2.00 |
0.046 |
Preterm birth |
68.8 |
27.1 |
2.35 |
0.018 |
Table 4. Adverse pregnancy outcome rates (per 1000 live births) by duration of drinking arsenic contaminated (> 0.1 mg/L) water
|
Duration of drinking arsenic-contaminated water |
|||
Pregnancy outcome |
< 15 Years |
≥ 15 Years |
z-Score |
p-Value |
Spontaneous abortion |
43.5 |
133.3 |
3.0 |
0. 003 |
Stillbirth |
43.5 |
77.5 |
2.0 |
0.046 |
Preterm birth |
47.8 |
122.2 |
2.3 |
0.021 |
Applicant's summary and conclusion
- Conclusions:
- Under the studied conditions, chronic exposure to arsenic through drinking water produced adverse pregnancy outcomes in women.
- Executive summary:
A cross-sectional study was conducted on groups of 192 women (96/group) of reproductive age (15-49 years) who were chronically exposed to arsenic through drinking water to identify the pregnancy outcomes in terms of live birth, stillbirth, spontaneous abortion, and preterm birth. Women in both exposed and nonexposed groups were matched for age, socioeconomic status, education and age at marriage. Of the respondents in the exposed group, 98% had been drinking water containing ≥ 0.10 mg/L arsenic and 43.8% had been drinking arsenic-contaminated water for 5-10 years.
Skin manifestation due to chronic arsenic exposure was present in 22.9% of the respondents from the exposed group. Adverse pregnancy outcomes in terms of spontaneous abortion (only for difference between more and less than 15 years exposure), stillbirth and preterm birth rates were determined to be significantly higher in the exposed group than those in the nonexposed group.
Under the studied conditions, chronic exposure to arsenic through drinking water in a population where most well are measured between 200 to 450 µg/L produced an increased incidence of adverse pregnancy outcomes when compared to groups exposed to less than 20 µg/L.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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