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EC number: 202-491-9 | CAS number: 96-23-1
- 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
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- Nanomaterial pour density
- Nanomaterial photocatalytic activity
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- Endpoint summary
- Stability
- Biodegradation
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- 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
Carcinogenicity
Administrative data
Description of key information
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has assessed the carcinogenicity data from a 2 year drinking water study in Wistar Rats using Benchmark dose analysis. They concluded that the BMDL10 for tumour incidence was 3.3 mg/kg bw/day. This value has been taken forward to calculate the DMEL for the substance.
In addition both the European Commission and IARC have designated the substance as a known carcinogen in animals with possible carcinogenicity in humans.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- The paper presents the BMDL10 values calculated for the substance based upon the results of a 2 year carcinogenicity study conducted in rats.
- GLP compliance:
- no
- Remarks:
- GLP status is not appplicable to review documents
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- Wistar KFM/Han
- Sex:
- male/female
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Dose / conc.:
- 27 mg/L drinking water
- Dose / conc.:
- 80 mg/L drinking water
- Dose / conc.:
- 240 mg/L drinking water
- No. of animals per sex per dose:
- 80 (eighty)
- Control animals:
- yes, concurrent vehicle
- Key result
- Dose descriptor:
- BMDL10
- Effect level:
- ca. 3.3 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: tumour incidence
- Dose descriptor:
- BMD: 10
- Effect level:
- ca. 5.4 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: tumour incidence
- Conclusions:
- The Committee concluded that the critical effect of 1,3-dichloro-2-propanol
is carcinogenicity. The substance yielded negative results in two new studies of
genotoxicity, a test for micronucleus formation in bone marrow in vivo and an assay
for unscheduled DNA synthesis in vivo/in vitro in rat hepatocytes, but limitations in
those studies and positive findings in tests for genotoxicity in vitro as well as lack of
knowledge on the modes of action operative at the various tumour locations led the
Committee to the conclusion that a genotoxic mode of action could not be excluded.
Accordingly, the cancer dose–response data were analysed by dose–response
modelling, and the Committee used eight different models to calculate BMD
10 and BMDL10 values. BMDL10 values for the individual tumours ranged from 7.2 to
19.1 mg/kg bw per day and for incidence data on tumour-bearing animals for all
treatment-affected locations from 3.3 to 7.7 mg/kg bw per day. - Endpoint:
- carcinogenicity: oral
- Type of information:
- other: IARC monograph
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Review of available genotoxicity and carcinogenicity data
- GLP compliance:
- no
- Remarks:
- no required for review documents
- Conclusions:
- Based upon the evidence provided the Working Group concluded that there was sufficient evidence in experimental animals for the carcinogenicity of 1,3-dichloro-2-propanol. 1,3-dichloro-2-propanol is possibly carcinogenic to humans (Group 2B) .
Referenceopen allclose all
BMD10s and BMDL10s varied within the range of 5.4 to 7.5 and 3.3 to 6.1 mg/kg
bw per day, respectively. This proves the required independency of results from the
chosen model. Modelling for malignant tumours only gave similar results (not
shown) with BMD10 and BMDL10 ranges of 8.3 to 10.1 mg/kg bw per day and 5.6 to
8.4 mg/kg per day, respectively.
Modelling results for female rats (animals with treatment-related tumours)
are shown in Table 4. As for male rats, several models gave reasonable fits and
BMD10s and BMDL10s varied only within a narrow range: the ranges obtained were
7.6 to 10.3 mg/kg bw per day for BMD10 and 6.6 to 7.7 mg/kg bw per day for BMDL10.
Table 5 gives a summary of the modelling of data for individual tumour sites.
Modelling was performed on incidence data for tumour-bearing animals for benign
and malign kidney tumours (males only), hepatocellular tumours (males and
females) as well as tumours of the tongue (males and females) (see Table 1 and 2 for
incidence data for males and females, respectively). Incidence data for thyroid
tumours showed no clear dose–response relationship and were unsuitable for
modelling.
Table 1. Number of male rats bearing tumours after receiving drinking-water
containing 1,3-dichloro-2-propanol for 2 years
Tumour site Concentration (mg/kg)
0 2.1 6.3 19
Kidney
Tubular adenoma 0/50 0/50 3/50 9/50
Tubular carcinoma 0/50 0/50 0/50 1/50
Combined 0/50 0/50 3/50 9/50a
Liver
Hepatocellular 1/50 0/50 0/50 0/50
adenoma
Hepatocellular 0/50 0/50 2/50 8/50
carcinoma
Combined 1/50 0/50 2/50 8/50
Thyroid gland
Follicular adenoma 0/50 0/50 2/50 3/48
Follicular carcinoma 0/50 0/50 2/50 1/48
Combined 0/50 0/50 4/50 4/48
Tongue
Papilloma 0/50 1/50 0/49 6/50
Carcinoma 0/50 0/50 0/49 6/50
Combined 0/50 1/50 0/49 12/50
All treatment-affected sites: kidney tubular adenoma and carcinoma, hepatocellular
adenoma and carcinoma, follicular adenoma and carcinoma of the thyroid, papilloma and
carcinoma of the tongue
Benign tumours 1/50 1/50 5/50 17/50
Malign tumours 0/50 0/50 4/50 14/50
Combined 1/50 1/50 8/50b 29/50c
a Male No. 274 had an adenoma and a carcinoma and was counted only once
b Male No. 201 had a benign and a malign tumour and was counted only once
c Males Nos 269 and 274 each had a benign and a malign tumour; both animals were counted
only once
Table 2. Number of female rats bearing tumours after receiving drinking-water
containing 1,3-dichloro-2-propanol for 2 years
Tumour site Concentration (mg/kg)
0 3.4 9.6 30
Liver
Hepatocellular 1/50 1/50 1/50 5/50
adenoma
Hepatocellular 0/50 0/50 1/50 36/50
carcinoma
Combined 1/50 1/50 2/50 41/50
Thyroid gland
Follicular adenoma 1/50 0/50 3/50 3/49
Follicular carcinoma 0/50 0/50 0/50 2/49
Combined 1/50 0/50 3/50 5/49
Tongue
Papilloma 0/50 0/50 0/50 7/49
Carcinoma 0/50 1/50 1/50 4/49
Combined 0/50 1/50 1/50 11/49
All treatment-affected sites: hepatocellular adenoma and carcinoma, follicular adenoma and
carcinoma of the thyroid, papilloma and carcinoma of the tongue
Benign tumours 2/50 1/50 4/50 12/50
Malign tumours 0/50 1/50 2/50 37/50
Combined 2/50 2/50 6/50 42/50a
aSeveral animals had both benign and malign tumours and were counted only once.
Table 3. BMD10, BMDL10 and statistical parameters obtained from fitting
models to dose–response data for male rats with treatment-related tumours
after receiving drinking-water containing 1,3-dichloro-2-propanol for 2 years
Model pvalue Chi squared AIC BMD10(mg/kg BMDL10(mg/kg
bw per day) bw per day)
Gamma 0.507 0.44 138.1 5.4 3.5
Logistic 0.248 2.79 138.5 7.5 6.1
Logistic (log dose) .534 0.39 138.0 5.4 3.5
Probit 0.366 2.01 137.7 6.8 5.6
Probit (log dose) 0.731 0.12 137.7 5.4 3.6
Quantal-quadratic 0.493 1.42 136.9 6.5 5.6
Weibull 0.620 0.43 138.3 5.4 3.4
Multistage (2nd 0.343 0.90 138.6 5.7 3.3
degree polynomial,
betas>=0)
AIC: Akaike’s information criterion; BMD10: benchmark dose for 10% extra risk of tumours;
BMDL10: 95% lower confidence limit for the benchmark dose. Extra risk is defined as the
additional incidence divided by the tumour-free fraction of the population in the controls.
Multistage stands for a specific mathematical model applied.
Table 4. BMD10, BMDL10and statistical parameters obtained from fitting
models to dose–response data for female rats with treatment-related tumours
after receiving drinking-water containing 1,3-dichloro-2-propanol for 2 years
Model pvalue Chi-squared AIC BMD10 BMDL10
(mg/kg bw (mg/kg bw
per day) per day)
Gamma 0.967 0.00 120.2 10.2 7.2
Logistic 0.810 0.42 118.6 9.4 7.5
Logistic (log dose) 0.953 0.00 120.3 10.1 7.4
Probit 0.588 1.06 119.2 8.5 6.9
Probit (log dose) 0.996 0.00 120.2 10.1 7.7
Quantal-quadratic 0.41 1.77 120.1 7.6 6.7
Weibull 0.888 0.02 120.3 10.3 7.0
Multistage (3rd 0.854 0.03 120.3 10.3 6.6
degree polynomial,
betas 0)
AIC: Akaike’s information criterion; BMD10: benchmark dose for 10% extra risk of tumours.
BMDL10: 95% lower confidence limit for the benchmark dose. Extra risk is defined as the
additional incidence divided by the tumour-free fraction of the population in the controls.
Table 5. Result of dose–response modelling (BMD10, BMDL10) for various
treatment-affected tumour sites for male and female rats receiving drinking-
water containing 1,3-dichloro-2-propanol for 2 years
Tumour site and type Models with Range of BMD10s Range of BMDL10s
acceptable fits (mg/kg bw per day) (mg/kg bw per day)
Males
Renal adenoma and Gamma, log logistic, 11.1–12.2 7.2–7.7
Carcinoma log probit, Weibull,
Multistage
Hepatocellular adenoma Logistic, probit, log 14.4–16.0 10.3–12.3
and carcinoma probit, quantal-quadr.,
multistage
Tongue papilloma and Gamma, logistic, log 12.4–17.9 8.7–11.6
Carcinoma logistic, probit, log
probit, quantalquadratic,
Weibull,multistage
Females
Hepatocellular adenoma Gamma, logistic, log 11.2–14.6 9.1–10.1
and carcinoma logistic, probit, log
probit, Weibull,
multistage
Tongue papilloma and Gamma, logistic, log 17.1–22.8 11.5–19.1
Carcinoma logistic, probit, log
probit, quantalquadratic,
Weibull, multistage
BMD10: benchmark dose for 10% extra risk of tumours. BMDL10: 95% lower confidence limit
for the benchmark dose. Extra risk is defined as the additional incidence divided by the
tumour-free fraction of the population in the controls.
Table 10. BMD10aand BMDL10bvalues obtained from fitting models to
incidence data for all treatment-related tumours and for individual tumour
locations in male and female rats given drinking water containing 1,3dichloro-2-propanol
for 2 years
Treatment-affected sites and Range of BMD10values Range of BMDL10values
tumour types (mg/kg bw per day) (mg/kg bw per day)
Males
Tumour-bearing animals/all 5.4–7.5 3.3–6.1
treatment-associated sites
Renal adenoma and carcinoma 11.1–12.2 7.2–7.7
Hepatocellular adenoma and 14.4–16.0 10.3–12.3
carcinoma
Tongue papilloma and carcinoma 12.4–17.9 8.7–11.6
Females
Tumour-bearing animals/all 8.5–10.3 6.6–7.7
treatment-associated sites
Hepatocellular adenoma and 11.2–14.6 9.1–10.1
carcinoma
Tongue papilloma and carcinoma 17.1–22.8 11.5–19.1
aBMD10: benchmark dose for 10% extra risk of tumours.
bBMDL10: 95% lower confidence limit for the benchmark dose. Extra risk is defined as the
additional incidence divided by the tumour-free fraction of the population in the controls.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- BMDL10
- 3.3 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- System:
- other: tumor incidence
- Organ:
- other: tumor incidence
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The substance has a harmonised classification (Index number: 602 -064 -00 -0) of Carcinogen Category 1B H35): may cause cancer.
Additional information
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