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EC number: 214-787-5 | CAS number: 1194-65-6
- 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
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 June 1987 to 06 September 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to other study
- Objective of study:
- metabolism
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 85-1 (Metabolism and Pharmacokinetics)
- Deviations:
- no
- GLP compliance:
- yes
- Radiolabelling:
- yes
- Species:
- rat
- Sex:
- male/female
- Route of administration:
- oral: unspecified
- Duration and frequency of treatment / exposure:
- Single dose or 11 daily doses
- Dose / conc.:
- 3.75 mg/kg bw/day
- Dose / conc.:
- 30 mg/kg bw/day
- Dose / conc.:
- 240 mg/kg bw/day
- Details on dosing and sampling:
- Samples originated from an earlier study: Scott et al. The excretion and retention of [14C]-dichlobenil in the rat following single and multiple oral administration. IRI project no: 136264. Report no. 4458 (The study is referenced as Cameron et al. (1988) in this IUCLID dataset).
For metabolite fingerprints, the 0-48 (single dose) and 240-288 (multiple dose) hours total urine samples were pooled separately for males and females (at the 3 dose levels). For faces, 0-24 or 0-48 and 240-264 or 240-288 hour samples were also pooled. For isolation and identification of metabolites, the 0-48 hour and 240-288 hour urine and faeces of the 240 mg/kg experiment were pooled. - Type:
- absorption
- Results:
- Readily absorbed.
- Type:
- excretion
- Results:
- Predominantly via the urine (more than 60 %), less than 25 % recovered in the urine
- Type:
- excretion
- Results:
- Repeat dosing did not affect excretion pattern
- Metabolites identified:
- yes
- Details on metabolites:
- The identification data revealed two major metabolic pathways:
- Hydroxylation at the 3 or 4 position (whether or not followed by glucoronidation or sulphation
- Substitution of one of the chlorine atoms by glutathione.
With multiple dosing, and especially at high dose levels, glutathion conjugation seems to be saturated. In the faeces, there was clear evidence that the contribution of conjugated compounds decreased with increased dose level in favour of the parent compound.
Different aspects of the metabolism of the test material in rats have been investigated in a number of individual studies. The most important results are as follows:
- The test material administered orally to rats is practically completely absorbed at doses of 5 mg/kg body weight.
- At dose levels up to 240 mg/kg absorption was at least 60 %.
- Urinary excretion was similar in a dose range of 3.75 to 240 mg/kg. There was no effect of sex or multiple dosing on total recovery or excretion pattern.
- After a single oral administration, highest concentrations in the organs and tissues were found between 1 and 3 hours after dosing. The highest level was found in the kidneys after 1 hour. At 24 hours, levels of radioactivity in organs had declined to less than 5 % of their respective peak levels.
Elucidation of metabolites in urine and faeces revealed two major metabolic pathways:
- Hydroxylation at the 3- or 4- position followed by glucoronidation or sulphation.
- Substitution of one of the chlorine-atoms in the course of glutathion conjugation.
The contribution of conjugated metabolites decreases with increasing doses. As a consequence harmful effects may increase above the limit of saturation of the conjugation pathways. - Conclusions:
- Under the conditions of this test, the elucidation of metabolites in urine and faeces revealed two major metabolic pathways:
- hydroxylation at the 3- or 4- position followed by glucoronidation or sulphatation; and
- substitution of one of the chlorine atoms in the course of gluthathion conjugation.
The contribution of the conjugated metabolites decreases with increasing dose. As a consequence, harmful effects may increase above the limit of saturation of the conjugation pathways. - Executive summary:
In a GLP compliant excretion and retention study conducted in line with standardised guideline EPA OPP 85-1, the excretion and retention of the test material was determined. The consideration of the metabolites from this study determined two major metabolic pathways:
- hydroxylation at the 3- or 4- position followed by glucoronidation or sulphation; and
- substitution at one of the chlorine-atoms in the course of gluthation conjugation.
The contribution of conjugated metabolites decreases with increasing dose. As a consequence, harmful effects may increase above the limit of saturation of the conjugation pathways.
Reference
Table 1: Cumulative excretion of radioactive material in urine and faeces
Dose | Excretion (% of dose) | |||||||
Sex | Number of animals | level (mg/kg) | Regime | Time | Urine | Time | Faeces | Total |
Male | 4 | 3.75 | Single | 0-48 | 65.4 | 0-24 | 16.2 | 81.6 |
Male | 4 | 3.75 | Multiple | 240-288 | 55.0 | 240-264 | 23.2 | 78.2 |
Female | 4 | 3.75 | Single | 0 48 | 67.4 | 0-24 | 16.9 | 84.3 |
Female | 4 | 3.75 | Multiple | 240-288 | 58.9 | 240-264 | 16.1 | 75.0 |
Male | 4 | 30 | Single | 0 -48 | 61.9 | 0-48 | 17.6 | 79.5 |
Male | 4 | 30 | Multiple | 240-288 | 62.4 | 240-288 | 18.0 | 80.3 |
Female | 4 | 30 | Single | 0-48 | 68.6 | 0-48 | 16.3 | 84.9 |
Female | 4 | 30 | Multiple | 240-288 | 58.1 | 240-288 | 20.8 | 79.0 |
Male | 4 | 240 | Single | 0-48 | 61.9 | 0-48 | 12.6 | 74.6 |
Male | 4 | 240 | Multiple | 240-288 | 50.5 | 240-288 | 24.0 | 74.5 |
Female | 4 | 240 | Single | 0-48 | 53.2 | 0-48 | 14.9 | 68.1 |
Female | 4 | 240 | Multiple | 240-288 | 46.1 | 240-288 | 18.9 | 64.9 |
Table 2: Inventory of the metabolites in urine
Metabolite (% of radioactivity in the pattern) | ||||||||||||
Dose (mg/kg) | Sex | Time (h) | A | B | C | D | E | F1 | F2 | G | H | I |
3.75 | M | 0-48 | 9 | 11 | 2 | 19 | 4 | 1 | 14 | 23 | 8 | 2 |
3.75 | F | 0-48 | 9 | 5 | 2 | 17 | 4 | 2 | 11 | 30 | 11 | 2 |
3.75 | M | 240-288 | 3 | 11 | 2 | 20 | 6 | 2 | 18 | 16 | 13 | 2 |
3.75 | F | 240-288 | 3 | 6 | 4 | 12 | 2 | 2 | 13 | 24 | 24 | 3 |
30 | M | 0-48 | 8 | 3 | 6 | 27 | 5 | 4 | 13 | 13 | 7 | 1 |
30 | F | 0-48 | 7 | 3 | 3 | 27 | 3 | 4 | 7 | 20 | 13 | 2 |
30 | M | 240-288 | 4 | 5 | 3 | 29 | 4 | 4 | 14 | 11 | 16 | 3 |
30 | F | 240-288 | 5 | 4 | 3 | 25 | 2 | 3 | 10 | 13 | 27 | 4 |
240 | M | 0-48 | 5 | 4 | 4 | 35 | 6 | 6 | 11 | 4 | 16 | 3 |
240 | F | 0-48 | 5 | 2 | 6 | 26 | 4 | 4 | 10 | 7 | 24 | 5 |
240 | M | 240-288 | 5 | 3 | 8 | 30 | 2 | 3 | 9 | 5 | 22 | 4 |
240 | F | 240-288 | 6 | 4 | 3 | 14 | 1 | 1 | 14 | 7 | 37 | 6 |
Table 3: Inventory of metabolites in faeces
Metabolite (% of radioactivity in the pattern) | ||||||
Dose (mg/kg) | Sex | Time (h) | D | F2 | H | J |
3.75 | M | 0-24 | 21 | 9 | 13 | 21 |
3.75 | F | 0-24 | 19 | 14 | 12 | 7 |
3.75 | M | 240-264 | 19 | 14 | 28 | 6 |
3.75 | F | 240-264 | 8 | 5 | 25 | 4 |
30 | M | 0-48 | 18 | 9 | 18 | 26 |
30 | F | 0-48 | 9 | 4 | 17 | 18 |
30 | M | 240-288 | 5 | 5 | 8 | 60 |
30 | F | 240-288 | 7 | 9 | 11 | 62 |
240 | M+F | 0-24 | 2 | - | 9 | 81 |
204 | M+F | 240-288 | - | - | 5 | 93 |
Description of key information
Different aspects of metabolism of the test material in rats have been investigated in a number of studies. There was no effect of sex or multiple dosing on total recovery or excretion pattern. After single oral administration, the highest concentration in the organs and tissues was found between one and three hours after dosing. The highest level was found in the kidney after one hour. At 24 hours, levels of radioactivity in organs had declined to less than 5 % of their respective peak levels.
Elucidation of metabolites in urine and faeces revealed two major metabolic pathways:
- hydroxylation at the 3 or 4 position followed by glucoronidation or sulphatation;
- substitution of one of the chloro-atoms in the course of glutathion conjugation.
The contribution of conjugated metabolites decreases with increasing dose. As a consequence, harmful effects may increase rapidly above the limit of saturation of the conjugation pathways. The test material is readily absorbed from the gastro-intestinal tract. Both the excretion and distribution show that the test material and/or its metabolites leave the body rapidly.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
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