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EC number: 204-428-0 | CAS number: 120-82-1
- 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
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with restrictions
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Assessment of teratogenic potential of 1,2,3-1,2,4-and 1,3,5-trichlorobenzene in rats
- Author:
- Black WD
- Year:
- 1 988
- Bibliographic source:
- Bull. Environ. Contam. Toxicol.41: 719 - 726
- Reference Type:
- publication
- Title:
- A teratological evaluation following oral administration of TCB and DCB isomers
- Author:
- Ruddick JA et al
- Year:
- 1 983
- Bibliographic source:
- Teratology 27, 73A - 74A
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- Housing and feeding conditions not reported; exposure too short; numberof animals exposed too small; weight of dams recorded only at 22nd day of gestation; food consumption, number of corpora lutea , sex of each foetus not recorded.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 1,2,4-trichlorobenzene
- EC Number:
- 204-428-0
- EC Name:
- 1,2,4-trichlorobenzene
- Cas Number:
- 120-82-1
- Molecular formula:
- C6H3Cl3
- IUPAC Name:
- 1,2,4-trichlorobenzene
- Details on test material:
- - Name of test material (as cited in study report): 1,2,4-trichlorobenzene
- Analytical purity: > 99.5%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Woodlyn farm Laboratories, Guelph, Ontario
- Weight at study initiation: 175-122 g
- Housing: Mated females were housed in wire-top plastic cages containing cob bedding
- Acclimation period: 1 week prior mating
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/2
- Length of cohabitation: overnight
- Proof of pregnancy: vaginal swabs. The morning on which sperm was detected in the female was designed as day 1 pregnancy.
- Any other deviations from standard protocol - Duration of treatment / exposure:
- day 6 to 15 of gestation
- Frequency of treatment:
- daily
- No. of animals per sex per dose:
- Each groups consisted of approximately 14 dams
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: No
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: on the 22nd day of gestation
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 22
- Organs examined: uterus (transacted anterior to the cervix and removed with the ovaries), liver, kidney, spleen, heart and brain were removed and weighed
OTHER:
-HEMATOLOGY: maternal blood was hematologically analyzed using a Baler 700. The following parameters were measured: haemoglobin concentration, hematocrit value, erythrocyte count, total and differential counts of leucocytes, mean corpuscular volume, mean corpuscular haemoglobin concentration and mean corpuscular haemoglobin.
- BLOOD CHEMISTRY: serum from each dam was analyzed and the following parameters were analyzed: sodium, potassium, inorganic phosphorus, total bilirubin, alkaline phosphatise, glutamic oxaloacetic transaminase (GOT), total protein, calcium cholesterol, glucose, uric acid and lactic dehydrogenase (LDH).
-RESIDUE ANALYSIS: maternal tissues were selected for 1,2,4-trichlorobenzene residue analysis
-HISTOLOGICAL ANALYSIS: was performed on heart, brain, pituitary, eye, thyroid, parathyroid, trachea, bronchi, kidney, lung, thymus, stomach, small and large intestine, pancreas, liver, kidney, spleen, adrenal, skeletal muscle, peripheral nerve, skin, bone marrow, ovary, uterus, and bladder tissues. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: No
- Number of implantations: No
- Number of resorptions: Yes - Fetal examinations:
- - External examinations: Yes
- Soft tissue examinations: Yes: one third
- Skeletal examinations: Yes: two thirds of each litter
- Head examinations: No - Statistics:
- The data from organ weight, body weights, haematology, and biochemistry were subjected to a simple one way analysis of variance. When significant differences (p< 0.05) were indicated, the Duncan´s Multiple Range Test (SPSS version 8.1) selected the groups that were significantly different.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Post-mortem examination showed slight liver changes (increased periportal cytoplasmic
eosinophilia and slight anisokeryosis of the cell nuclei of the hepatocytes) in dams dosed with
150 mg/kg bw/day. In addition to these effects, a significant 5.7% increase in relative liver weight was seen in the 300 mg/kg dose group; the absolute liver weight was also significantly increased, but the weights of other organs were statistically normal. Changes in the thyroid gland were also observed in the 300 mg/kg 1,2,4-TCB group. These effects are considered to be an adequate expression of maternal toxicity.
Haematological and clinical chemistry investigations showed significantly reduced haemoglobin and haematocrit values as well as a significant increase in the protein content and in the aminopyrine-N-demethylase activity in the liver at 150 mg/kg bw/day and above.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 75 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 75 mg/kg bw/day
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
Histological lesions occurred in the lenses of eyes of foetuses from the intermediate dosage group. These effects were not seen in the other two treatment groups. The ocular changes consisted of central areas of cellular disorientation and disaggregation with ballooning and granular degeneration. This finding is interpreted by the authors as possibly indicating early cataract development. However, no data on the incidence or severity of these findings are given. (Similar effects were also seen with all three groups treated with 1,3,5-TCB, when tested in the same study.) The authors draw attention to the fact that the histopathological examination of the other foetal tissues was made more difficult as a result of autolysis and insufficient conservation.
This brings into question the validity of the findings in the eye.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Table 1.Fetal data (mean ± S.E) following oral administration of 1,2,4-trichlorobenzene congeners to pregnant rats
|
1,2,4-trichlorobenzene |
|||
|
Control |
75 |
150 |
300 |
Dams at term/Inseminated |
12/14 |
11/13 |
11/13 |
12/14 |
Resorption+deadfetuses |
0.7±0.2 |
1.1±0.2 |
0.6±0.2 |
0.6±0.3 |
Littersize |
11.5±1.2 |
12.1±0.9 |
13.1±0.5 |
13.3±0.66 |
Fetal wt(g) |
5.4±0.1 |
5.3±0.1 |
5.5±0.1 |
5.1±0.1 |
Visceralobservationsa |
31 |
28 |
40 |
42 |
SkeletonObservationsa |
67 |
50 |
76 |
82b |
Sternalanomiliesc |
11/3 |
14/6 |
11/4 |
9/7 |
Wavyribsc |
1/1 |
1/1 |
0 |
0 |
Centrumfusiondelay |
0 |
0 |
3/2 |
1/1 |
14thrib |
0 |
0 |
5/5 |
2/1 |
13thrib(short) |
0 |
1/1 |
0 |
0 |
aNo. of pups examined cNo. of pups affected/No. of litters affected
bone pup hasmicrognathia; others normal *significant difference p=0.05
Histological lesions occurred in the lenses of eyes of foetuses from the intermediate dosage
group. These effects were not seen in the other two treatment groups. The ocular changes
consisted of central areas of cellular disorientation and disaggregation with ballooning and
granular degeneration. This finding is interpreted by the authors as possibly indicating early
cataract development. However, no data on the incidence or severity of these findings are given.
(Similar effects were also seen with all three groups treated with 1,3,5-TCB, when tested in the
same study.) The authors draw attention to the fact that the histopathological examination of the
other foetal tissues was made more difficult as a result of autolysis and insufficient conservation.
This brings into question the validity of the findings in the eye.
Applicant's summary and conclusion
- Executive summary:
Black (1988):
14 pregnant Sprague-Dawley rats/dose group were given 0, 75, 150 and 300 mg/kg 1,2,4-TCB dissolved in corn oil by gavage from day 6 to 15 day of gestation according with a method similar to OECD guideline 414 with restrictions (Housing and feeding conditions not reported; exposure too short; numberof animals exposed too small; weight of dams recorded only at 22nd day of gestation; food consumption, number of corpora lutea , sex of each foetus not recorded).
The doses chosen for the 1,2,4-isomer were 75, 150 and 300 mg/kg.
Maternal body weight was decreased in the high-level 1,2,4-TCB dose group, but this decrease was not significant. Other external signs of maternal toxicity were not determined.
Post-mortem examination showed slight liver changes (increased periportal cytoplasmic eosinophilia and slight anisokeryosis of the cell nuclei of the hepatocytes) in dams dosed with 150 mg/kg bw/d. In addition to these effects, a significant 5.7% increase in relative liver weight was seen in the 300 mg/kg dose group; the absolute liver weight was also significantly increased, but the weights of other organs were statistically normal. Changes in the thyroid gland were also observed in the 300 mg/kg 1,2,4-TCB group. These effects are considered to be an adequate expression of maternal toxicity.
Haematological and clinical chemistry investigations showed significantly reduced haemoglobin and haematocrit values as well as a significant increase in the protein content and in the aminopyrine-N-demethylase activity in the liver at 150 mg/kg bw/d and above.
Histological lesions occurred in the lenses of eyes of foetuses from the intermediate dosage
group. These effects were not seen in the other two treatment groups. The ocular changes consisted of central areas of cellular disorientation and disaggregation with ballooning and granular degeneration. This finding is interpreted by the authors as possibly indicating early cataract development. However, no data on the incidence or severity of these findings are given.
The authors draw attention to the fact that the histopathological examination of the other foetal tissues was made more difficult as a result of autolysis and insufficient conservation.
This brings into question the validity of the findings in the eye.
The authors conclude that none of the trichlorobenzene isomers tested in this study produced teratogenic or fetotoxic effects.
The NOAEL for the dams is 75 mg/kg bw/d in this study. For the foetuses, the NOAEL depends on the significance attributed to the eye lesions seen in the foetuses in the middle dose group.
The effects seen in the eye are not considered substance related, and therefore the NOAEL for the foetuses is 300 mg/kg bw/d. However, it cannot be entirely excluded that the effects seen in the foetal eye could be substance-related, in spite of the lack of dose dependency, and that the effect is seen in the intermediate dose only. On this basis, a NOAEL of 75mg/kg bw/d can be established for both the dams and the foetuses.
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