Registration Dossier
Registration Dossier
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EC number: 201-757-1 | CAS number: 87-61-6
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 1,2,5-trichlorobenzenes in rats.
- Author:
- Black WD et al
- Year:
- 1 988
- Bibliographic source:
- Bull. Environ. contam. Toxicol 41, 719-726
- Reference Type:
- publication
- Title:
- Evaluation of risks to health from environmental exposure in Canada
- Author:
- Giddings M
- Year:
- 1 994
- Bibliographic source:
- Carcino.Ecotox. Revs. C12, 517-525
- Reference Type:
- publication
- Title:
- A teratological evaluation following oral administration of trichloro- and dichlorobenzene to the rat.
- Author:
- Ruddick VK 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; number of 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:
- 1,2,3-trichlorobenzene
- EC Number:
- 201-757-1
- EC Name:
- 1,2,3-trichlorobenzene
- Cas Number:
- 87-61-6
- Molecular formula:
- C6H3Cl3
- IUPAC Name:
- 1,2,3-trichlorobenzene
- Details on test material:
- - Name of test material (as cited in study report): 1,2,3-trichlorobenzene
- Analytical purity: 99.5%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration of treatment / exposure:
- day 6 - day 15 of gestation
- Frequency of treatment:
- once daily
- No. of animals per sex per dose:
- Each groups consisted of approximately 13-14 dams
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Sex: female
Duration of test: until day 22
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 150 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 600 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
--None of the animals displayed any signs of toxicity,
--Body weight development was not affected.
--Mortality
300 mg-group: 1 dam died
control group: 1 dam died
--Fetal data
no difference to the concurrent control in
number of dams at term, nimber of dams inseminated, resorptions, dead fetuses, fetal weights, litter size
no viseral or skeletal abnormalities
- Skeletal deviations
(number of pups affected/number of litters affected 150 mg-gr., 300 mg-gr., 600 mg-gr versus control):
Sternal anomalies: 1/1, 1/1, 13/3 versus 1/1
wavy ribs: 0, 1/1, 1/1 versus 1/1
14th rib: 1/1, 0, 0 versus 0
13th rib(short): 1/1, 0, 0 versus 0
----Maternal data (significant changes):
--increase in relative liver weight:
600 mg-gr: 5.8 % versus 5.1% of control
--increase in ADPM activity:
600 mg-gr: 27.3 nanomoles formaldehyde/hr/mg protein versus
22.8 nanomoles formaledhyde/hr/mg protein of control
--decrease in hemoglobin concentration:
500mg-gr, 300 mg-gr: 11.3g/dl, 11.3g/dl versus 12.0g/dl of control
--decrease in hematocrit levels:
600 mg-gr: 31.1% versus 33.3% of controls
--histopathology.
-thyroid, 300 mg-gr and 600 mg-gr: reduction in follicle size accompanied by agular collapse; 600 mg-gr:increased epithelial height accompanied by cytoplasmatic vacuolation
-liver, 300 mg-gr, 600 mg-gr: mild increased periportal cytoplasmic eosinophilia and mild anisokaryosis of hepatocellular nuclei
-spleen
mild increased hematopoiesis in some females (no further information)
--TRCB residues:
only found in traces in the perirenal fat of the 300 mg-gr. and 600 mg-gr consistting of 0.02 and 0.4 ppm, respectively
Applicant's summary and conclusion
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