Registration Dossier
Registration Dossier
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EC number: 208-792-1 | CAS number: 541-73-1
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral
- Remarks:
- other: 10 day study
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicity studies of 1,3-dichlorobenzene in Sprague-Dawley rats
- Author:
- McCauley PT, Robinson M, Daniel FB, and Olson GR.
- Year:
- 1 995
- Bibliographic source:
- Drug & Chem. Toxicol. 18, 201-221
Materials and methods
- Principles of method if other than guideline:
- Male and female rats were does daily by gavage for 10 consecutive days. All rats were observed daily for physiological and behavioral responses and for mortality, hematology, clinical chemistry, and histopathological changes.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 1,3-dichlorobenzene
- EC Number:
- 208-792-1
- EC Name:
- 1,3-dichlorobenzene
- Cas Number:
- 541-73-1
- Molecular formula:
- C6H4Cl2
- IUPAC Name:
- 1,3-dichlorobenzene
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 1,3-dichlorobenzene
- Analytical purity: 99.99%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Portage, MI, USA
- Age of the animals when received in the testing laboratory: 70 days
- Weight at study initiation: 300-325 g (males); 225-250 g (females)
- Housing: Animals were used 2 per cage by sex in polycarbonate hardwood chip bedding (Absorb-Dri, Maywood, NY, USA)
- Diet (e.g. ad libitum): Purina Certufid Rodent Chow 5002 (Ralston-Purina Co., St. Louis, MO, USA) ad libitum
- Water (e.g. ad libitum): ad libitum
- Quarantine period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Animals were held in a temperature controlled room
- Humidity (%): Animals were held in a humidity controlled room
- Photoperiod (hrs dark / hrs light): 12 hrs dark: 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 10 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 37, 147, 368 or 735 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 10 male and 10 female animals/dose
- Control animals:
- yes
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 37 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LOAEL
- Effect level:
- 147 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: increased relative liver and kidney weights occurred and in male rats and a vacuolization in cells of the pars distalis in the pituitary glands were observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
37 mg/kg body weight: NOAEL
147 mg/kg body weight and above:
liver: ♂: relative weights increased, ♂, ♀: sporadic cell necrosis
368 mg/kg body weight:
♂: relative kidney weights increased;
368 and 735 mg/kg body weight:
♀: serum cholesterol increased; liver: ♀: relative weights increased
735 mg/kg body weight:
♂, ♀: body weights decreased (♂ 20%, ♀ 13%); liver: hepatocellular degeneration
(♂ 9/10, ♀ 9/9); thymus atrophy (♂ 2/10, ♀ 2/9)
Applicant's summary and conclusion
- Executive summary:
Male and female Sprague-Dawley rats received 1 ,3-dichlorobenzene daily by corn oil gavage for 10 consecutive days. The 10-day study doses were 0, 37, 147, 368 and 735 mg/kg. ln the 10-day study, there was a signiflcant depression of body weight in both sexes at 735 mg/kg. Liver weights were significantly increased in both sexes at 368 and 735 mg/kg. Serum cholesterol levels were significantly elevated in both sexes at 368 and 735 mg/kg.
Histopathological evaluation revealed centrolobular hepatocellular degeneration at 368 mg/kg in males and 735 mg/kg in females.
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