Submitter name: Chlorobenzene Producers Association

Submission date: 2/13/1998

Was the submission provided under the Compliance Audit Program (CAP)?

• No

Chemical testing

Correspondence/letter of notification:

• Summary of correspondence

Human health effects

Follow-up submission

No

REPEATED DOSE TOXICITY:

• Study Type
  • Other: Two generation reproduction/development toxicity test

• Protocol/guideline
  • Other: Not reported

• Year Study Performed 1994

• Was the Study
  • Measured

• Duration of Study 2 generations

• Species
  • Rat

• Strain Sprague-Dawley

• Sex of Organisms
  • Female
  • Male

• Number of Organisms per Group 28/sex

• Test Substance Purity Not reported

• Dose/Concentrations 30, 90, and 270 mg/kg/day

• Dose Frequency Daily

• Exposure period Not reported

• Route
  • Oral

• Results based on critical effect Increased kidney and liver weight were observed in conjunction with nephrotoxicity in parental males at 270 mg/kg/day. In the F1 generation, liver weights were increased at 90 mg/kg/day. Based on these results, the submission sponsor finds that the NOAEL for the F0 and F1 parental animals was 30 mg/kg/day which the authors estimate corresponds to 450 mg/m3 inhalation.

• Study Results NOAEL (parental) = 30 mg/kg/day

REPRODUCTIVE TOXICITY:

• Study Type
  • Other: Two generation reproduction/development toxicity test

• Protocol/guideline
  • Other: Not reported

• Year Study Performed 1994

• Was the Study
  • Measured

• Duration of Study 2 generations

• Species
  • Rat

• Strain Sprague-Dawley

• Sex of Organisms
  • Female
  • Male

• Number of Organisms per Group 28/sex

• Test Substance Purity Not reported

• Dose/Concentrations 30, 90, and 270 mg/kg/day

• Dose Frequency Daily

• Exposure period Not reported

• Route
  • Oral

• Results based on critical effect There were no adverse effects observed on fertility parameters. Based on the results, the submission sponsor finds that the NOAEL for fertility is 270 mg/kg/day.

• Study Results NOAEL = 270 mg/kg/day

DEVELOPMENTAL TOXICITY:

• Study Type
  • Other: Two generation reproduction/development toxicity test

• Protocol/guideline
  • Other: Not reported

• Year Study Performed 1994

• Was the Study
  • Measured

• Duration of Study 2 generations

• Species
  • Rat

• Strain Sprague-Dawley

• Sex of Organisms
  • Female
  • Male

• Number of Organisms per Group 28/sex

• Test Substance Purity Not reported

• Dose/Concentrations 30, 90, and 270 mg/kg/day

• Dose Frequency Daily

• Exposure period Not reported

• Route
  • Oral

• Results based on critical effect Decreased numbers of living pups at birth, increased pup mortality during lactation period, and reduced pup bodyweights were observed at 90 and 270 mg/kg/day. In addition, there were adverse effects on growth and in the kidneys of both generations. Based on the results, the submission sponsor finds that the NOAEL for developmental effects is 30 mg/kg/day, which corresponds to an inhaled dose of 450 mg/m3.

• Study Results NOAEL = 30 mg/kg/day

Reference Cited: Wien. Klin. Wochenschr.

Publication authors and institution: N. Bornatowicz et al.

Publication date: 1994

Publication volume and page: 106: 345-353