Submitter name: DuPont

Submission date: 1/6/2010

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

• No

Chemical testing

Human health effects

Final report submission

Yes:

• If yes, provide link to supplement records or template display

REPRODUCTIVE TOXICITY:

• Study Type
  • Prenatal development developmental toxicity study

• Protocol/guideline
  • OPPTS 870.3700 (OECD 414) - Prenatal Developmental Toxicity Study

• Good Lab Practices
  • Yes

• Year Study Performed

• Was the Study
  • Measured

• Duration of Study 44 days

• Species
  • Rat

• Strain Crl:CD(SD)

• Sex of Organisms
  • Female

• Number of Organisms per Group 22

• Test Substance Purity Not reported (for formaldehyde)

• Dose/Concentrations 0, 100, 300, and 900 mg/kg/day (mixture composition: 71.3% glycolic acid (CAS 79-14-1), 1.0% methoxyacetic acid (CAS 625-45-6), 1.0% diglycolic acid (CAS 110-99-6), 0.3% formic acid (CAS 64-18-6), and 0.04 ppm formaldehyde (CAS 50-00-0))

• Dose Frequency Once daily (gavage)

• Exposure period Gestation days 6-20

• Route
  • Oral

• Results based on critical effect In a prenatal toxicity study the test material containing 0.04 ppm formaldehyde was administered to pregnant rats daily by gavage. The number of corpora lutea, implantation sites, resorptions were comparable across all dose groups and live fetuses and sex ratio were not affected.

• Study Results No reproductive effects were reported.

DEVELOPMENTAL TOXICITY:

• Study Type
  • Other: Prenatal developmental toxicity study

• Protocol/guideline
  • Other: OECD 414

• Good Lab Practices
  • Yes

• Year Study Performed 2008-2009

• Was the Study
  • Measured

• Duration of Study 44 days

• Species
  • Rat

• Strain Crl:CD(SD)

• Sex of Organisms
  • Female

• Number of Organisms per Group 22

• Test Substance Purity Not reported

• Dose/Concentrations 0, 100, 300, and 900 mg/kg/day (mixture composition: 71.3% glycolic acid (CAS 79-14-1), 1.0% methoxyacetic acid (CAS 625-45-6), 1.0% diglycolic acid (CAS 110-99-6), 0.3% formic acid (CAS 64-18-6), and 0.04 ppm formaldehyde (CAS 50-00-0))

• Dose Frequency Once daily (gavage)

• Exposure period Gestation days 6-20

• Route
  • Oral

• Results based on critical effect In a prenatal toxicity study the test material containing 0.04 ppm formaldehyde was administered to pregnant rats daily by gavage. Transient reduction in maternal body weights (GD 6-8) were observed but were not statistically significant. No other maternal toxicity was observed at any dose. At 900 mg/kg/day, developmental effects included two litters with malformed fetuses (absent and fused ribs, hemivertebrae, sternoschisis, gastroschisis, macropthalmia, and absent stomach and intestines), increased incidence in fetal variations (bipartite ossification of the thoracic and/or lumbar centrum, misaligned sternebrae, and supernumerary ribs), and reduced mean fetal weights (10% lower than the control group). No evidence of developmental toxicity was observed at 300 mg/kg/day and lower. Based on these results, the submission sponsor finds that the developmental NOAEL is 300 mg/kg/day, and LOAEL is 900 mg/kg/day; NOAEL for maternal toxicity was 900 mg/kg/day, highest tested dose.

• Study Results Developmental NOAEL = 300 mg/kg/day, and LOAEL = 900 mg/kg/day based on malformations and reduced fetal weight; maternal NOAEL = 900 mg/kg/day, highest tested dose