Study type Route Doses NOAEL Reference (mg/kg (mg/kg bw/d) bw/d) & endpoint 2-methyoxyethanol (2-ME) untreated females Chimera assay Oudiz et Mice, Swiss ICR al., 1993 (11-19/group) Gavage 0, 750, 1500 mg/kg bw/d NE: 750: infertility 5 days then mated to at week 4 spermatocytes Repeat dose within 24h; Gavage 0, 50, 100, 250, Foster et Rats, Sprague – 250: rel 500 mg/kg bw/d ↓ al., 1983 Dawley testes wt male 7 days; rel ↓ 11 days 50 100: liver wt degeneration of Gavage 0, 2.07, 4.14 mmol/kg NE: 158 (2.07 Development mmol/kg): Ritter et Rats, Wistar al., 1985 resorptions, ↑ (6-8/group) gross & ↑ GD 12 skeletal mals i.p. 0, 2.07, 4.14 mmol/kg NE: 158 (2.07 Development mmol/kg): Ritter et Rats, Wistar al., 1985 resorptions, ↑ (6-8/group) & GD 12 ↑ skeletal mals 36 Development Gavage 0, 12, 24, 36 mg/kg bw/d NE 12: Macaca ↑ intrauterine (4/group) Scott et al., death, 100% at GD 20-45 1989* Methoxyacetic acid (MAA) Gavage 0, 2.07, 4.14 mmol/kg NE: 187 (2.07 Development mmol/kg): Ritter et Rats, Wistar resorptions, ↑ al., 1985 & GD 12 ↑ skeletal mals 4 days testes wt Repeat dose Rats, Sprague – Dawley Foster et Gavage 0, 592 mg/kg bw/d NE 592: rel ↓ male al., 1983 Wt: weight; abn: abnormal; sem: seminifereous; degeneration; mals: malformations; rel: relative; d: day; NE: not established
Study type Route Doses NOAEL (mg/kg bw/d) 2-methyoxyethanol (2-ME) (mg/kg bw/d) & endpoint Reference Chimera assay Mice, Swiss ICR (11-19/group) 5 days then mated to untreated females Gavage 0, 750, 1500 mg/kg bw/d NE: 750: infertility at week 4 Oudiz et al., 1993 Repeat dose Rats, Sprague – Dawley male 11 days Gavage 0, 50, 100, 250, 500 mg/kg bw/d 50 100: degeneration of spermatocytes within 24h; 250: ↓ rel testes wt 7 days; ↓ rel liver wt Foster et al., 1983 Development Rats, Wistar (6-8/group) GD 12 Gavage 0, 2.07, 4.14 mmol/kg NE: 158 (2.07 mmol/kg): ↑ resorptions, ↑ gross & skeletal mals Ritter et al., 1985 Development Rats, Wistar (6-8/group) GD 12 i.p. 0, 2.07, 4.14 mmol/kg NE: 158 (2.07 mmol/kg): ↑ resorptions, ↑ & skeletal mals Ritter et al., 1985 Development Macaca (4/group) GD 20-45 Gavage 0, 12, 24, 36 mg/kg bw/d NE 12: ↑ intrauterine death, 100% at 36 Scott et al., 1989* Methoxyacetic acid (MAA) Development Rats, Wistar GD 12 Gavage 0, 2.07, 4.14 mmol/kg NE: 187 (2.07 mmol/kg): ↑ resorptions, ↑ & skeletal mals Ritter et al., 1985 Repeat dose Rats, Sprague – Dawley male 4 days Gavage 0, 592 mg/kg bw/d NE 592: ↓ rel testes wt Foster et al., 1983 Wt: weight; abn: abnormal; sem: seminifereous; degeneration; mals: malformations; rel: relative; d: day; NE: not established
DMEP-hazard-assessment.docx