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DL-LACTONE CAS N°:79-50-5 - page 82 / 113

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OECD SIDS 5. TOXICITY

DL-LACTONE

ID: 79-50-5 DATE: 18.01.2006

Test substance:

effects. In the 10% test substance/FCA treatment croup, 5/10 animals showed grade 2 erythema, 1/10 showed grade 1 erythema and the remaining 4/10 showed necroses with diameters of 2, 3, 3 and 4 mm; in the 5 FCA-only controls, 3/5 showed grade 1 erythema and 2/5 showed grade 2 erythema. The skin effects caused by the epidermal exposure during the induction phase are summarised as follows: 9/10 test animals showed no effects at all while the remaining 1/10 showed grade 1 erythema (this animal had shown grade 1 respectively grade 2 erythema on intradermal respectively epidermal induction), while all 5 control animal showed no effect. Main Study, Challenge No skin reactions were evident after the challenge exposure in both experimental and control animals. No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as the controls over the study period. dl-Lactone from DSM (until 2003 Roche) Dalry, sample no.

Conclusion:

06085776, purity 99.6%, dated 24-Sep-2004. In a guinea pig maximisation test with intradermal subsequent epicutaneous induction and epicutaneous

and challenge,

there was no evidence that dl-Lactone had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase.

This corresponds to a sensitisation rate

gives strong evidence for dl-Lactone

not

of 0%, which in being a dermal

turn

Reliability: Flag: 18-JAN-2006

sensitiser. (1) valid without Critical study for

restriction SIDS endpoint

(54)

5.4 Repeated Dose Toxicity

Type: Species: Strain: Route of administration: Exposure period: Frequency of treatment: Post exposure period: Doses:

Control Group:

Sub-chronic rat other: Wistar Crl: gavage

Sex: male/female (WI) BR (outbred, SPF quality)

males: 28 days; females: 28-56 days, mean value 43 days once daily none

  • 0

    (controls, vehicle only = milli-U water), 40, 200 and

1000 mg/kg bw/d yes, concurrent vehicle

NOAEL:

= 200 mg/kg bw

LOAEL:

= 1000 mg/kg bw

Method:

Year: GLP: Test substance:

other: OECD Guideline 422, "Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test", 22-Mar-1996 2003 yes as prescribed by 1.1 - 1.4

Method:

Test substance formulation Vehicle Water (Milli-Q) of 37ºC adjusted to pH 4. Acetic acid

was added to milli-Q water to obtain pH 4. Rationale for vehicle: Based on trial formulations performed at NOTOX and on information provided by the sponsor. During NOTOX Project

82

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