Corn, steep liquor

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study without detailed documentation.

Data source

Reference

Reference Type:

publication

Title:

Concurrent ingestion of lactate and Aluminium can result in developmental toxicity in mice

Author:

Colomina MT, Gómez M, Domingo JL, Llobet JM & Corbella J

Year:

1992

Bibliographic source:

Res.Commun. Chem. Pathol. Pharmacol. 77: 95-106 (1992)

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Deviations:

yes

Remarks:

Mice were exposed by gavage daily on gestation days 6-15. Cesarean sections were performed on gestation day 18.

GLP compliance:

not specified

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lactic acid

EC Number:

200-018-0

EC Name:

Lactic acid

Cas Number:

50-21-5

Molecular formula:

C3H6O3

IUPAC Name:

2-hydroxypropanoic acid

Details on test material:

- Name of test material (as cited in study report): Lactic acid

Test animals

Species:

mouse

Strain:

CD-1

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna Ibérica, Barcelona, Spain
- Age at study initiation: Not reported
- Weight at study initiation: 28 to 32 g
- Fasting period before study: Not reported
- Housing: Plug-positive females were housed in solid-bottom polycarbonated cages with stainless steel wire lids; no futher details provided.
- Diet (e.g. ad libitum): Feed (Panlab rodent chow, Barcelona), ad libitum
- Water (e.g. ad libitum): Water (source not reported), ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 40 to 60
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on exposure:

PREPARATION OF DOSING SOLUTIONS:Not reported

Analytical verification of doses or concentrations:

not specified

Details on analytical verification of doses or concentrations:

Not reported

Details on mating procedure:

- Impregnation procedure: co-housed
- If cohoused:
- M/F ratio per cage: 1/2
- Length of cohabitation: overnight
- Proof of pregnancy: vaginal plug designated as day 0 of pregnancy

Duration of treatment / exposure:

Gestational days 6-15

Frequency of treatment:

Daily

Duration of test:

10 days

Doses / concentrations

Remarks:

Doses / Concentrations:
570 mg/kg bw/day
Basis:
actual ingested

No. of animals per sex per dose:

12 dams

Control animals:

other: a control group received distilled water during the same period (13 dams).

Details on study design:

Not reported

Examinations

Maternal examinations:

BODY WEIGHT: Yes
- Time schedule for examinations: Daily for pretreatment, treatment, and post-treatment periods


FOOD CONSUMPTION AND COMPOUND INTAKE: Yes



POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 18
- Organs examined: Uteri

Ovaries and uterine content:

The ovaries and uterine content was examined after termination: Yes
Examinations included: Gravid uterus weight, number of total implantations, number of live and dead fetuses, and number of resorptions.

Fetal examinations:

- External examinations: Yes: all per litter
- All live fetuses were removed from the uterus, weighed, sexed, and examined for external abnormalities. After the external examination was completed, approximately one-third of the fetuses from each group were fixed in Bouin’s solution and examined for visceral anomalies. The remaining fetuses were fixed with Alizarin red solution and examined for skeletal abnormalities.

Statistics:

Test groups were compared to the control group at a level of significance of p<0.05. Results of the continous variables (e.g., maternal body weight, food consumption, fetal weight, etc) were analyzed using a one-way analysis of variance (ANOVA) with significant F values further analyzed using Duncan's multiple range test. Nonparametic data were statistically evaluated using the Kruskal-Wallis test when appropriate. Incidence data were compared using chi square contingency tables.

Indices:

Not reported

Historical control data:

Not reported

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:

Maternal toxic effects:yes

Details on maternal toxic effects:
-No effects on maternal body weight were observed. Food consumption was significantly reduced during the treatment (Gestation days 6 to 9 and 6 to 12) and post-treatment periods (Gestation days 15 to 18). Gravid uterine weight, absolute liver weight, and absolute and relative kidney weight were not affected by the treatment. A significant decrease in relative liver weight in the lactic acid group compared to the control group was noted.

Effect levels (maternal animals)

Dose descriptor:

NOAEL

Effect level:

570 mg/kg bw/day

Basis for effect level:

other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:yes

Details on embryotoxic / teratogenic effects:
Evaluation of gestational parameters for the mice did not show significant treatment-related effects on the number of total implantations per litter, viable or non-viable implants per litter, percentage postimplantation loss, or sex ratio. Incidence of delayed ossification of parietals was noted. However, anatomical malformations or variations were not noted to occur with a higher incidence than controls in lactic acid group.

Effect levels (fetuses)

1

Dose descriptor:

NOAEL

Effect level:

570 mg/kg bw/day

Basis for effect level:

other: teratogenicity

2

Dose descriptor:

NOAEL

Effect level:

570 mg/kg bw/day

Basis for effect level:

other: embryotoxicity

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Any other information on results incl. tables

Lactic acid was neither maternotoxic, embryofetotoxic, nor teratogenic when given orally to mice at 570 mg/kg bw/day on gestation days 6-15.