Bis(C12-C13)alkyl-2-hydroxybutandioate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): COSMACOL EMI
- Substance type: pure active substance
- Physical state: liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Morini - S. Polo d'Enza (RE), Italy
- Age at study initiation: no data
- Weight at study initiation: 150 - 200 g
- Fasting period before study: not mentioned
- Housing: in groups of 5 per sex per cage (polycarbonate, dimensions 425x266x180 mm)
- Diet (e.g. ad libitum): standard pellet complete diet ad libitum
- Water (e.g. ad libitum): filtered tap water ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 55 +/- 15
- Air changes (per hr): 25
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 02-JUN-1992 To: 16-JUN-1992

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

vegetable oil

Remarks:

(sesame seed oil)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 500 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): no data
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality: daily in the working week (5 out of 7 days)
Clinical symptoms (including evaluation of organic bodys functions, tegumentary apparatus, mucosae conditions, somatomotor activity and sensorium conditions): daily in the working week (5 out of 7 days)
Body weight: before the experiment, at day 7 and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

Signs of toxicity related to dose levels: After 6 hours from administration and during further 48 hours 3 male rats showed an intense fur-erection. One male rat showed ante- and post mortem a mycosis in right foreleg.

Body weight:

Body weight gain was normal.

Gross pathology:

Effects on organs: At the necropsy examination a slightly reddened gastric mucosa was observed in all animals.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 in rats of Bis(C12-C13)alkyl-2-hydroxybutandioate was greater than 5000 mg/kg bw.

Executive summary:

An acute oral toxicity test was carried out on a group of 10 rats (5 male and 5 female) using test material Bis(C12-C13)alkyl-2-hydroxybutandioate according to OECD guideline 401. The test material was administered at a dose of 5000 mg/kg by using a stomach tube. There were no cases of mortality during the study . 3 of 10 rats showed piloerection from day 1 - 3. The body weight gain was normal during the study. At the necropsy all animals showed slightly reddened gastric mucosa. The LD50 was greater than 5000 mg/kg bw and Bis(C12-C13)alkyl-2-hydroxybutandioate was found to be non-toxic under experimental conditions.