α-hydroxy-β,β-dimethyl-γ-butyrolactone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

α-hydroxy-β,β-dimethyl-γ-butyrolactone

EC Number:

209-963-3

EC Name:

α-hydroxy-β,β-dimethyl-γ-butyrolactone

Cas Number:

599-04-2

Molecular formula:

C6H10O3

IUPAC Name:

(3R)-3-hydroxy-4,4-dimethyloxolan-2-one

Details on test material:

- Name of test material (as cited in study report): D-Pantolacton kristallin
- Physical state: solid white crystals
- Analytical purity: >99 %

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Age at study initiation: young adults
- Weight at study initiation: males: approx. 183 g; females: approx. 173 g
- Fasting period before study: about 16 h before administration
- Housing: in stainless steel wire mesh cages, type DK-III (Becker & Co. Castrop-Rauxel, Gemany)
- Diet: Kliba Labordiaet 343 (Klingentalmuehle AG, Kaiseraugst, Switzerland); ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 20-24 °C
- Humidity: 30-70 %
- Air changes per hr: the animals were housed in fully air-conditioned rooms
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

464, 1000 and 2000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

Signs and symptoms:
- Time of day of administration: in the morning
- Observation period: 14 days
- Signs and symptoms: recording of signs and symptoms several times on the day of administration, at least once each workday. Check for moribund and dead animals twice each workday and once on holidays.

Pathology:
Withdrawal of food about 16 h before sacrifice with CO2; then necropsy with gross-pathological examination. Necropsy of all animals that died as early as possible.

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 2 000 mg/kg bw

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

In the 2000 mg/kg bw dose group, 3/5 female animals died within the first hour after administration of the test material. All animals of the other dose groups (males and females) survived until the end of the study period.

Clinical signs:

other: No clinical signs of toxicity were observed in all animals of both sexes dosed with 464 or 1000 mg/kg bw of the test material. The following clinical signs of toxicity were observed in the male animals of the 2000 mg/kg bw group: poor general state (H0-D1

Gross pathology:

- Animals that died during the study (3 females at 2000 mg/kg bw): general congestion.
- Sacrificed animals (males and females): no pathological findings noted.

Any other information on results incl. tables

Table 1: Mean body weights of the animals during the study period:

sex	time point	mean body weight (g) for dose group 464 mg/kg bw	mean body weight (g) for dose group 1000 mg/kg bw	mean body weight (g) for dose group 2000 mg/kg bw
male	before application	180	188	180
	after 7 days	254	259
	after 8 days			260
	after 10 days			274
	after 13 days	289	293
female	before application	178	169	171
	after 7 days	209	203
	after 8 days			204
	after 10 days			208
	after 13 days	220	216