Hex-3-yne-2,5-diol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 13, 2002 until July 08, 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Remarks:

testing lab.

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hex-3-yne-2,5-diol

EC Number:

221-209-5

EC Name:

Hex-3-yne-2,5-diol

Cas Number:

3031-66-1

Molecular formula:

C6H10O2

IUPAC Name:

hex-3-yne-2,5-diol

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Young adult animals with a comparable weight were used. The acclimatization period was at least one week.
The animals were housed in fully air-conditioned rooms with central air-conditioning in a range of 20 - 24°C for temperature and of 30 - 70% for relative humidity. The day/night rhythm was 12 hours dark and 12 hours light. The animals were singly housed in stainless steel wire mesh cages.
Animal identification was done by cage cards and tail marking. A standardized animal diet and drinking water were available ad libitum.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Single application to the clipped epidermis (dorsal and dorsolateral parts of the trunk); covering of the application site with a semi-occlusive dressing (the bandage consists of 4 layers absorbent gauze, Ph. Eur. Lohmann GmbH & Co. KG and Fixomull stretch (adhesive fleece), Beiersdorf AG) for 24 hours, afterwards removal of the dressing. Rinsing of the application site with warm water.
Clipping of the fur about 24 hours before the beginning of the study.
Application area: about 40 cm2

Duration of exposure:

single application

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Body weight determination: Individual body weights shortly before application (day 0), weekly thereafter and at the end of the study .
Signs and symptoms: Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
Scoring of skin findings: Individual readings 30 - 60 minutes after removal of the semiocclusive dressing (day 1), as a rule weekly thereafter and at the end of the study (last day of the observation period).
Assessment of skin findings: According to Draize, J .H . (1959): Appraisal of the safety of chemicals in foods, drugs and cosmetics. The association of food and drug officials of the United States Austin, Texas.
Mortality: A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
Pathology: Necropsy with gross-pathology examination on the last day of the observation period after killing with C02.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: Male animals: No signs of systemic toxicity were observed during clinical examination. Skin effects at the application site comprised well-defined erythema to moderate to severe erythema, erythema extending beyond the area of exposure, slight edema to mod

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study, except in the skin of the application site, where few skin lesions with incrusted surface were observed (three male and all female animals).