But-2-yne-1,4-diol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non-GLP Guideline Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

But-2-yne-1,4-diol

EC Number:

203-788-6

EC Name:

But-2-yne-1,4-diol

Cas Number:

110-65-6

Molecular formula:

C4H6O2

IUPAC Name:

but-2-yne-1,4-diol

Details on test material:

- Name of test material (as cited in study report): 1,4-Butindiol fest
- Physical state: solid
- Analytical purity: >99%

Test animals

Species:

rabbit

Strain:

other: Russian, white Chbb-SPF (THOM)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach
- Age at study initiation: no data
- Weight at study initiation: 2.2 (female) and 2.6 kg (male)
- Diet (e.g. ad libitum): K4 Alleindiät für kaninchen, ad libitum
- Water (e.g. ad libitum): tap, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 grams of the solid, unchanged (no vehicle)

Duration of treatment / exposure:

4 hours

Observation period:

14 days, with observations at 1, 24, 48 and 72 hours and 6, 8, 10, and 14 days.

Number of animals:

6; 3 males & 3 females

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: not reported
- Type of wrap if used: 6 x 6 cm polyethylene wrap secured with flexible bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize, et. al.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 1

Time point:

other: 24 to 72 hours

Score:

2.7

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animals 2, 3, 4, and 6 (individually)

Time point:

other: 24 to 72 hours

Score:

3.3

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 5

Time point:

other: 24 to 72 hours

Score:

3

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 1

Time point:

other: 24 to 72 hours

Score:

3.7

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

mean

Remarks:

animals 2 and 3

Time point:

other: 24 to 72 hours

Score:

4

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

animals 4 and 5

Time point:

other: 24 to 72 hours

Score:

3.3

Max. score:

4

Results 7

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 6

Time point:

other: 24 to 72 hours

Score:

3

Max. score:

4

Irritant / corrosive response data:

No necrosis in the first 3 minutes. All animals showed severe erythema and edema within 24 hours and signs of necrosis within 72 hours. Scab formation, tissue replacement, and scarring was also observed.

Any other information on results incl. tables

Reading	Animal	Erythema	Oedema
1 hour	1/2/3/4/5/6	0/1/1/1/1/1	4/4/4/4/3/4
24 hour	1/2/3/4/5/6	2/3/3/3/3/3	4/4/4/4/4/3
48 hour	1/2/3/4/5/6	2/3/3/3/3/3	4/4/4/3/3/3
72 hours	1/2/3/4/5/6	4/4/4/4/3/4	3/4/4/3/3/3
Average, each animal	1/2/3/4/5/6	2.7/3.3/3.3/3.3/3.0/3.3	3.7/4.0/4.0/3.3/3.3/3.0
Average, all animals	------	3.15	3.55