Tetrahydrothiopyran-3-carboxaldehyde

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:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): 3.4.5.6-Tetrahydro-2H-Thiopyran-3-Carboxyaldehyd
- Substance No.: 84/0242
- Analytical purity: 98 %
- no further data

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach (Main), Germany
- Age at study initiation: no data
- Weight at study initiation: mean weight males: 2.16 kg, Female: 2.25 kg
- Housing: individual
- Diet: Kliba Laboratory diet 341, 4 mm, Klingenthalmuehle, Kaiseraugst, Switzerland; about 130 g/day
- Water: Tap water 250 ml/day
- Acclimation period: at least 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3 animals (2 males, 1 female)

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: semiocclusive dressing


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol concentrated and Lutrol diluted to 50 % with water
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to OECD Draize scores
Erythema formation:
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet-redness) to slight, eschar formation (injuries in depth)

Edema formation:
0: No edema
1: Very slight edema (barely perceptible)
2: Slight edema (edges of area well defined by definite rising)
3: Moderate edema (raised approx. 1 mm)
4: Severe edema (raised more than 1 mm and extending beyond the area of exposure)

Pathology
After sacrifice the animals are examined by gross pathology, if there are signs of necroses. These are confirmed by gross-pathological examination after incision of the skin. If there are differences between clinical and pathological findings, only the latter are included in the final report.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean

Time point:

other: 24, 48, 72 hours

Score:

1.3

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Any other information on results incl. tables

Readings	Animal	Exposure period: 4 h
		Erythema	Edema	Additional findings
4 h	1	2	1
	2	1	0
	3	2	1
24 h	1	2	1
	2	1	0
	3	1	0
48 h	1	1	0
	2	0	0
	3	0	0
72 h	1	1	0
	2	0	0
	3	0	0
8 d	1	0	0
	2	0	0
	3	0	0
Mean 24, 48, 72 h	1	1.3	0.3
	2	0.3	0
	3	0.3	0
Mean 24, 48, 72 h	1-3	0.7	0.1

Since all signs of irritation returned to normal on day 8 of the observation period, the study was terminated earlier as indicated in the guidance document.