Tetrahydrothiopyran-3-carboxaldehyde

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented study report comparable to guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

the observation period was only 8 days and not 14 days as recommended in the guideline. This deviation is critical since one animal still showed signs of irritation at study termination

GLP compliance:

no

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 / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach (main), Germany
- Age at study initiation: no data
- Weight at study initiation: mean weight males: 3.06 kg , Female: 2.78 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

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:

not applicable, the test substance was not washed out as recommended in the guideline

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

3 animals, 2 males, 1 female

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none



SCORING SYSTEM: the OECD Draize scoring system was used
Cornea: opacity (op): Degree of density (area most dense taken for reading)

0 = No ulceration or opacity.
1 = Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible.
2 = Easily discernible translucent area, details of iris slightly obscured.
3 = Nacreous area, no details of iris visible, size of pupil barely discernible.
4 = Opaque cornea, iris not discernible through the opacity.

Area of cornea involved (ar):
1 ≥ 0 ; ≤ ¼
2 ≥ ¼; < ½
3 ≥ ½; < ¾
4 ≥ ¾

Conjunctivae
Redness (red): (Refers to palpebral and bulbar conjunctivae, cornea and iris)

0 = Blood vessels normal
1 = some blood vessels definitely hyperemic (injected)
2 = Diffuse, crimson color, individual vessels not easily discernible.
3 = Diffuse beefy red.

Chemosis (sw):

0 = No swelling.
1 = Any swelling above normal (includes nictitating membranes).
2 = Obvious swelling with partial eversion of lids
3 = Swelling with lids about half closed
4 = Swelling with lids more than half closed eye

Iris:
0 = Normal
1 = Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive).
2 = No reaction to light, hemorrhage, gross destruction (any or all of these).

Discharge (di):
0 = No discharge
1 = Any amount different from normal (does not include small amounts ob served in inner canthus of normal animals).
2 = Discharge with moistening of lids.
3 = Discharge with moistening of the lids and hairs, and considerable area around the eye

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

mean

Time point:

other: 24, 48, 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

mean

Time point:

other: 24, 48, 72 hours

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

mean

Time point:

other: 24, 48, 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.7

Max. score:

2

Reversibility:

fully reversible

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.3

Max. score:

2

Reversibility:

fully reversible

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

mean

Time point:

other: 24, 48, 72 hours

Score:

1

Max. score:

2

Reversibility:

fully reversible

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

mean

Time point:

other: 24, 48, 72 hours

Score:

2

Max. score:

3

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

mean

Time point:

other: 24, 48, 72 hours

Score:

2

Max. score:

3

Reversibility:

fully reversible

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

mean

Time point:

other: 24, 48, 72 hours

Score:

2

Max. score:

3

Reversibility:

fully reversible

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean

Time point:

other: 24, 48, 72 hours

Score:

1.3

Max. score:

3

Reversibility:

fully reversible

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean

Time point:

other: 24, 48, 72 hours

Score:

1.3

Max. score:

3

Reversibility:

fully reversible

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

mean

Time point:

other: 24, 48, 72 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible

Any other information on results incl. tables

Readings	Animal	Cornea		Iris	Conjunctiva			Additional findings
		op	ar		red	ch	di
1 h	1	0	-	0	2	2	-
	2	0	-	0	2	3	-	PC
	3	0	-	0	2	2	-
24 h	1	1	-	1	2	2	-
	2	1	-	0	2	2	-
	3	1	-	1	2	2	-
48 h	1	1	-	1	2	1	-	PC/RE
	2	1	-	0	2	1	-	PC/S
	3	1	-	1	2	1	-
72 h	1	1	-	0	2	1	-	RE
	2	1	-	1	2	1	-	PC
	3	1	-	1	2	0	-
8 d	1	0	-	0	0	0	-	RE
	2	1	-	0	0	0	-
	3	0	-	0	0	0	-
Mean 24 -72 h	1	1	-	0.7	2	1.3	-
	2	1	-	0.3	2	1.3	-
	3	1	-	1.0	2	1	-
Mean 24-72 h	1-3	1		0.7	2	1.2

Calculation of the mean according to 83/467/EEC criteria of July 29^th, 1983.

 

 

Symbols:

(-): not reported

LC: Loss of corneal tissue

LH: Loss of hair at margins of eyelids

MV: Marginal vascularization of the cornea

PC: Pupil contracted

RE: small retractions in the eyelids

S: suppuration

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information