3-(methylthio)propionaldehyde

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985-07-22 to 1985-08-26

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1985

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 09 Oct 2017

Deviations:

yes

Remarks:

no anaesthetic used

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: FIFRA Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals; Office of Pesticide Programs, U.S. Environmental Protection Agency, Office of Pesticides and Toxic Substances, November 1982; Section 81-4, Primary Eye Ir

Version / remarks:

adopted Nov 1982

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: TSCA: Health Effects Test Guidelines, Office of Toxic Substances, Office of Pesticides and Toxic Substances, United States Environmental Protection Agency, August 1982 Acute Exposure, Primary Eye Irritation

Version / remarks:

adopted Aug 1982

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-(methylthio)propionaldehyde

EC Number:

221-882-5

EC Name:

3-(methylthio)propionaldehyde

Cas Number:

3268-49-3

Molecular formula:

C4H8OS

IUPAC Name:

3-(methylthio)propionaldehyde

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Source: Hazleton Dutchland, Inc., Denver, Pennsylvania, USA
- Age at study initiation: at least 8 weeks
- Acclimatisation period: 14 days
- Housing: Individually housed
- Diet: Lab Rabbit Chow HF (Purina #5326), ad libitum
- Water: automatic watering system (municipal water), ad libitum

Environmental conditions:
- Temperature: 60 - 70°F (16-21 °C)
- Humidity: 30-70%
- Light cycle: 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

24 h

Observation period (in vivo):

21 days
Reading time points: 1, 24, 48 and 72 h, and 7, 14 and 21 days

Number of animals or in vitro replicates:

1

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Approximately 24 h after test item instillation the treated eye was rinsed to remove any residual test material.
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: Fluorescein dye was used to confirm presence or absence of corneal ulceration in the treated eye starting with the 24 hour observation and at each subsequent observation until there was no stain retention for two observations.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.67

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

not reversible

Irritant / corrosive response data:

Moderate to severe conjunctival redness (score 1-3) was observed within the first 72 hours post test item instillation and remained well-defined (score 2) on study Day 7. The effect was fully reversible until study Day 14. In addition, chemosis (score 1-2) was observed until study Day 14, but was reversible by study Day 21. Iritis (score 1) was observed within the first 72 hours after test item instillation, but the animal recovered from it thereafter. Extensive corneal opacification was seen one hour after dosing and persisted through Day 21. Pannus (neovascularisation of the cornea) occurred from Day 7 through 21, and a red mass (probability vascular in origin) on the cornea was seen on Day 14. Protrusion of the cornea considered indicative of intraocular pressure, was also seen on Day 7 and 21. The study authors mention that also necrosis was observed 48 and 72 hours and 7 days after test item instillation, but not at the the 14- and 21-day reading time point. In general necrosis is irreversibel, therefore it is unclear if the table in the study report is correct.

Any other information on results incl. tables

Irritation/corrosive response data at each reading time point up to removal of animal from the test

	1h	24h	48h	72h	7d	14d	21d	Mean (24h, 48h, 72h)	Max. score:
Conjunctivae   redness	1	2	3	3	2	0	0	2,67	3
Conjunctivae  chemosis	2	2	2	1	1	1	0	1,67	4
Iris	+	1	1	1	0	0	0	1,00	2
Cornea opacity *)	3	2^d,f	3^f	3^f	3^b,c,f	4^b,c,e,f	3^b	2,67	4

*)At all scorings whole cornea (area score 4) affected

b: Pannus; c: Protruding cornea; d: Discharge tinted yellow; e: red mass (2x3 mm) on cornea; f: Observation confirmed with fluorescein

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

CLP: Eye Damage 1, H318 according to Regulation (EC) No. 1272/2008.