Dipropoxymethane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 2010-03-22 to 2010-03-29

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Propylal

IUPAC Name:

Propylal

Details on test material:

- Name of test material (as cited in study report): propylal
- Physical state: colourless liquid
- Analytical purity: 99.80% (w/w)
- Impurities (identity and concentrations): propan-1-ol (0.031%); aldehydes (not found); water (0.0231%)
- Lot/batch No.: 0803211700
- Expiration date of the lot/batch: 21/03/2011
- Storage condition of test material: stored in a closed brown glass vial at laboratory temperature during the study

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: breeding farm VELAZ s.r.o., Kolec u Kladna, Czech Republic, RCH CZ 21760152
- Age at study initiation: 4-5 months
- Weight at study initiation: 3.4-3.7 kg
- Housing: Conventional animal room – individually in metallic cages
- Diet (e.g. ad libitum): Standard pelleted diet TM-MAK 1 for rabbits and guinea pigs ad libidum (producer: Ing. Mrkvicka Miroslav – Vyroba krmnych smesi, Mlyn Kocanda, 252 42 Jesenice u Prahy)
- Water (e.g. ad libitum): Drinking tap water ad libitum (quality corresponding to the Regulation No.: 252/2004 Czech Coll. Of Law)
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C, permanently monitored
- Humidity (%): 30 – 70%, permanently monitored
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1g
- Concentration (if solution): Not relevant

VEHICLE
- Amount(s) applied (volume or weight with unit): Not relevant
- Concentration (if solution): Not relevant
- Lot/batch no. (if required): Not relevant
- Purity: Not relevant

Duration of treatment / exposure:

Duration of exposure corresponds to duration of observation

Observation period (in vivo):

The eyes were examined at 1, 24, 48 and 72 hours after application, then once daily. After recording the observations at 24 hours, the eyes of rabbit were examined with the aid of fluorescinein and the ophthamoscopy. The grades of ocular reaction for single animal (observation of conjunctivae, cornea and iris) were recorded at each examination.

Number of animals or in vitro replicates:

3 (1 male and 2 females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: Not relevant

SCORING SYSTEM:
CORNEA
0 - No ulceration or opacity
1 - Scattered or diffuse areas of opacity; details of iris clearly visible
2 - Easily discernible translucent area;details of iris slightly obscured
3 – Nacrous area, no details of iris visible, size of pupil barely discernible
4 – Opaque cornea, iris not discernible through the opacy
Maximum possible: 4

IRIS
0 - Normal
1 – Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperemia ; or injection ; iris reactive to light (a sluggish reaction is considered to be an effect)
2 – Hemorrhage, gross destruction, or no reaction to light
Maximum possible: 2

CONJUNCTIVAE
0 - Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris) normal
1 - Some blood vessels hyperarmic (injected)
2 - Diffuse, crimson color, individual vessels not easily discernible
3 - Diffuse beefy red
Maximum possible: 3

CHEMOSIS
0 - Normal no alterations
1 - Some swelling above normal
2 - Obvious swelling with partial eversion of lids
3- Swelling with lids about half closed
4 - Swelling with lids more than half closed
Maximum possible: 4

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #7, #8 and #9

Time point:

other: 1h, 24h, 48h and 72h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

iris score

Basis:

animal: #7, #8 and #9

Time point:

other: 1h, 24h, 48h and 72h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #7

Time point:

other: 1h and 24h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 4 days

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: #7

Time point:

other: 48h and 72h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 4 days

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: #8

Time point:

other: 1h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 48h

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal: #8

Time point:

other: 24h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 48h

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal: #9

Time point:

other: 1h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 5 days

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal: #9

Time point:

other: 24h, 48h and 72h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 5 days

Results 9

Irritation parameter:

chemosis score

Basis:

animal: #7, #8 and #9

Time point:

other: 1h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 24h

Irritant / corrosive response data:

Please refer to "Overall irritation/corrosion results"

Other effects:

Clinical observation and body weight are recorded under "Any other information on results incl. tables"

Any other information on results incl. tables

Clinical observation and body weight were recorded in the table below:

Rabbit No.	Clinical observation	Body weight (in kg)
		prior to application	at termination
7	No changes	2.40	2.60
8	No changes	2.40	2.70
9	No changes	2.30	2.50

No symptoms of systemic toxicity were observed in the animals during clinical observation in the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Examination of eye irritation after single application demonstrated, that the test substance, prpopylal, was slightly irritating for eye of rabbit, but all signs of irritation disappeared till 5th day afer exposure.

Executive summary:

The test substance, propylal, was tested for the assessment of eye irritation/corrosion effects using albino rabbit (New Zealand Albino breed).

The test was performed according to the Method B.5 Acute Toxicity: Eye Irritation/Corrosion. Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.

The test was performed initially using one animal (No. 7). If the results of this test indicate the substance to be corrosive or a severe irritant to the eye, the response was confirmed using two additional animals (No. 8 and No. 9).

The following changes were observed on eye at 1 hour after application: conjunctivae - diffuse, crimson color, individual vessels not easily discernible; chemosis – some swelling above normal in all rabbits. In one rabbit (No. 9) lacrimation was observed at 1 hour after application. Conjunctivae – diffuse, crimson color, individual vessels not easily discernible or some blood vessels hyperaemic (injected) were observed in all rabbits at the 24 hours after application. Conjunctivae – some blood vessels hyperaemic (injected) were observed in two rabbits at the 48 and 72 hours after application. Changes on the conjunctivae in one animal (No. 9) persisted to the 4th day after application. On the 5th day no alterations appeared. No clinical signs of systemic intoxication were detected.

 

Examination of eye irritation after single application demonstrated, that the test substance, prpopylal, was slightly irritating for eye of rabbit, but all signs of irritation disappeared till 5th day afer exposure.