Propanamide, 2-hydroxy-N,N-dimethyl-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006/12/20-2007/01/02

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline compliant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(2002)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(2002)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-hydroxy-N,N-dimethylpropanamide

EC Number:

609-066-0

Cas Number:

35123-06-9

Molecular formula:

C5H11NO2

IUPAC Name:

2-hydroxy-N,N-dimethylpropanamide

Test material form:

other: liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Netherlands BV, Kreuzelweg 53, NL-5961 NM Horst / The Netherlands
- Age at study initiation: 11 weeks (male), 11−12 weeks (females)
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd, Füllinsdorf) and haysticks 4642 (batch no. 77/05, Provimi Kliba AG) were provided for gnawing.
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet, ad libitum, provided by Provimi Kliba AG, 4303 Kaiseraugst Switzerland
- Water: tap water

ENVIRONMENTAL CONDITIONS
- Temperature: 17 - 23 °C
- Humidity: 30 - 70 %
- Air changes: 10 - 15 air changes per hour
- Photoperiod: 12 hours light and 12 hours dark

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
0.1 mL (per animal) of test item was measured with a syringe and applied undiluted. The pH of the test item was measured and was found to be 10.69.

Duration of treatment / exposure:

0.1 mL of test item was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. The treated eyes were not rinsed after instillation. As it was suspected that the test item might produce irritancy, a single animal (one female) was treated first.

Observation period (in vivo):

24 hours

Number of animals or in vitro replicates:

3 males and 3 females

Details on study design:

SCORING SYSTEM: The eye reactions were assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004. Scleral reddening and ocular discharge were also assessed.

TOOL USED TO ASSESS SCORE: Eye examinations were made with a Varta Cliptrix diagnostic-lamp (Roth AG, CH-4153 Reinach/Switzerland).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal 1,2,3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal 1, 2, 3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals. Moderate reddening of the conjunctivae was noted in the treated eyes of all animals one hour after test item instillation. The reddening persisted as moderate in two animals on the following day and had faded into slight in one animal at this time. Slight reddening of the conjunctivae was still present in the treated eyes of the three animals at the 48- hour reading. Obvious swelling (chemosis) of the conjunctivae with partial eversion of the lids was observed in two of the animals one hour after the treatment. The swelling persisted as slight in one animal at the 24- hour examination. Moderate or slight reddening of the sclerae was present in all test animals at the 1- hour reading and persisted in two animals still in the 24- hour evaluation. Slight or moderate ocular discharge was noted in the three test animals one hour after instillation was still present in one animal at the 24- hour reading. No abnormal findings were observed in the treated eye of any animal 72 hours after treatment at the end of the observation period for all animals. No staining of the eyes or test item remnants were noted at any examination. No corrosion of the cornea was observed at any of the reading times. The bod weights of all rabbits were considered to be within the normal range of variability.

Other effects:

none

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information