Ammonium N-methyl-N-(1-oxododecyl)glycinate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-11-08 to 2004-11-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2002

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium N-methyl-N-(1-oxododecyl)glycinate

EC Number:

268-130-2

EC Name:

Ammonium N-methyl-N-(1-oxododecyl)glycinate

Cas Number:

68003-46-3

Molecular formula:

C15H29NO3.H3N

IUPAC Name:

ammonium 2-(N-methyldodecanamido)acetate

Test material form:

other: liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: 4166310

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature

Test animals / tissue source

Species:

rabbit

Strain:

other: Albino rabbit (Chbb:HM)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS:
- Source: DIMED Schönwalde GmbH, Schönwalde, Germany
- Age at study initiation: 104 weeks
- Weight at study initiation: 2700 g
- Housing: individual female rabbit was caged in a polyphenyl ether (PPE) cage
- Diet: pelleted complete diet Altromin 2123 (Altromin GmbH, Lage, Germany), ad libitum
- Water: (tap/filtered) water acidified with hydrochloric acid, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

water

Controls:

other: The untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:

1 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 female

Details on study design:

REMOVAL OF TEST SUBSTANCE:
- Washing: The treated eye was rinsed with 40 mL 0.9% saline solution
- Time after start of exposure: 1 h

SCORING SYSTEM:
- Draize scoring system

TOOL USED TO ASSESS SCORE:
- fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 1 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 21 days

Remarks on result:

other: eye has been washed 1 h p.a. due to severe immediate effects

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 21 days

Remarks on result:

other: eye has been washed 1 h p.a. due to severe immediate effects

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 1 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 21 days

Remarks on result:

other: eye has been washed 1 h p.a. due to severe immediate effects

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 21 days

Remarks on result:

other: eye has been washed 1 h p.a. due to severe immediate effects

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 1 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 21 days

Remarks on result:

other: eye has been washed 1 h p.a. due to severe immediate effects

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 21 days

Remarks on result:

other: eye has been washed 1 h p.a. due to severe immediate effects

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 1 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 21 days

Remarks on result:

other: eye has been washed 1 h p.a. due to severe immediate effects

Results 8

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

Remarks on result:

other: eye has been washed 1 h p.a. due to severe immediate effects

Irritant / corrosive response data:

- The treated eye showed severe irritating/corrosive effects already 1 h after treatment with the test item. Therefore, the test item was washed out with 40 mL of 0.9% saline solution.
- Cornea, iris, conjunctivae and chemosis score were determined 1, 24, 48 and 72 h and 7, 14 and 21 days after removal of the test item.
- the eye irritating/corrosive effects were fully reversible within 21 days

Any other information on results incl. tables

Table 1: Summary of eye irritation scores

Animal-No./weight in kg	Irritation parameter	1 h	24 h	48 h	72 h	Mean	7 days	14 days	21 days
1 / 2,7	Cornea score (degree)   Cornea score (area)	3       4	2       4	2       4	2       4	2       4	1       3	0       0	0       0
	Iris score	2	1	1	1	1	1	0	0
	Conjunctivae score	3	2	2	2	2	1	1	0
	Chemosis score	3	3	1	1	1,67	0	0	0

Remark: Only time points 24, 48 and 72 h were used for calculation of mean value.

Applicant's summary and conclusion

Interpretation of results:

other: Eye damage 1, H318. Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).