Reaction mass of stearoyl sarcosine and palmitoyl sarcosine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 Nov - 23 Dec 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted in 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted in 2008

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-(1-oxooctadecyl)sarcosine

EC Number:

205-539-7

EC Name:

N-(1-oxooctadecyl)sarcosine

Cas Number:

142-48-3

Molecular formula:

C21H41NO3

IUPAC Name:

N-methyl-N-stearoylglycine

Test material form:

other: solid

Test animals / tissue source

Species:

rabbit

Strain:

other: SPF albino of the stock Chbb:HM

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kißlegg, Germany
- Age at study initiation: approximately 15- 33 months
- Weight at study initiation: 2.7 kg (mean)
- Housing: animals were caged individually in PPO caged with perforated floor
- Diet: pelleted complete rabbit diet “Altromin 2123”, ad libitum
- Water: tap water, ad libitum
- Acclimation period: approx. one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
 

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

1h

Observation period (in vivo):

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

Number of animals or in vitro replicates:

3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiologic saline solution
- Time after start of exposure: 1h

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:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks:

within 21 days

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks:

within 21 days

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible

Remarks:

within 7 days

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible

Remarks:

within 7 days

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 21 days

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 21 days

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 21 days

Irritant / corrosive response data:

One hour after application of the test material one test animal showed punctate or opacity with clearly identifiable details of iris to about a quarter of the cornea, some hyperemia, conjunctival blood vessels to about a swelling more than normal. In two further animals, punctate or diffuse areas of opacity were observed with clearly identifiable details of iris on more than three-quarters of the corneal surface, some hyperemia, conjunctival blood vessels and swelling more than normal.
24 hours after application of the test material all three animals showed punctate or diffuse areas of opacity with clearly identifiable details of iris on more than three-quarters of the surface of the cornea, an iris with significantly deepen rugae, congestion, swelling, moderate circumcorneal hyperemia and existing light reaction, a conjunctiva with diffuse crimson color and difficult to identify individual vessels and a marked swelling with partial eversion the eyelids. In addition, whitish secretion to the entire eye of one animal, and in the corner of the eye, in two further animals was observed.
After the installation of fluorescein animals all three animals showed punctate or diffuse areas of opacity with clearly identifiable details of iris on more than three-quarters of the corneal surface.
48 h after administration of the test material, in one animal punctate or diffuse areas of opacity with clearly identifiable details of iris on more than three-quarters of the surface of the cornea, an iris with significantly deepen rugae, congestion, swelling, moderate circumcorneal hyperemia and existing light reaction, a conjunctiva with diffuse crimson color and difficult to identify individual vessels, a marked swelling with partial eversion of the lids and whitish secretions around the entire eye were observed. A second animal showed punctate or diffuse areas of opacity with clearly identifiable details of iris on more than three-quarters of the surface of the cornea, an iris with significantly deepen rugae, congestion, swelling, moderate circumcorneal hyperemia and existing light reaction, a conjunctiva with diffuse crimson color and are difficult to detect individual vessels, a significant swelling with partial eversion of the lids and whitish secretion in the corner of the eye. In a third animal punctate or diffuse areas of opacity with clearly identifiable details of iris on more than three-quarters of the corneal surface were noted.
72 h after administration of the test material in the first animal punctate or diffuse areas of opacity with clearly identifiable details of iris on more than three-quarters of the surface of the cornea, an iris with significantly deepen rugae, congestion, swelling, moderate circumcorneal hyperemia and existing light reaction, a conjunctiva observed with diffuse crimson color and difficult to identify individual vessels, a marked swelling with partial eversion of the lids whitish secretions around the eye were identified. A second animal showed punctate or diffuse areas of opacity with clearly identifiable details of iris on more than three-quarters of the corneal surface, a marked swelling with partial eversion of the lids and whitish secretion in the corner of the eye. In the third punctate or diffuse areas of opacity with clearly identifiable details of iris on more than three-quarters of the corneal surface, hyperemia and existing light reaction, some hyperemia, conjunctival blood vessels, swelling were observed more than normal and whitish secretion in corner of the eye.
After the instillation of fluorescein, the second and third animal showed punctate or diffuse areas of opacity with clearly identifiable details of iris on more than three-quarters of the corneal surface. In the first animal punctate or diffuse areas of opacity with clearly identifiable details of iris on more than half but less than three quarters of the corneal surface were observed.
7 days after the application of the test material the second animal showed punctate or diffuse areas of opacity with clearly identifiable details of iris on more than half but less than three quarters of the corneal surface in one animal were punctate or diffuse areas of opacity with clearly identifiable details of iris on more than one quarter, but less than half the surface of the cornea, conjunctival hyperemia observed some blood vessels and hair loss around the entire eye. One animal showed punctate or diffuse areas of opacity with clearly identifiable details of iris on more than three-quarters of the surface of the cornea, an iris with clear with significantly deepen rugae, congestion, swelling, moderate circumcorneal hyperemia and existing light reaction, a conjunctiva with diffuse crimson color and difficult to identify individual vessels and hair loss around the entire eye.
After the instillation of fluorescein one animal showed punctate or diffuse areas of opacity with clearly identifiable details of iris to about a quarter of the corneal surface. In two further animals punctate or diffuse areas of opacity with clearly identifiable details of iris on more than half but less than three quarters of the corneal surface were observed.
14 days after the application of the test material one animal circular vascularization on a cornea range between 6 and 3 hours, point-like or diffuse opacity range on more than three-quarters of the corneal surface, a hyperemic conjunctival blood vessels, swelling more al normal and white fluffy secretion. In another animal the medial canthus starting circular vascularization on a cornea range between 5 and 12 h and a cloudy and edematous cornea in the rest of the central region, punctate or diffuse areas of opacity on more than half but less than three quarters of the skin surface and some hyperemic conjunctival blood vessels were observed. One further animal was after 14 days free of signs of eye irritation.
After the instillation of fluorescein one animal showed punctate or diffuse areas of opacity on more than a quarter, but observed less than three quarters of the corneal surface and conjunctival hyperemia some blood vessels. A second animal was after 14 days free of signs of eye irritation.
After the instillation of fluorescein animal the first animal showed punctate or diffuse opacity on more al quarter, but less than half of the corneal surface. In a third animal 0 punctate or diffuse areas of opacity on more than half, but few as three quarters of the corneal surface were observed.
21 days after application of the test showed in one animal pannus over the entire corneal surface, white fluffy secret of the conjuctivae as well as point-like and diffuse areas of opacity for more than three-quarters of the corneal surface. The iris could not be seen due to the full vascularization on the cornea. In one animal vascularisation was observed on the cornea and punctate or diffuse opacity on more than half, but observed less than three quarters of the corneal surface.
After the instillation of fluorescein, two animals showed no punctate or diffuse areas of opacity to about a quarter of the corneal surface.

Any other information on results incl. tables

Table 1 Individual and mean scores of conjuctivae, iris and cornea

Animal N.	Time after treatment	Conjuctivae		Iris	Cornea
		Chemosis	Redness	Lesion	Opacity
1	24 h	2	2	1	1
	48 h	2	2	1	1
	72 h	2	2	1	1
	Mean	2	2	1	1
2	24 h	2	2	1	1
	48 h	2	2	1	1
	72 h	2	2	1	1
	Mean	2	2	1	1
3	24 h	2	2	1	1
	48 h	1	1	1	1
	72 h	1	1	1	1
	Mean	1.33	1.33	1	1

 

Applicant's summary and conclusion

Interpretation of results:

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