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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study according to GLP
Cross-reference
Reason / purpose for cross-reference:
assessment report
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study according to GLP
Justification for type of information:
Justification for read-across is provided in chapter 13 as separate statement
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Netherlands BV
- Age at study initiation: 15 weeks (male), 16 weeks (females)
- Weight at study initiation: 2.4 kg (male), 2.5 - 2.6 kg (females)
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hour dark / light cycle
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

SCORING SYSTEM: numerical scoring system according Council Regulation (EC) 440/2008

TOOL USED TO ASSESS SCORE: fluorescein, diagnostic-lamp
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no signs of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no signs of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no signs of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no signs of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no signs of irritation
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no signs of irritation
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no signs of irritation
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no signs of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
1.77
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
1.77
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible

Eye Irritation Scores

Reading time

Animal

Opacity

Iris

Conjunctivae

Redness

Chemosis

1h

1

d

1

2

3

2

d

1

2

2

3

d

1

2

2

24 hours

1

1

1

3

3

2

1

1

3

2

3

1

1

3

3

48 hours

1

2

1

3

2

2

2

1

3

3

3

2

1

3

3

72 hours

1

2

1

2

1

2

3

1

3

2

3

2

1

3

3

7 day

1

0

0

0

0

2

1v

1

2

1

3

0

1

1c

1

14 day

1

0

0

0

0

2

0

0

0c

0

3

0

0

0c

0

d = dulling of the normal lustre of the corneal surface

v = vascularization of the cornea

c = convulted eyelids
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The eye irritation property of the registration substance is assessed based on the read-across to Sodium N-cocoyl glycinate.
Sodium N-cocoyl glycinate was investigated for its eye irritation property according to the Guideline OECD 405. It induced adverse effects in eyes that were reversible within 14 days. It is irritating to eyes.
Likewise, the registration substance is irritating to eyes.
Executive summary:

The eye irritation property of the registration substance is assessed based on the read-across to Sodium N-cocoyl glycinate.
Sodium N-cocoyl glycinate was investigated for its eye irritation property according to the Guideline OECD 405. It induced adverse effects in eyes that were reversible within 14 days. It is irritating to eyes.
Likewise, the registration substance is irritating to eyes.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Sodium cocoyl glycinate (SCG) [INCI]
IUPAC Name:
Sodium cocoyl glycinate (SCG) [INCI]

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
- Age at study initiation: 15 weeks (male), 16 weeks (females)
- Weight at study initiation: 2.4 kg (male), 2.5 - 2.6 kg (females)
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hour dark / light cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

SCORING SYSTEM: numerical scoring system according Council Regulation (EC) 440/2008

TOOL USED TO ASSESS SCORE: fluorescein, diagnostic-lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no signs of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no signs of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no signs of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no signs of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no signs of irritation
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no signs of irritation
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no signs of irritation
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no signs of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
1.77
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
1.77
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible

Any other information on results incl. tables

Eye Irritation Scores

Reading time

Animal

Opacity

Iris

Conjunctivae

Redness

Chemosis

1h

1

d

1

2

3

2

d

1

2

2

3

d

1

2

2

24 hours

1

1

1

3

3

2

1

1

3

2

3

1

1

3

3

48 hours

1

2

1

3

2

2

2

1

3

3

3

2

1

3

3

72 hours

1

2

1

2

1

2

3

1

3

2

3

2

1

3

3

7 day

1

0

0

0

0

2

1v

1

2

1

3

0

1

1c

1

14 day

1

0

0

0

0

2

0

0

0c

0

3

0

0

0c

0

d = dulling of the normal lustre of the corneal surface

v = vascularization of the cornea

c = convulted eyelids

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Sodium N-cocoyl glycinate was investigated for its eye irritation property according to the Guideline OECD 405. It induced adverse effects in eyes that were reversible within 14 days. It is irritating to eyes.
Executive summary:

Sodium N-cocoyl glycinate was investigated for its eye irritation property according to the Guideline OECD 405. The test material, 25% sodium N-cocoyl glycinate, was applied to eyes of rabbits. Three animals were used. In all treated animals clear irritating effects were found and these effects were reversible within 14 days. It is an eye irritant.