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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004-11-29 to 2004-12-28
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:
2005

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Glycine, N-methyl-, N-coco acyl derivs., sodium salts
EC Number:
263-193-2
EC Name:
Glycine, N-methyl-, N-coco acyl derivs., sodium salts
Cas Number:
61791-59-1
Molecular formula:
Not applicable
IUPAC Name:
disodium 2-(N-methyldodecanamido)acetate 2-(N-methyltetradecanamido)acetate
Test material form:
not specified

Test animals / tissue source

Species:
rabbit
Strain:
other: SPF albino rabbits of the stock Chbb:HM
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: DIMED Schönwalde GmbH, Schönwalde, Germany
- Age at study initiation: approximately 8 months
- Weight at study initiation: 2100-2200 g
- Housing: three male rabbits were caged individually in a polyphenyl (PPE) cage
- Diet: pelleted Altromin 2123, Lage, Lippe, ad libitum
- Water: (tap/filtered) water, 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:
0.1 mL
Duration of treatment / exposure:
24 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:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE:
- Washing: The treated eye was rinsed with 20 mL 0.9% sodium chloride solution
- Time after start of exposure: 24 h
SCORING SYSTEM:
- Draize scoring system
TOOL USED TO ASSESS SCORE:
- fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritant / corrosive response data:
- 1 h after the application of the test item the animals showed scattered or diffuse areas of opacity with details of iris clearly visible on more than one quarter of the cornea area, a conjunctiva with diffuse, crimson colour and individual vessels not easily discernible, a swelling above normal and a flow of tears around the whole eye were observed.
- 24 h after the application of the test item the animals showed scattered or diffuse areas of opacity with details of iris clearly visible on more than one half of the cornea area, an iris with markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia and existence of reaction to light, a conjunctiva with diffuse beefy red and an obvious swelling with partial eversion of lids were observed.
- 48 h after the application of the test item the animals showed scattered or diffuse areas of opacity with details of iris clearly visible on more than one half of the cornea area, an iris with markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia and existence of reaction to light, a conjunctiva with diffuse beefy red and an obvious swelling with partial eversion of lids were observed.
- 72 h after the application of the test item the animals showed scattered or diffuse areas of opacity with details of iris clearly visible on more than one half of the cornea area, an iris with markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia and existence of reaction to light, a conjunctiva with diffuse, crimson colour and individual vessels not easily discernible as well as an obvious swelling with partial eversion of lids were observed.
- 7 days after the application of the test item the animals showed scattered or diffuse areas of opacity with details of iris clearly visible on more than half of the cornea area, some hyperaemic, conjunctival blood vessels and a swelling above normal were observed.
- 14 days after the application of the test item all animals showed scattered or diffuse areas of opacity with details of iris clearly visible on about one quarter of the cornea area.
- the eye irritating effects were fully reversible within 21 days.

Any other information on results incl. tables

Table 1: Summary of eye irritation study

Rabbit #

 

Time [h]

 

conjunctivae

 

iris

 

cornea

 

 

conjunctivae

 

iris

 

cornea

 

redness

swelling

redness

swelling

1

 

 

 

 

1

2

1

0

1

 

24

3

2

1

1

48

3

2

1

1

72

2

2

1

1

average

2,67

2

1

1

Time to reversion

14 days

14 days

7 days

14 days

2

 

 

 

 

1

2

1

1

1

 

 

24

3

1

1

1

48

3

1

1

1

72

2

1

1

1

average

2.67

1.0

1.0

1.0

Time to reversion

7 days

7 days

7 days

21 days

3

 

 

 

 

1

2

1

1

1

 

 

24

2

1

1

2

48

2

1

1

1

72

1

1

1

1

average

1.67

1.0

1.0

1.33

Time to reversion

14 days

14 days

14 days

14 days

Applicant's summary and conclusion

Interpretation of results:
other: Eye irrit. 2, H319. Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).
Conclusions:
SCL:
> 30%: Eye dam. Category 1 (H318)
≤ 30% and > 1%: Eye irrit. Category 2 (H319)