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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
05 Apr – 12 Apr 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Final report on the Safety Assessment of Cocoyl Sarcosine, Lauroyl Sarcosine, Myristoyl Sarcosine, Oleoyl Sarcosine, Stearoyl Sarcosine, Sodium Cocoyl Sarcosinate, Sodium Lauroyl Sarcosinate, Sodium Myristoyl Sarcosinate, Ammonium Cocoyl Sarcosinate, and
Author:
Cosmetic Ingredient Review Panel
Year:
2001
Bibliographic source:
Int J Toxicol 20( 1):1-14
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
limited data on test substance
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate
EC Number:
250-151-3
EC Name:
Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate
Cas Number:
30364-51-3
Molecular formula:
C17H33NO3.Na
IUPAC Name:
sodium N-methyl-N-(1-oxotetradecyl)aminoacetate
Test material form:
other: aqueous formulation

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ace Animals. Inc., Boyertown, PA, USA
- Age at study initiation: young adults
- Weight at study initiation: 2-3 kg
- Housing: animals were housed individually in wire mesh bottom cages.
- Diet: NIH 09 Rabbit Ration (Zeigler Brothers, Inc., Gardners, PA, USA), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Environment-controlled rooms per "Guide for the Care and Use of Laboratory Animals"DHEW Publication No. (NIH) 85-23.
- 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 mL
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
7 days
Reading time points: 24, 48 and 72 h and 7 days
Number of animals or in vitro replicates:
6
Details on study design:
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:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
2.06
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0.72
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
2.83
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
All animals showed positive ocular response following test article instillation. The untreated eyes of all animals showed no effects except of one animal which exhibited diffuse areas of corneal opacity at the 24 and 48 h reading.
After 7 days, effects were still apparent in 4/6, 2/6, 6/6 and 5/6 animals on cornea, iris, conjunctivae redness and concjunctivae, respectively.

Any other information on results incl. tables

 Table 1. Results of eye irritation study.

Rabbit #

Time [h]

conjunctivae

 

iris

cornea

redness

swelling

1

24

2

1

0

2

48

3

2

1

2

72

2

2

1

2

7 days

1

1

0

1

average

2.3

1.7

0.7

2.0

2

24

3

3

1

2

48

3

3

1

2

72

3

3

0

2

7 days

3

1

0

2

average

3.0

3.0

0.7

2.0

3

24

3

3

1

2

48

3

3

1

2

72

2

2

1

2

7 days

1

1

0

0

average

2.7

2.7

1.0

2.0

4

24

3

2

1

2

48

3

2

0

2

72

3

2

1

2

7 days

3

1

1

2

average

3.0

2.0

0.7

2.0

5

24

3

2

1

2

48

3

3

1

2

72

3

3

1

3

7 days

3

2

2

4

average

3.0

2.7

1.0

2.3

6

24

3

2

0

2

48

3

2

0

2

72

3

2

1

2

7 days

1

0

0

0

average

3.0

2.0

0.3

2.0

 

average
score

Time [h]

conjunctivae

 

iris

cornea

 

redness

swelling

 

 

24

2.83

2.17

0.67

2.00

48

3.00

2.50

0.67

2.00

72

2.67

2.33

0.83

2.17

24+48+72

2.83

2.33

0.72

2.06

 

Applicant's summary and conclusion

Interpretation of results:
other: Eye damage 1, H318. Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).
Conclusions:
In the present study irreversible effects within a shorter observation period were observed in all animals. Classification as Eye Damage Category 1 was based on an expert judgement considering a worst case assumption.

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