Registration Dossier
Registration Dossier
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EC number: 250-151-3 | CAS number: 30364-51-3
Eye irritation
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:
- 2 001
- Bibliographic source:
- Int J Toxicol 20( 1):1-14
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- 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
- 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
Constituent 1
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 |
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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