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Registration Dossier
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EC number: 268-938-5 | CAS number: 68155-09-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 1987 - May 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- The irritant potential of four amphoteric surfactants was assessed.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Amides, coco, N-[3-(dimethylamino)propyl], N-oxides
- EC Number:
- 268-938-5
- EC Name:
- Amides, coco, N-[3-(dimethylamino)propyl], N-oxides
- Cas Number:
- 68155-09-9
- Molecular formula:
- Unspecified
- IUPAC Name:
- Amides, coco, N-[3-(dimethylamino)propyl], N-oxides
Constituent 1
- Specific details on test material used for the study:
- The test substance was used with adjusted 25% active matter.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: chbb:HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Age at study initiation: 2115.0 to 2412.5 g
- Sex: males
Test system
- Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- 0.1 ml of test substance (25% active matter)
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1, 6, 24, 48, 72 h and 7, 10, 14, 17, 21 days
- Number of animals or in vitro replicates:
- four animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- not specified
SCORING SYSTEM: The reactions on cornea, iris and conjunctiva were assessed according to the scoring system by Draize.
TOOL USED TO ASSESS SCORE: 0.5% fluorescein solution
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: opacity area
- Basis:
- animal #3
- Time point:
- 21 d
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- other: opacity area
- Basis:
- animal #4
- Time point:
- 21 d
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- other: opacity area
- Basis:
- animal #1
- Time point:
- 21 d
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Corneal reactions which persisted for 21 days were observed in three test animals treated with the test substance. One animal treated with the test substance revealed irreversible corneal damage after 21 days. Reactions to the iris were not observed. Conjunctival reactions were severe and persisted for 21 days after application in the majority of test animals (3/4) when rabbits were treated with the test substance.
Any other information on results incl. tables
Table 1: Corneal reactions to rabbit eyes after application of the test substance with 25% active matter
Animal number |
Hours after application |
Days after application |
|||||||||||||||||||||||
1 |
6 |
24 |
48 |
72 |
7 |
10 |
14 |
17 |
21 |
||||||||||||||||
A |
B |
A |
B |
A |
B |
A |
B |
A |
B |
A |
B |
A |
B |
A |
B |
A |
B |
A |
B |
||||||
543 |
0 |
0 |
1 |
2 |
1 |
4 |
1 |
4 |
1 |
3 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|||||
588 |
1 |
2 |
1 |
2 |
1 |
4 |
1 |
4 |
1 |
4 |
1 |
2 |
1 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|||||
589 |
1 |
2 |
1 |
2 |
1 |
4 |
1 |
4 |
1 |
4 |
1 |
4 |
1 |
4 |
1 |
4 |
1 |
4 |
1 |
4 |
|||||
590 |
1 |
2 |
1 |
4 |
1 |
4 |
1 |
4 |
1 |
4 |
1 |
4 |
1 |
4 |
1 |
4 |
1 |
4 |
1 |
4 |
|||||
A (mean) |
0.75 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
0.75 |
0.75 |
0.75 |
0.75 |
|||||||||||||||
B (mean) |
1.50 |
2.50 |
4.00 |
4.00 |
3.75 |
3.00 |
2.75 |
2.25 |
2.25 |
2.25 |
|||||||||||||||
A = opacity grade; B = opacity area
Table 2: Conjunctiva reactions to rabbit eyes after application of the undiluted test substance
Animal number |
Hours after application |
Days after application |
||||||||||||||||||||||||||||
1 |
6 |
24 |
48 |
72 |
7 |
10 |
14 |
17 |
21 |
|||||||||||||||||||||
A |
B |
C |
A |
B |
C |
A |
B |
C |
A |
B |
C |
A |
B |
C |
A |
B |
C |
A |
B |
C |
A |
B |
C |
A |
B |
C |
A |
B |
C |
|
543 |
1 |
2 |
3 |
1 |
2 |
3 |
2 |
1 |
3 |
3 |
2 |
3 |
3 |
1 |
3 |
2 |
1 |
3 |
1 |
0 |
1 |
1 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
588 |
1 |
1 |
3 |
1 |
1 |
3 |
3 |
1 |
3 |
3 |
1 |
3 |
3 |
1 |
3 |
2 |
1 |
3 |
2 |
0 |
3 |
2 |
0 |
1 |
2 |
0 |
1 |
1 |
0 |
3 |
589 |
2 |
1 |
3 |
1 |
1 |
3 |
2 |
1 |
3 |
3 |
1 |
3 |
3 |
1 |
3 |
3 |
1 |
3 |
3 |
1 |
3 |
2 |
0 |
1 |
2 |
0 |
2 |
2 |
0 |
1 |
590 |
1 |
2 |
3 |
2 |
1 |
3 |
3 |
1 |
3 |
2 |
1 |
3 |
2 |
1 |
3 |
2 |
0 |
1 |
2 |
0 |
1 |
2 |
0 |
1 |
2 |
0 |
1 |
1 |
0 |
3 |
A (mean) |
0.75 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
0.75 |
0.75 |
0.75 |
0.75 |
||||||||||||||||||||
B (mean) |
1.50 |
2.50 |
4.00 |
4.00 |
3.75 |
3.00 |
2.75 |
2.25 |
2.25 |
2.25 |
||||||||||||||||||||
A = erythema; B = chemosis; C = exudation; red bold = bloody; bold = bloody infiltrated
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The results generated by the performed study concludes the test substance to be severly irritant to the mucous membrane of the eyes with irreversible damages to the cornea and the conjuctiva. Thus, the test substance must be labelled with the R-phrase R-41.
- Executive summary:
Three amphonic surfactants and the test substance wre tested in a concentration of 25% active ingredient for their primary eye irritation on rabbits by a single application and permanent contact (Method: Off. J. Europ. Commun. 27, L 251, 1984 p. 109 - 112 and Guidelines for Testing of Chemicals, Section 4, No 405, OECD). In each group were animals with corneal lesions, which had to be regarded as irreversible. All 4 test samples had to be signed with the risk phrases R-41.
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