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EC number: 931-333-8 | CAS number: 147170-44-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-01-24 to 1986-06-02
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1984
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C8-18(even numbered) and C18 unsaturated acyl) derivs., hydroxides, inner salts
- EC Number:
- 931-333-8
- Cas Number:
- 147170-44-3
- Molecular formula:
- not applicable
- IUPAC Name:
- 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C8-18(even numbered) and C18 unsaturated acyl) derivs., hydroxides, inner salts
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- dihydrogen oxide
- Test material form:
- solid - liquid: aqueous solution
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Strain: Himalayan, termed in study report as Kleinrusse Chbb: HM
- Age at study initiation: no data
- Weight at study initiation: 2028 to 2092 g
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- no data
Test system
- Vehicle:
- water
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 5 % active substance
VEHICLE
- water - Duration of treatment / exposure:
- eyes were not rinsed after treatment
- Observation period (in vivo):
- 10 days
scorings at 1, 6, 24, 48, 72, 96 and 168 hour(s) and 10 days after test substance instillation - Number of animals or in vitro replicates:
- 4
- Details on study design:
- APPLICATION OF TEST SUBSTANCE
- 100 mg test substance was instilled into the conjunctival sac of the left eye. The untreated right eye served as control.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eyes were not rinsed after treatment
SCORING SYSTEM: as stipulated in Foods, Drugs and Cosmetics. Ass. of Food and Drug Officials of the U.S., pp. 49 - 52 (1959) (Draize scheme)
TOOL USED TO ASSESS SCORE: no tools mentioned
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: at 24 h whole cornea affected
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: at 24 h whole cornea affected
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: at 24 h whole cornea affected
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 96 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 168 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #4
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 168 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 96 h
- Irritation parameter:
- iris score
- Basis:
- animal: #3, #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- All animals showed 1 hour after treatment, cornea opacity score 1 which affected one quarter of the cornea (area score 1). Until the 24 h scoring cornea opacity worsened in one animal to score 2 and trespassed in all four animals to the whole cornea (area score 4). Cornea effects were fully reversible in one animals by the 48 h scoring and in the other three animals by the 72 h scoring. Iritis was singly seen in two of the four animals at the 24 h scoring. Conjunctival redness worsened in all animals from initial scores 1 or 2 to score 3 at the 24 and 48 h scorings and was fully reversible in one animal each by the 72 or 96 h scoring and in two animals by the 168 h scoring. Maximal chemosis was seen at the 6 h scoring with score 1 in one and score two in the other three animals and was fully reversible in one animal each by the 48 or 96 h scoring and in two animals by the 72 h scoring. All animals showed discharge formation, which had its maximum at the 6 h scoring and was fully reversible in the individually animals 72 to 168 h after treatment.
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea opacity |
Cornea area affected |
Iris |
Conjunctivae |
Chemosis |
Discharge |
Max. score: 4 |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
Max. score: 3 |
|
1h |
1/1/1/1 |
1/1/1/1 |
0/0/0/0 |
2/1/1/1 |
1/1/1/2 |
2/3/3/3 |
6 h |
1/1/1/1 |
1/4/1/4 |
0/0/0/0 |
2/2/2/2 |
1/2/2/2 |
3/3/3/3 |
24 h |
1/1/1/2 |
4/4/4/4 |
1/1/0/0 |
3/3/3/3 |
1/1/1/1 |
2/1/2/3 |
48 h |
1/0/1/1 |
2/0/1/2 |
0/0/0/0 |
3/3/3/3 |
0/1/1/1 |
1/1/1/2 |
72 h |
0/0/0/0 |
0/0/0/0 |
0/0/0/0 |
1/0/2/3 |
0/0/0/1 |
1/0/1/1 |
96 h |
0/0/0/0 |
0/0/0/0 |
0/0/0/0 |
0/0/1/2 |
0/0/0/0 |
0/0/0/1 |
168 h |
No data |
No data |
No data |
0/0/0/0 |
0/0/0/0 |
0/0/0/0 |
10 d |
No data |
No data |
No data |
0/0/0/0 |
0/0/0/0 |
0/0/0/0 |
Average 24h, 48h, 72h |
0.67/0.33/0.67/1 |
2/1.33/1.67/2 |
0.33/0.33/0/0 |
2.33/2/2.67/3 |
0.33/0.67/0.67/1 |
1.33/0.67/1.33/2 |
Reversibility*) |
c. |
c. |
c. |
c. |
c. |
c. |
Time for reversion (h) |
72/48/72/72 |
72/48/72/72 |
48/48/-/- |
96/72/168/168 |
48/72/72/96 |
96/72/96/168 |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Classification is based on effects on the cornea, iris and conjunctiva calculated as mean scores following grading at 24, 48 and 72 hours after instillation of the test material, in consideration of reversibility.
The test substance is considered to be irritating according to CLP, EU GHS (Regulation (EC) No 1272/2008). - Executive summary:
In a primary eye irritation study according to EU Method B.5 (1984) and OECD Guideline 405 (1981), 0.1 ml of Coco AAPB (5 % a.i. in water) was instilled into the conjunctival sac of four Himalayan rabbits. The treated eyes were not rinsed after test substance instillation. Animals were then observed for 10 days. Irritation was scored according to Draize.
All animals showed 1 hour after treatment, cornea opacity score 1 which affected one quarter of the cornea (area score 1). Until the 24 h scoring cornea opacity worsened in one animal to score 2 and trespassed in all four animals to the whole cornea (area score 4). Cornea effects were fully reversible in one animal by the 48 h scoring and in the other three animals by the 72 h scoring. Iritis was solely seen in two of the four animals at the 24 h scoring. Conjunctival redness worsened in all animals from initial scores 1 or 2 to score 3 at the 24 and 48 h scorings and was fully reversible in one animal each by the 72 or 96 h scoring and in two animals by the 168 h scoring. Maximal chemosis was seen at the 6 h scoring with score 1 in one and score two in the other three animals and was fully reversible in one animal each by the 48 or 96 h scoring and in two animals by the 72 h scoring. All animals showed discharge formation, which had its maximum at the 6 h scoring and was fully reversible in the individually animals 72 to 168 h after treatment.
In this study, Coco AAPB (5 % a.i. in water) is an eye irritant.
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