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EC number: 620-174-7 | CAS number: 1079184-43-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1986-03-17 to 1986-03-24
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- -10 mg solid dose instead of 100 mg as specfied by OECD 405 guidelines
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ethanaminium, 2-hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl-, esters with C16-18 and C18-unsatd. fatty acids, chlorides
- Cas Number:
- 1079184-43-2
- Molecular formula:
- n.a. (UVCB)
- IUPAC Name:
- Ethanaminium, 2-hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl-, esters with C16-18 and C18-unsatd. fatty acids, chlorides
- Reference substance name:
- Propan-2-ol
- EC Number:
- 200-661-7
- EC Name:
- Propan-2-ol
- Cas Number:
- 67-63-0
- Molecular formula:
- C3H8O
- IUPAC Name:
- propan-2-ol
- Test material form:
- solid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Diethylester dimethyl ammonium chloride
- Substance type: Waxy
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Buckmasters, Henham,Hartfordshire, England
- Age at study initiation: 10-14 weeks
- Weight at study initiation: 2.3-3.2 kg
- Housing: Metal cages with perforated floors
- Diet (e.g. ad libitum): SDS standerd Rabbit Diet,ad libitum
- Water (e.g. ad libitum): Tap water,ad libitum
- Acclimation period:Not given
ENVIRONMENTAL CONDITIONS
- Temperature (°C):19 °C
- Humidity (%): 30-70%
- Air changes (per hr): 19 air charges /hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light in each 24 hrs period.
IN-LIFE DATES: From:1986-03-17 To: 1986-03-24
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Counter lateral eye.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mg, eye non rinsed
- Concentration (if solution): Not Applicable
VEHICLE
- Amount(s) applied (volume or weight with unit): Not Applicable
- Concentration (if solution): Not Applicable
- Lot/batch no. (if required): Not Applicable
- Purity: Not Applicable - Duration of treatment / exposure:
- 4 seconds in Group 2 and 7 days in Group 1
- Observation period (in vivo):
- 24, 48, 72 hrs, 4, and 7 days after instillation for Group I and Group 2.
- Number of animals or in vitro replicates:
- Group 1: 6 Rabbits (10 mg undiluted test material, non-rinsed),
Group 2: 3 Rabbits (10mg undiluted test material, rinsed 4 seconds after instillation) - Details on study design:
- The test substance is placed directly on the cornea of rabbit eye
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Group 1 unwashed, Group 2 washing with 20 ml of lukewarm tap water.
- Time after start of exposure: 4 seconds in Group 2
SCORING SYSTEM: Draize Scoring system.
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- 10 mg undiluted test material non-rinsed
- Basis:
- animal: #1 - #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- 10 mg undiluted test material non-rinsed
- Basis:
- animal: #1 - #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- 10 mg undiluted test material non-rinsed
- Basis:
- animal: #1 - #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- 10 mg undiluted test material non-rinsed
- Basis:
- animal: #1 - #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- 10 mg undiluted test material rinsed group
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- 10 mg undiluted test material rinsed group
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- 10 mg undiluted test material rinsed group
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- 10 mg undiluted test material rinsed group
- Basis:
- animal: #1, #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Remarks:
- 10 mg undiluted test material rinsed group
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The eyes of two respective group of 6 and 3 rabbits were instilled with 10 mg of undiluted test substance. The eyes of the first group of 6 rabbits were not rinsed and the second group of 3 rabbits were rinsed. No ocular irritation was observed in the non-rinsed group of 6 rabbits 24 hours after instillation. Mild conjunctival redness (overall ocular irritation score was 0.67 at 24 hours) was observed in the eyes of 2/3 rabbits in the 10 mg rinsed group that cleared by 48 hours.
- Other effects:
- None observed.
Any other information on results incl. tables
Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test group 1 (not rinsed)
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
- |
- |
- |
- |
24 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
48 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
72 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0 |
0 |
0 |
0 |
Area effected |
|
|
|
|
Maximum average score (including area affected, max 110) |
|
|
|
|
Reversibility*) |
C |
C |
C |
C |
Average time (unit) for reversion |
|
|
|
|
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test group 2 (rinsed)
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
- |
- |
- |
- |
24 h |
0/0/0 |
0/0/0 |
1/0/1 |
0/0/0 |
48 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0 |
0 |
0.33/0/0.33 |
0 |
Area effected |
|
|
|
|
Maximum average score (including area affected, max 110) |
|
|
|
|
Reversibility*) |
C |
C |
C |
C |
Average time (unit) for reversion |
|
|
|
|
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- No occular irritation was observed in the non-rinsed group.
A very slight irritation was observed untill the 24 hour reading with max. scores of 1 for conjunctivae. All symptomes were reversible at the 48 hour reading. - Executive summary:
In a primary eye irritation study comparable to OECD guideline 405,10 mg of MDEA-Esterquat C16-18 and C18 unsatd. was directly applied onto the cornea of one eye of six young adult New Zealand rabbits each and observed for 7 days. A subgroup of 3 additional rabbits was treated in the same matter, but eyes were rinsed 4 sec. after instillation of test substance.
Animals then were observed for 7 days. Irritation was scored by the method of Draize.
In the main group no eye irritation was observed, all readings were zero. Mild conjunctival redness (score 1) was observed in 2/3 rabbits of subgroup (rinsed group)after 24 hours and was reversible within 48 hours.
No information on content of active ingredient of the test substance in this study report. However, according to producer information test substance has 80 % a.i.
In this study, MDEA-Esterquat C16-18 and C18 unsatd. is not an eye irritant.
Due to the low volume applied, the results of this study are not adequate for classification and labelling purposes.
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