Registration Dossier
Registration Dossier
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EC number: 931-292-6 | CAS number: 308062-28-4
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978-09-12 To 1978-10-18
- 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:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- Pre-GLP
Test material
- Reference substance name:
- Dodecyldimethylamine oxide
- EC Number:
- 216-700-6
- EC Name:
- Dodecyldimethylamine oxide
- Cas Number:
- 1643-20-5
- Molecular formula:
- C14H31NO
- IUPAC Name:
- dodecyl(dimethyl)amine oxide
- Reference substance name:
- N,N-dimethyltetradecylamine N-oxide
- EC Number:
- 222-059-3
- EC Name:
- N,N-dimethyltetradecylamine N-oxide
- Cas Number:
- 3332-27-2
- Molecular formula:
- C16H35NO
- IUPAC Name:
- dimethyl(tetradecyl)amine oxide
- Details on test material:
- - Name of test material (as cited in study report): P0434 (dodecyl dimethyl amine oxide)
- Molecular formula (if other than submission substance): Not available
- Molecular weight (if other than submission substance): 235.7
- Substance type: Pure active substance
- Physical state: Liquid
- Analytical purity: Not available
- Impurities (identity and concentrations): None
- Composition of test material, percentage of components: See below
- Isomers composition: Not available
- Purity test date: Not available
- Lot/batch No.: Not available
- Expiration date of the lot/batch: Not available
- Stability under test conditions: Not available
- Storage condition of test material: Room temperature
- Other: None
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kings Wheel
- Age at study initiation: Young adult
- Weight at study initiation: Males: 1608.6 gm, Females: 2031.5 gm
- Housing:Individually in stainless steel cages with stainless steel slatted flooring
- Diet (e.g. ad libitum): Purins Lab Rabbit Chow (By Ralston Purina Company)
- Water (e.g. ad libitum): Tap water, from bottles with tubules made of refined steel, ad libitum
- Acclimation period: minimum 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 46-72
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): 12/12 (Fluorescent lighting)
IN-LIFE DATES: From: 1978-09-12 To: 1978-10-18
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml P0434
- Concentration (if solution): Undiluted
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:
- Group I: Eyes of animals were not rinsed, and observations are noted directly.
Group II: Eyes of animals were rinsed after 4 seconds by spraying 20 ml of lukewarm tap water after application. - Observation period (in vivo):
- At 1 hour, 1,2,3,4,7,14,21,28 and 35 days.
- Number of animals or in vitro replicates:
- 3 animals of either sex per group.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Eyes of Group II animals were rinsed by spraying 20 ml of lukewarm tap water from a hypodermic syringe fitted with a snubbed 18 gauge needle into the eye under moderate pressure.
- Time after start of exposure: 4 seconds after application.
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: A Pen light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- till day 35. Vascularization was observed from day 21 onwards till the end of study (day 35)
- Remarks on result:
- other: No rinse
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Iris was normal throughout the study.
- Remarks on result:
- other: No rinse
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: No rinse
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: No rinse
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- till day 35. Vascularization was observed from day 21 onwards till the end of study (day 35)
- Remarks on result:
- other: No rinse
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Iris was normal throughout the study.
- Remarks on result:
- other: No rinse
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: No rinse
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: No rinse
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- till day 35. Vascularization was observed from day 21 onwards till the end of study (day 35)
- Remarks on result:
- other: No rinse
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Iris was normal throughout the study.
- Remarks on result:
- other: No rinse
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: No rinse
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Cornea was normal throughout the study
- Remarks on result:
- other: Rinse
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Iris was normal throughout the study.
- Remarks on result:
- other: Rinse
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Rinse
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Rinse
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: Rinse
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Rinse
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Iris was normal throughout the study.
- Remarks on result:
- other: Rinse
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: Rinse
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- till day 35. Vascularization was observed from day 21 onwards till the end of study (day 35)
- Remarks on result:
- other: Rinse
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Iris was normal throughout the study.
- Remarks on result:
- other: Rinse
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 20
- Reversibility:
- fully reversible within: 14 days
- Remarks:
- Vascularization was observed from day 21 onwards till the end of study (day 35)
- Remarks on result:
- other: Rinse
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: Rinse
- Other effects:
- None
Any other information on results incl. tables
Table 1: The eye irritation response of animals (Group I - No rinse) exposed to undiluted P0434 (27.8% DDAO) (study# 21599)
| Animal number | Observation time | Cornea | Cornea Score | Iris | Iris Score | Conjunctivae | Conjunctivae Score | |||
| A (Degree of density) | B (Area of cornea involved) | AxBx5 | A | Ax5 | A (Redness) | B (Chemosis) | C (Discharge) | A+B+Cx2 | ||
| Animal #1 | 1 hour | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 3 | 12 |
| Day 1 | 1 | 4 | 20 | 0 | 0 | 1 | 2 | 3 | 12 | |
| Day 2 | 1 | 4 | 20 | 0 | 0 | 1 | 2 | 2 | 10 | |
| Day 3 | 1 | 4 | 20 | 0 | 0 | 1 | 2 | 2 | 10 | |
| Day 4 | 1 | 4 | 20 | 0 | 0 | 1 | 2 | 1 | 8 | |
| Day 7 | 1 | 4 | 20 | 0 | 0 | 1 | 1 | 1 | 6 | |
| Day 14 | 1 | 4 | 20 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Day 21* | 1 | 4 | 20 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Day 28* | 2 | 4 | 40 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Day 35* | 2 | 4 | 40 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Animal #2 | 1 hour | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 3 | 12 |
| Day 1 | 1 | 4 | 20 | 0 | 0 | 1 | 2 | 2 | 12 | |
| Day 2 | 1 | 4 | 20 | 0 | 0 | 1 | 1 | 1 | 6 | |
| Day 3 | 1 | 4 | 20 | 0 | 0 | 1 | 1 | 1 | 6 | |
| Day 4 | 1 | 4 | 20 | 0 | 0 | 1 | 0 | 0 | 2 | |
| Day 7 | 1 | 4 | 20 | 0 | 0 | 1 | 0 | 0 | 2 | |
| Day 14 | 1 | 4 | 20 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Day 21* | 1 | 4 | 20 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Day 28* | 2 | 2 | 20 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Day 35* | 2 | 2 | 20 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Animal #3 | 1 hour | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 8 |
| Day 1 | 1 | 4 | 20 | 0 | 0 | 1 | 2 | 1 | 8 | |
| Day 2 | 1 | 4 | 20 | 0 | 0 | 1 | 1 | 1 | 6 | |
| Day 3 | 1 | 4 | 20 | 0 | 0 | 1 | 1 | 1 | 6 | |
| Day 4 | 1 | 4 | 20 | 0 | 0 | 1 | 1 | 1 | 6 | |
| Day 7 | 1 | 4 | 20 | 0 | 0 | 1 | 1 | 1 | 6 | |
| Day 14 | 1 | 4 | 20 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Day 21* | 1 | 4 | 20 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Day 28* | 1 | 4 | 20 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Day 35* | 1 | 4 | 20 | 0 | 0 | 0 | 0 | 0 | 0 | |
* Vascularization was observed. Vascularization refers to the invasion of the cornea by blood vessels.
Table 2: The eye irritation response of animals (Group II- Rinse) exposed toundiluted P0434 (27.8% DDAO) (study# 21599)
| Animal number | Observation time | Cornea | Cornea Score | Iris | Iris Score | Conjunctivae | Conjunctivae Score | |||
| A (Degree of density) | B (Area of cornea involved) | AxBx5 | A | Ax5 | A (Redness) | B (Chemosis) | C (Discharge) | A+B+Cx2 | ||
| Animal #4 | 1 hour | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 3 | 12 |
| Day 1 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 1 | 8 | |
| Day 2 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 4 | |
| Day 3 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 4 | |
| Day 4 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | |
| Day 7 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | |
| Day 14 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Animal #5 | 1 hour | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 2 | 10 |
| Day 1 | 1 | 1 | 5 | 0 | 0 | 1 | 2 | 1 | 8 | |
| Day 2 | 1 | 1 | 5 | 0 | 0 | 1 | 0 | 1 | 4 | |
| Day 3 | 1 | 1 | 5 | 0 | 0 | 1 | 0 | 1 | 4 | |
| Day 4 | 1 | 1 | 5 | 0 | 0 | 1 | 0 | 0 | 2 | |
| Day 7 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | |
| Day 14 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Animal #6 | 1 hour | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 3 | 12 |
| Day 1 | 1 | 2 | 10 | 0 | 0 | 1 | 2 | 1 | 8 | |
| Day 2 | 1 | 2 | 10 | 0 | 0 | 1 | 0 | 1 | 4 | |
| Day 3 | 1 | 2 | 10 | 0 | 0 | 1 | 0 | 2 | 6 | |
| Day 4 | 1 | 2 | 10 | 0 | 0 | 1 | 0 | 2 | 6 | |
| Day 7 | 1 | 3 | 15 | 0 | 0 | 1 | 0 | 2 | 6 | |
| Day 14 | 1 | 2 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Day 21* | 1 | 2 | 10 | 0 | 0 | 0 | 0 | 1 | 2 | |
| Day 28* | 1 | 2 | 10 | 0 | 0 | 0 | 0 | 1 | 2 | |
| Day 35* | 1 | 2 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | |
* Vascularization was observed. Vascularization refers to the invasion of the cornea by blood vessels.
Overall irritation/ Corrosion results: For Rinse Group
| Irritation parameter | Basis | Time point | Max.score | Reversibility | Remarks | |
| Overall irritation score | mean | 1 hour | 3.0 | 3.0 | not fully reversible within:35 days | Rinse |
| Cornea score | mean: all animals with grade 0 | 1 hour | 0 | 0 | not fully reversible within:35 days | Rinse |
| Iris score | 1 hour, 1,2,3,4,7,14,21,28 and 35 days | 0 | 0 | No iridal response was observed. | Rinse | |
| Conjunctival redness score | mean: all animals with grade 1 | 1 hour, 1,2,3,4 and 7 days | 1 | 1 | fully reversible within:14 days | Rinse |
| Conjunctival chemosis score | mean | 1 hour and day 1 | 2 | 2 | fully reversible within: day 2 | Rinse |
| Overall irritation score | mean | day 1 | 3.67 | 3.67 | not fully reversible within:35 days | Rinse |
| Cornea score | mean: Two animals with grade 1 and one with grade 0 | day 1,2,3,4 | >0 -<1 | 1 | not fully reversible within:35 days | Rinse |
| Overall irritation score | mean | days 2,3,4 | 1.67 | 1.67 | not fully reversible within:35 days | Rinse |
| Conjunctival chemosis score | mean: all animals with grade 0 | days 2,3,4,7,14,21,28 and 35 days | 0 | 0 | fully reversible within:2 days | Rinse |
| Overall irritation score | mean | day 7 | 1.33 | 1.33 | not fully reversible within:35 days | Rinse |
| Cornea score | mean:one animal with grade 1 and two eith grade 0 | day 7, 14 | >0 - <1 | 1 | not fully reversible within:35 days | Rinse |
| Conjunctival redness score | mean:all animals with grade 0 | day 14,21,28 and 35 | 0 | 0 | fully reversible within:14 days | Rinse |
| Overall irritation score | mean | day 14, 21,28 and 35 | 0.33 | 0.33 | not fully reversible within:35 days | Rinse |
| Cornea score | mean:one animals with grade 1 and two with grade 0 | day 14, 21, 28 and 35 | >0 - <1 | 1 | not fully reversible within:35 days | Rinse |
GHS Classification:
| Animal # | GHS Classification | What it means? | Cornea | Iris | Conjunctival redness | Conjunctival chemosis | Days to clear by individual animal |
| No rinse (Group I) | |||||||
| 1 | 1 | Irreversible eye irritation | 1.0 | 0 | 1.0 | 2.0 | Cornea not reversible by 35 days |
| 2 | 1 | Irreversible eye irritation | 1.0 | 0 | 1.0 | 1.33 | Cornea not reveersible by 35 days |
| 3 | 1 | Irreversible eye irritation | 1.0 | 0 | 1.0 | 1.33 | Cornea not reversible by 35 days |
| Rinse (Group II) | |||||||
| 1 | 1 | Irreversible eye irritation | 0.0 | 0 | 1.0 | 0.67 | Fully reversible within 14 days |
| 2 | 1 | Irreversible eye irritation | 1.0 | 0 | 1.0 | 0.67 | Fully reveersible within 14 days |
| 3 | 1 | Irreversible eye irritation | 1.0 | 0 | 1.0 | 0.67 | Cornea not fully reversible by 35 days |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- P0434 (27.8% Dodecyl dimethyl amine oxide) causes irreversible irritation to the rabbit eye.
- Executive summary:
The eyes of two groups of 3 rabbits were instilled with 0.1 ml of undiluted P0434 (27.8% DDAO). The eyes of the first group of 3 rabbits were not rinsed and the eyes of the second group of 3 rabbits were rinsed, approximately 4 seconds following instillation of the test material, with 20 ml of lukewarm distilled water.
Group I: The maximum average score was 4.0 at 1day. The observable response included irreversible corneal opacity in all three animals till 35 days, no iridic response was observed, conjunctival redness with grade 1 was observed which was fully reversed within 14 days and conjunctival chemosis upto grade 2 was observed which was fully reversed within 14 days.
Group II: The maximum average score was 3.67 at one day. The observable response included irreversible corneal opacity in one animal till 35 days, no iridic response was observed,conjunctival redness with grade 1 was observed which was fully reversed within 14 days and conjunctival chemosis up to grade 2 was observed which was fully reversed within 2 days.
From these observations it can be concluded that the test material P0434 (27.8% dodecyl dimethyl amine oxide) is causing irreversible irritation to the rabbit eye. Thus 27.8% DDAO can be classified as GHS category 1.
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