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EC number: 500-425-6 | CAS number: 159034-91-0 1 - 6.5 moles ethoxylated
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From December 24, 2001 to January 28, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- yes
- Remarks:
- animals not weighed at the end of the study
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- Propylidynetrimethanol, ethoxylated, esters with acrylic acid, reaction products with diethylamine
- EC Number:
- 500-425-6
- EC Name:
- Propylidynetrimethanol, ethoxylated, esters with acrylic acid, reaction products with diethylamine
- Cas Number:
- 159034-91-0
- Molecular formula:
- Not available for this UVCB
- IUPAC Name:
- Reaction product of poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-[(1-oxo-2-propenyl)oxy]-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1) and N-ethylethanamine
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 7-11 weeks
- Weight at study initiation: 1.45-2.03 kg
- Housing: Housed individually in labelled cages with perforated floors
- Diet: Standard laboratory rabbit diet (Charles River breeding and maintenance diet for rabbits, Altromin, Germany), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: Approximately 21 ± 3 °C
- Humidity: 30-70 %
- Air changes: Approximately 15 air changes/h
- Photoperiod: 12 h dark / 12 h artificial fluorescent light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: After 24 h observation, 2 % fluorescein in water was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage.
SCORING SYSTEM: Draize (1977) scoring system
TOOL USED TO ASSESS SCORE: Eye examination was performed using an ophthalmic examination lamp.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- - Corneal injury was seen as opacity (maximum grade 1) and epithelial damage (maximum 75% of the corneal area) leads to development of pannus (neovascularisation of the cornea) in one animal 7 days after instillation.
- Corneal injury had resolved within 7 days in two animals and within 14 days in the other animal.
- Iridial irritation (grade 1) was observed in all animals and had resolved within 72 h.
- Irritation of the conjunctivae was seen as redness, chemosis and discharge, which had completely resolved within 7 days in one animal and within 14 days in the other two animals.
- Reduced elasticity of the eyelids was noted in one animal 72 h after instillation.
- Remnants of the test substance were present on the outside of the eyelids of one animal on Days 1, 2 and 3. - Other effects:
- No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Table 1: Ocular reactions
Rabbit Number, sex & body weight |
Region of eye
|
Time after treatment |
||||||
1 h |
24 h |
48 h |
72 h |
7 days |
14 days |
|||
22 (male & 2031 g) Sentinel |
Cornea |
Opacity |
1 |
1 |
1 |
1 |
0 |
0 |
Area |
3 |
2 |
3 |
1 |
0 |
0 |
||
Fluor area (%) |
|
50 |
|
25 |
0 |
|
||
Iris |
0 |
1 |
1 |
0 |
0 |
0 |
||
Conjunctivae |
Redness |
2 |
2 |
3 |
3 |
1 |
0 |
|
Chemosis |
4 |
3 |
2 |
2 |
0 |
0 |
||
Discharge |
3 |
2 |
1 |
1 |
0 |
0 |
||
Comments |
c |
c |
c |
f |
- |
- |
||
107 (male & 1451 g) |
Cornea |
Opacity |
1 |
1 |
1 |
1 |
0 |
0 |
Area |
2 |
3 |
3 |
2 |
0 |
0 |
||
Fluor area (%) |
|
75 |
|
35 |
0 |
|
||
Iris |
0 |
1 |
1 |
0 |
0 |
0 |
||
Conjunctivae |
Redness |
2 |
3 |
3 |
2 |
0 |
0 |
|
Chemosis |
3 |
3 |
2 |
1 |
0 |
0 |
||
Discharge |
2 |
2 |
1 |
1 |
0 |
0 |
||
Comments |
- |
- |
- |
- |
- |
- |
||
109 (male & 1529 g) |
Cornea |
Opacity |
1 |
1 |
1 |
1 |
0 |
0 |
Area |
1 |
3 |
3 |
2 |
0 |
0 |
||
Fluor area (%) |
|
75 |
|
35 |
0 |
|
||
Iris |
0 |
1 |
1 |
0 |
0 |
0 |
||
Conjunctivae |
Redness |
2 |
3 |
3 |
2 |
1 |
0 |
|
Chemosis |
4 |
3 |
2 |
1 |
0 |
0 |
||
Discharge |
2 |
2 |
2 |
1 |
0 |
0 |
||
Comments |
- |
- |
- |
- |
p |
- |
||
Fluor area (%): green staining (percentage of total corneal area) after fluorescein treatment.
c - Remnants of the test substance on the outside of the eyelids.
f - Reduced elasticity of the eyelids.
p - Pannus (neovascularisation of the cornea)
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the test conditions, Diethylamine modified ethoxylated trimethylolpropane triacrylate is irritating to the eyes.
- Executive summary:
In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 3 healthy male rabbits of the New Zealand White strain were exposed to 0.1 mL of Diethylamine modified ethoxylated trimethylolpropane triacrylate in one eye, while the contralateral eye remained untreated and served as control. The study was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner 21 days later, after considering the degree of eye irritation observed in the first animal. The eyelids were then gently held together for about one second to prevent loss of the test material, and then released. The eyes were examined 1 and 24 h after instillation. After 24 h observation, 2% fluorescein in water was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. The eyes were also examined 48 and 72 h, 7 and 14 days after the treatment. Draize (1977) scoring system was followed to grade the ocular reactions.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. Corneal injury was seen as opacity (maximum grade 1) and epithelial damage (maximum 75% of the corneal area) leads to development of pannus (neovascularisation of the cornea) in one animal 7 days after instillation. Corneal injury had resolved within 7 days in two animals and within 14 days in the other animal. Iridial irritation (grade 1) was observed in all animals and had resolved within 72 h. Irritation of the conjunctivae was seen as redness, chemosis and discharge, which had completely resolved within 7 days in one animal and within 14 days in the other two animals. Reduced elasticity of the eyelids was noted in one animal 72 h after instillation. Remnants of the test substance were present on the outside of the eyelids of one animal on Days 1, 2 and 3. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 1, 1, 1 for cornea score; 0.7, 0.7, 0.7 for iris score; 2.7, 2.7, 2.7 for conjunctivae score and 2.3, 2, 2 for chemosis score. In this study, Diethylamine modified ethoxylated trimethylolpropane triacrylate (ACTILANE 715) is an eye irritant on male rabbits.
Under the test conditions, Diethylamine modified ethoxylated trimethylolpropane triacrylate is Irritating to eyes.
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