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EC number: 701-440-2 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From January 24 to May 30, 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- individual animal weights not reported; 6 animals tested instead of 3
- GLP compliance:
- yes
Test material
- Reference substance name:
- Esterification products of acrylic acid with reaction products of 2,2-dimethylpropane-1,3-diol and methyloxirane
- EC Number:
- 701-440-2
- Molecular formula:
- (C3H6O)x (C3H6O)y C11H16O4
- IUPAC Name:
- Esterification products of acrylic acid with reaction products of 2,2-dimethylpropane-1,3-diol and methyloxirane
- 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: Froxfield (U.K.) Ltd., Petersfield, England
- Age at study initiation: Approximately 12-13 weeks
- Weight at study initiation: 2.8-3.0 kg
- Housing: Housed individually in plastic cages
- Diet: Standard laboratory diet (SDS Stanrab (P) Rabbit diet), ad libitum
- Water: Drinking water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: Approximately 19 °C
- Humidity: 30-70 %
- Air changes: Approximately 19 air changes/h
- Photoperiod: 12 h dark / 12 h artificial 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:
- No washing was done
- Observation period (in vivo):
- 7 days
- Examination of the eyes was made after 1 h and 1, 2, 3 (equivalent to 24, 48 and 72 h after instillation), 4 and 7 days after instillation. - Number of animals or in vitro replicates:
- 6 (1 male and 5 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: Draize (1977) scoring system
TOOL USED TO ASSESS SCORE: Observation of the eyes was aided by the use of a handheld light.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0.45
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Mean individual scores = 0,67 - 0 - 1 - 0 - 0 - 1
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0.06
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: Mean individual scores = 0 - 0.33 - 0 - 0 - 0 - 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 1.34
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Mean individual scores = 1,67 - 1,33 - 2 - 0,67 - 0,66 - 1,67
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 1.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Mean individual scores = 1 - 2 - 2 - 0,33- 0,33-1
- Irritant / corrosive response data:
- - Corneal opacities developed in 3 animals.
- Dulling of the normal lustre of the cornea alone was seen in 2 animals.
- Transient iridial inflammation was observed in 1 animal.
- A diffuse crimson red colouration of the conjunctivae was seen in all 6 animals and was accompanied in 4 by considerable swelling with partial eversion of the eyelids or with the eyelids about half closed.
- Eyes were normal by 3 or 7 days after instillation. - Other effects:
- No signs of toxicity were observed in any animal throughout the observation period.
Any other information on results incl. tables
Table 1: Ocular reactions observed after instillation of SR 9003
Rabbit number and sex
|
Region of eye
|
1 h |
Day after instillation |
|||||
1 |
2 |
3 |
4 |
7 |
||||
020 * (male) |
Cornea
|
0 |
0 |
1 |
1 |
1 |
0 |
|
Iris
|
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva
|
Redness
|
2 |
2 |
2 |
1 |
1 |
0 |
|
Chemosis
|
1 |
1 |
1 |
1 |
0 |
0 |
||
070 (Female) |
Cornea
|
D |
0 |
0 |
0 |
0 |
0 |
|
Iris
|
0 |
0 |
0 |
1 |
0 |
0 |
||
Conjunctiva
|
Redness
|
2 |
1 |
1 |
2 |
2 |
0 |
|
Chemosis
|
2 |
2 |
2 |
2 |
1 |
0 |
||
071 (Female) |
Cornea
|
D |
1 |
1 |
1 |
1 |
0 |
|
Iris
|
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva
|
Redness
|
2 |
2 |
2 |
2 |
2 |
0 |
|
Chemosis
|
2 |
2 |
2 |
2 |
1 |
0 |
||
553 (Female) |
Cornea
|
D |
0 |
0 |
0 |
0 |
0 |
|
Iris
|
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva
|
Redness
|
2 |
1 |
1 |
0 |
0 |
0 |
|
Chemosis
|
2 |
1 |
0 |
0 |
0 |
0 |
||
554 (Female) |
Cornea
|
D |
0 |
0 |
0 |
0 |
0 |
|
Iris
|
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva
|
Redness
|
2 |
1 |
1 |
0 |
0 |
0 |
|
Chemosis
|
3 |
1 |
0 |
0 |
0 |
0 |
||
555 (Female) |
Cornea
|
D |
1 |
1 |
1 |
1 |
0 |
|
Iris
|
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva
|
Redness
|
2 |
2 |
2 |
1 |
1 |
0 |
|
Chemosis
|
1 |
1 |
1 |
1 |
0 |
0 |
||
* Pilot animal
D - Dulling
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not eye irritating.
- Conclusions:
- Under the test conditions, Propoxylated neopentylglycol diacrylate is not classified as irritating to eyes.
- Executive summary:
In an eye irritation study conducted similarly to the OECD Guideline 405 and in compliance with GLP, 6 healthy rabbits (1 male and 5 females) of the New Zealand White strain were exposed to 0.1 mL of Propoxylated neopentylglycol diacrylate in one eye, while the contralateral eye remained untreated and served as control. The eyelids were then gently held together for one second before releasing. The eyes were examined unwashed and the changes were observed at 1 h and 1, 2, 3 (equivalent to 24, 48 and 72 h), 4 and 7 days after instillation and graded according to the method of Draize (1977).
Corneal opacification, iridial inflammation and well-defined conjunctival reactions were observed. All reactions had resolved in 3 or 7 days after instillation. Mean individual scores at 24, 48 and 72 h after exposure for the 6 animals were respectively 0.67, 0.00, 1.00, 0.00, 0.00, 1.00 for cornea score; 0.00, 0.33, 0.00, 0.00, 0.00, 0.00 for iris score; 1.67, 1.33, 2.00, 0.67, 0.67, 1.67 for conjunctivae score and 1.00, 2.00, 2.00, 0.33, 0.33, 1.00 for chemosis score. In this study, Propoxylated neopentylglycol diacrylate is not an eye irritant on rabbits.
Under the test conditions, Propoxylated neopentylglycol diacrylate is not classified as irritating to eyes.
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