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EC number: 606-826-3 | CAS number: 217308-07-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Benzeneacetic acid, .alpha.-hydroxy-, monoammonium salt, (.alpha.R)- (dried)
- IUPAC Name:
- Benzeneacetic acid, .alpha.-hydroxy-, monoammonium salt, (.alpha.R)- (dried)
- Reference substance name:
- Benzeneacetic acid, .alpha.-hydroxy-, monoammonium salt, (.alpha.R)-
- EC Number:
- 606-826-3
- Cas Number:
- 217308-07-1
- Molecular formula:
- C8 H8 O3 .H3 N
- IUPAC Name:
- Benzeneacetic acid, .alpha.-hydroxy-, monoammonium salt, (.alpha.R)-
- Details on test material:
- - Name of test material (as cited in study report):Benzeneacetic acid, .alpha.-hydroxy-, monoammonium salt, (.alpha.R)- (dried)
- Physical state: Solid / brown (paste-like)
- Analytical purity: w (C8H7O3): 84.5 g/100 g
- Lot/batch No.: 128/2015
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: Envigo CRS (Switzerland) Limited
- Age at study initiation: approx. 3 months
- Weight at study initiation: 2.18 kg – 2.35 kg
- Housing: single
- Diet (e.g. ad libitum): STANRAB (P) SQC; SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days before application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 30 - 70 %
- Air changes (per hr): Approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- other: deionized water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Form of application: 80% (w/v) solution in de-ionized water (saturated solution)
Due to the physical state (highly viscous paste) the test item was not applicable in the usual dosage form as a solid. Therefore the test item was solved at the technical highest concentration of 80% (w/w) in deionized water. - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 3 (female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: about 24 hours after application of the test item the treated eye of the animal(s) was rinsed with 3 to 6 mL of lukewarm tap water for 1 to 2 minutes using a syringe with a blunt probe
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
Any other information on results incl. tables
Tabulation of irritant response, data for each individual animal at each observation time as well as calculation of the means.
|
Cornea |
Iris |
Conjuncitva |
||||
Readings |
Animal No. |
Opacity |
Area of cornea involved |
Redness |
Chemosis |
Discharge |
|
1 h |
1 |
0 |
0 |
0 |
1 |
2 |
3 |
2 |
0 |
0 |
0 |
1 |
1 |
2 |
|
3 |
0 |
0 |
0 |
2 |
2 |
1 |
|
24 h |
1 |
1 |
4 |
1 |
2 |
2 |
1 |
2 |
0 |
0 |
0 |
1 |
1 |
1 |
|
3 |
0 |
0 |
0 |
2 |
2 |
1 |
|
48 h |
1 |
1 |
2 |
0 |
2 |
1 |
0 |
2 |
0 |
0 |
0 |
1 |
1 |
0 |
|
3 |
0 |
0 |
0 |
2 |
2 |
0 |
|
72 h |
1 |
1 |
1 |
0 |
2 |
1 |
0 |
2 |
0 |
0 |
0 |
1 |
1 |
0 |
|
3 |
0 |
0 |
0 |
2 |
1 |
0 |
|
7 d |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean 24 h – 72 h |
1 |
1.0 |
- |
0.3 |
2.0 |
1.3 |
- |
2 |
0.0 |
- |
0.0 |
1.0 |
1.0 |
- |
|
3 |
0.0 |
- |
0.0 |
2.0 |
1.7 |
- |
|
Mean |
|
0.3 |
- |
0.1 |
1.7 |
1.3 |
- |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information
- Conclusions:
- Considering the described ocular reactions as well as the average score for irritation, Benzeneacetic acid, .alpha.-hydroxy-, monoammonium salt, (.alpha.R)- (dried) shows an eye irritating potential under the test conditions chosen.
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