Registration Dossier
Registration Dossier
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EC number: 931-291-0 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January - February 23, 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Conducted in accordance with OECD TG 405 and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Group of constituents (alkyl derivatives) in Reaction products of 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-(C7-C17 odd-numbered, C17-unsatd. alkyl) derivs. and sodium hydroxide and chloroacetic acid
- Molecular formula:
- For two representative potential structures: C20H36N2O6Na2 : 446 and C18H35N2O4Na: 367
- IUPAC Name:
- Group of constituents (alkyl derivatives) in Reaction products of 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-(C7-C17 odd-numbered, C17-unsatd. alkyl) derivs. and sodium hydroxide and chloroacetic acid
- Reference substance name:
- Sodium chloride
- EC Number:
- 231-598-3
- EC Name:
- Sodium chloride
- Cas Number:
- 7647-14-5
- Molecular formula:
- ClNa
- IUPAC Name:
- Sodium chloride
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Oxidane
- Test material form:
- other: Aqueous solution
- Details on test material:
- - Physical state: Aqueous solution (clear, yellowish, viscous liquid)
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: EA Prinzhorn, Altenbticken, Germany
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: individual housing in a battery of cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 15/1/1995 To: 7/2/1995
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated right eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): not applicable
VEHICLE
Not applicable - Duration of treatment / exposure:
- Not applicable (no washout)
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: Not applicable (no washout)
SCORING SYSTEM: as stipulated by OECD 405
TOOL USED TO ASSESS SCORE: no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: Mean for animals #1, #2 and #3
- Time point:
- other: Mean value of score at 24, 48 and 72 h after installation
- Score:
- 1.44
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days (in animal #2)
- Remarks on result:
- other: Individual mean scores: 2 - 1.67 - 0.67
- Irritation parameter:
- iris score
- Basis:
- other: Mean for animals #1, #2 and #3
- Time point:
- other: Mean value of score at 24, 48 and 72 h after installation
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days (in all animals)
- Remarks on result:
- other: Individual mean scores: 0.67 - 1 - 0.33
- Irritation parameter:
- conjunctivae score
- Basis:
- other: Mean for animals #1, #2 and #3
- Time point:
- other: Mean value of score at 24, 48 and 72 h after installation
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days (in animal #2)
- Remarks on result:
- other: Individual mean scores: 3 - 3 - 3
- Irritation parameter:
- chemosis score
- Basis:
- other: Mean for animals #1, #2 and #3
- Time point:
- other: Mean value of score at 24, 48 and 72 h after installation
- Score:
- 2.44
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days (in animal #2)
- Remarks on result:
- other: Individual mean scores: 3 - 2.33 - 2
Any other information on results incl. tables
|
Scores for corneal opacity |
|||
CORNEA |
24h |
48h |
72h |
Individual mean scores |
Rabbit 1 |
2 |
2 |
2 |
2 |
Rabbit 2 |
1 |
2 |
2 |
1.67 |
Rabbit 3 |
1 |
1 |
0 |
0.67 |
|
Scores for iris lesion |
|||
IRIS |
24h |
48h |
72h |
Individual mean scores |
Rabbit 1 |
1 |
1 |
0 |
0.67 |
Rabbit 2 |
1 |
1 |
1 |
1.0 |
Rabbit 3 |
1 |
0 |
0 |
0.33 |
|
Scores for Redness and Chemosis of conjunctivae |
|||
CONJUNCTIVAE |
24h |
48h |
72h |
Individual mean scores |
Redness |
Redness |
Redness |
Redness |
|
Chemosis |
Chemosis |
Chemosis |
Chemosis |
|
Rabbit 1 |
3 |
3 |
3 |
3.0 |
3 |
3 |
3 |
3.0 |
|
Rabbit 2 |
3 |
3 |
3 |
3.0 |
3 |
2 |
2 |
2.33 |
|
Rabbit 3 |
3 |
3 |
3 |
3.0 |
2 |
2 |
2 |
2.0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Conclusions:
- As the effects in animal #2 on the cornea and conjunctiva did not fully reversed within the observation period of 21 days, the substance has the potential to seriously damage the eyes and is classified in Category 1 (irreversible effects on the eye).
- Executive summary:
The potential toxicity of the substance was assessed in an acute eye irritation/corrosion test on 3 albino rabbits. In each animal, 0.1 mL of the test article was introduced into the conjunctival sac of one eye, the untreated eye served as control. Both eyes were examined at 1, 24, 48 and 72 h post application and thereafter once daily up to day 8 p.a. in 2 animals (no. 1 and no. 3) and up to day 21 p.a. in one animal (no. 2). Slight to moderate corneal opacity, hyperemia of the iris, moderate to severe redness and swelling of the conjunctivae as well as moderate secretion was observed in all animals. Additionally, bloody infiltration of the nictitating membrane was seen in one animal. As these findings were not fully reversible within 21 days p.a. in one animal (no. 2), the substance has the potential to seriously damage the eyes and is classified in Category 1 (irreversible effects on the eye).
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