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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: according to guideline, limited documentation, non-GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted May 12th, 1981
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dihydrorosenoxyd
no further data provided

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler; 6050 Offenbach/Main, Germany
- Weight at study initiation: 3.31 kg, 2.95 kg, 2.80 kg
- Housing: single
- Diet: 130 g per animal per day (Ovator Solikanin 4mm)
- Water: daily 250 mL
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
1, 24, 48, 72 hours and 8 days
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 1-3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 1-3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 1-3
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 1-3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable

Any other information on results incl. tables

Cornea   Iris Conjunctiva      
Readings Animal Opacity Area involved   Redness Swelling Discharge Further findings
1h 1 0 0 0 2 1 1  
  2 0 0 0 2 1 1  
  3 0 0 0 2 1 1  
24h 1 0 0 0 1 0 0  
  2 0 0 0 1 0 0  
  3 0 0 0 1 0 0  
48h 1 0 0 0 1 0 0  
  2 0 0 0 1 0 0  
  3 0 0 0 1 0 0  
72h 1 0 0 0 1 0 0  
  2 0 0 0 1 0 0  
  3 0 0 0 1 0 0  
8d 1 0 0 0 0 0 0  
  2 0 0 0 0 0 0  
  3 0 0 0 0 0 0  
Mean (24h-72h) 1 0,0 0,0 0,0 1,0 0,0 0,0  
  2 0,0 0,0 0,0 1,0 0,0 0,0  
  3 0,0 0,0 0,0 1,0 0,0 0,0  
Mean (24h-72h) all animals 0,0 0,0 0,0 1,0 0,0 0,0  

Applicant's summary and conclusion