Registration Dossier

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: according to OECD guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Nerylacetat
- Lot/batch No.: 50547891
- Physical state: colourless liquid
- Analytical purity: 94.2 %
- Storage condition of test material: cool and dry

Test animals / tissue source

Species:
rabbit
Strain:
other: SPF albino - Chbb:HM(SPF) Littlerussian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: BI Pharma KG, 88397 Biberach
- Weight at study initiation: 2.5 - 2.9 kg
- Housing: individually in PPO cages with perforated floor
- Diet (e.g. ad libitum): pelleted complete rabbit diet "Altromin 2123" was available, ad libitum
- Water (e.g. ad libitum): domestic quality drinking water acidified with hydrochloric acid to pH 2.5, ad libitum
- Acclimation period: at least 1 w


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 40 - 60
- Air changes (per hr): 10x
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
single treatment (washed out after 24h)
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
4
Details on study design:
SCORING SYSTEM:
according to OECD guideline
TOOL USED TO ASSESS SCORE: fluorescein after 24 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 1-4
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 1-4
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 1-4
Time point:
other: 24, 48, 72 h
Score:
0.4
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 1-4
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72h

Any other information on results incl. tables

Cornea Iris Conjunctiva  
Readings Animal Opacity   Redness Swelling
1h 1 0 1 1 1
  2 0 0 1 0
  3 0 0 1 1
  4 0 0 1 1
24h 1 0 0 1 0
  2 0 0 1 1
  3 0 0 1 1
  4 0 0 1 1
48h 1 0 0 0 0
  2 0 0 0 0
  3 0 0 0 0
  4 0 0 1 1
72d 1 0 0 0 0
  2 0 0 0 0
  3 0 0 0 0
  4 0 0 0 0
Mean (24h-72h) 1 0,0 0,0 0,3 0,0
  2 0,0 0,0 0,3 0,3
  3 0,0 0,0 0,3 0,3
  4 0,0 0,0 0,7 0,7
Mean (24h-72h) all animals 0,0 0,0 0,4 0,3

Applicant's summary and conclusion