Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 Sept 1997 - 26 Sept 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD) (test substance purity not specified).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted Feb 1987
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
adopted 29 Dec 1992
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): Epicol G24 G2, C12/14alpha-Epoxid, ringgeöffnet mit Glykol, SAT970397
- Physical state: colorless, transparent fluid
- Analytical purity: not specified
- Lot/batch No.: 10017020
- Expiration date of the lot/batch: 20.01.1998
- Storage condition of test material: room temperature in the darkness

Test animals / tissue source

Species:
rabbit
Strain:
other: SPF albino, Mol:Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Mollegaard Breeding and Research Center A/S, Lille Skensved
- Weight at study initiation: 2.4 - 2.5 kg
- Diet: pelleted complete rabbit diet, Altromin 2123, ad libitum
- Water: domestic quality drinking water, acidified with hydrochloric acid to pH 2.5 to prevent microbial growth, ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
reading time points at 1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
onr single animal followed by two further animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with 20 mL 0.9 % sodium chloride after instillation of fluorescein
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize Scoring System

TOOL USED TO ASSESS SCORE: fluorescein & UV-light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1 - #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal#1 - #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1 - #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1 - #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
One hour after application if the test article all animals showed slight redness of conjunctivae. One animal additionally showed slight swelling of the conjunctivae. After 24 and 48 hours all animals showed slight redness of conjunctivae and only a slight swelling of conjunctivae was still visible. After 72 hours no eye reactions could be observed any more.
Other effects:
Discharge with moistening of lids and hairs, and considerable area around the eye was observed in the animal with swelling of the conjunctivae. Discharge with moistening of lids and hairs just adjacent to lids was observed in one of the other two animals, whereas the third animal only showed slight discharge.

Any other information on results incl. tables

Table1: Overview of individual scores

   Cornea  Iris   Conjunctiva      
   opacity    Redness  Chemosis
 1 h (animal 1)  0  0  1  1
 24 h  0  0  1  1
 48 h  0  0  1  0
 72 h  0  0  0  0
 mean score (24 - 72 h)  0  0  0.67  0.33
 1 h (animal 2)  0  0  1  0
 24 h  0  0  1  1
 48 h  0  0  1  0
 72 h  0  0  0  0
 mean score (24 - 72 h)  0  0  0.67  0.33
 1 h (animal 3)  0  0  1  0
 24 h  0  0  1  0
 48 h  0  0  1  0
 72 h  0  0  0  0
 mean score (24 - 72 h)  0  0  0.67  0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DSD: not classified
CLP: not classified