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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1 - 5 December 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

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 (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Product name: Amgard V6
Appearance: very pale straw coloured viscous liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.47 - 2.73 kg
- Housing: suspended metal cages
- Diet: ad libitum (STANRAB SQC)
- Water: ad libitum
- Acclimation period: minimum 5 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21
- Humidity (%): 50 - 59
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Left eye of each rabbit remained untreated and was used for control purposes
Amount / concentration applied:
0.1 mL of test material
Observation period (in vivo):
1 hour and 24, 48 and 72 hours following treatment.
Number of animals or in vitro replicates:
One rabbit was initially treated. After consideration of the ocular responses, two additional animals were treated.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not performed


SCORING SYSTEM: Draize Scale and modified Kay and Clandria Scheme. Additional according to 91/325/EEC.


TOOL USED TO ASSESS SCORE: standard ophthalmoscope with light source.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Reversibility:
fully reversible within: 48H
Remarks on result:
other: Data from study Cuthbert JA Jackson D(1990). See supportive study attached
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Reversibility:
fully reversible within: 48H
Remarks on result:
other: Data from study Cuthbert JA Jackson D(1990). See supportive study attached
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Reversibility:
not fully reversible within: 48h
Remarks on result:
other: Data from study Cuthbert JA Jackson D(1990). See supportive study attached
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 Hour after treatment
Score:
1
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 Hour after treatment
Score:
1
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 1 hour after treatment
Score:
1
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0 - 0
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Reversibility:
not specified
Irritant / corrosive response data:
- Minimal conjunctival redness (score 1) was noted in all treated animals 1 hour after treatment
- All treated eyes appeared normal after 24, 48 and 72 hours after treatment
- No conreal or iridial effects were noted during the study
- Maximum group mean score was 2.0; leading to classification as Non-irritating (class 1 on a scale from 1 to 8, according to modified Kay and Calandra classification system)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was not irritant to rabbit eye under the conditions of this study.
Executive summary:

In a primary eye irritation study, according to OECD Guideline No.405, 0.1 mL of undiluted 2,2-bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate) was instilled into the conjunctival sac of 3 New Zealand white rabbits (1 female, 2 male rabbits used). Animals then were observed for 3 days. Irritation was scored by the method of Draize, scale for scoring ocular irritation. The test material was not irritant to rabbit eye under the conditions of this study.