Registration Dossier

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:
26-01-2015 to 09-03-2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study according to the guidelines under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
Identification: Fats and Glyceridic oils, vegetable, winterized, reaction products with ammonia-ethanolamine reaction products
Physical state / Appearance: brown extremely viscous liquid
Storage Conditions: room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Strain: New Zealand White (Hsdlf:NZW)
- Age at study initiation: 12 and 20 weeks
- Weight at study initiation: 2.6 and 3.1 kg
- Housing: individually
- Water: ad libitum
- Feed: 2930C Teklad Global Rabbit diet ad libitum
- Acclimation period: ≥ 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70%
- Air changes (per hr): ≥ 15/hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL: 0.1 mL
Observation period (in vivo):
Animal 1 21 days, Animal 2 14 days
Scoring at 1, 24, 46 and 72 h and 7, 14 and 21 days after instillation
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: Draize with calculations of irritation score according to modified version of the system described by Kay J.H. and Calandra J.C. (1962))

TOOL USED TO ASSESS SCORE: light of ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 1 - <= 2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Other effects:
Body weight gain within normal ranges
No othetr signs of toxicity or pain

Any other information on results incl. tables

Animal no

1

2

1

24

48

72

7

14

21

1

24

48

72

7

14

cornea

1

1

1

1

1

1

0

0

0

0

0

0

0

iris

1

1

1

1

1

0

0

1

1

1

1

0

0

conjunctivae

 

 

 

 

 

 

 

 

 

 

 

 

 

redness

2

2

2

2

2

1

0

2

2

2

2

1

0

chemosis

3

3

3

3

1

0

0

2

2

2

2

1

0

discharge

3

3

3

3

2

1

0

3

2

1

1

0

0

 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The substance is irritating to the eyes
Executive summary:

The substance was installed in the eye of 2 rabbits (subsequently treated). The results are indicative for the classification as irritating to the eyes (category 2).