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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:
Study performed between 2 May 2005 to 12 May 2005.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed to GLP and internationally accepted guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Bentonite, acid-leached
EC Number:
274-324-8
EC Name:
Bentonite, acid-leached
Cas Number:
70131-50-9
Molecular formula:
unspecified for this UVCB substance
IUPAC Name:
Bentonite, acid-leached
Details on test material:
Name of test material (as cited in study report): Acid-activated bentonite
Physical state: pale beige powder
Batch No.: Tonsil EX 0096.
Chemical composition: SiO2 (66.8%), Al2O3 (14.2%), Fe2O3 (3.7%), MgO (2.3%), CaO (1.1%), Na2O (0.8%), K2O (2.2%), LOI (8.0%).
Storage condition of test material: room temperature in the dark
Moisture content: approx. 10%.
Particle size: 5 % > 150 µm; 17% > 100 µm; 29% > 63 µm; 40% > 45 µm; 60% > 25 µm.
pH (10% suspension): approximately 3.8.

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, Sandbach, Cheshire, UK
Age at study initiation: 12-20 weeks old.
Weight at study initiation: 2.0-3.5 Kgs.
Housing: housed in suspended cages.
Diet: ad libitum
Water: ad libitum
Acclimation period: five days

Environmental conditions
Temperature (°C): 17-23 °C
Humidity (%): 30-70%
Air changes (per hr): fifteen changes per hour
Photoperiod (hrs dark / hrs light): twelve hours continuous light / twelve hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye remained untreated and was used for control purposes.
Amount / concentration applied:
Test material:
Amount applied: 0.1 mL of test material which was found to weigh approximately 52 mg.
Duration of treatment / exposure:
one second
Observation period (in vivo):
1, 24, 48 and 72 hours.
Number of animals or in vitro replicates:
3
Details on study design:
Scoring system: Kay and Calandra classification system.

Tool used to assess score: use of light source from a standard ophthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: mean score for all animals
Time point:
other: 24, 48 72 h
Score:
0
Remarks on result:
other: according to criteria set out in CLP Regulation (EC) no. 1272/2008
Irritation parameter:
iris score
Basis:
other: mean score for all animals
Time point:
other: 24, 48, 72 h
Score:
0
Remarks on result:
other: according to criteria set out in CLP Regulation (EC) no. 1272/2008
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
mean score for all animals
Time point:
other: 24, 48, 72 h
Score:
0.67
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: according to criteria set out in CLP Regulation (EC) no. 1272/2008
Irritation parameter:
chemosis score
Basis:
other: mean score for animal #16
Time point:
other: 24, 48, 72h
Score:
0.33
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: according to criteria set out in CLP Regulation (EC) no. 1272/2008
Irritation parameter:
chemosis score
Basis:
other: mean score for animal #22 and #23
Time point:
other: 24, 48, 72 h
Score:
0
Irritant / corrosive response data:
Beige-coloured residual test material was noted in all treated eyes one hour after treatment. No corneal effects were noted during the study. Iridial inflammation was noted in all treated eyes one hour after treatment.
Minimal conjunctival irritation was noted in all treated eyes one hour after treatment and at the 24 and 48-hour observations. All treated eyes appeared normal at the 72-hour observation.
Individual scores are provided in table 1.






Any other information on results incl. tables

Table 1: Individual scores and individual total scores for ocular irriation

Rabbit number and sex

 

16 male

22 male

23 male

IPR = 2

IPR = 2

IPR = 3

Time after treatment

1 h

24 h

48 h

72 h

1 h

24 h

48 h

72 h

1 h

24 h

48 h

72 h

CORNEA

 

 

 

 

 

 

 

 

 

 

 

 

E = degree of opacity

0

0

0

0

0

0

0

0

0

0

0

0

F = area of cornea involved

0

0

0

0

0

0

0

0

0

0

0

0

Score (E x F) x 5

0

0

0

0

0

0

0

0

0

0

0

0

IRIS

 

 

 

 

 

 

 

 

 

 

 

 

D

1

0

0

0

1

0

0

0

1

0

0

0

Score (D x 5)

5

0

0

0

5

0

0

0

5

0

0

0

CONJUNCTIVAE

 

 

 

 

 

 

 

 

 

 

 

 

A = redness

1

1

1

0

1

1

1

0

1

1

1

0

B = chemosis

1

1

0

0

1

0

0

0

1

0

0

0

C = discharge

1 Re

1

0

0

1 Re

1

0

0

1Re

1

0

0

Score (A + B + C) x 2

6

6

2

0

6

4

2

0

6

4

2

0

Total score

11

6

2

0

11

4

2

0

11

4

2

0

IPR = Initial pain reaction

Re - Beige-coloured residual test material noted in the treated eye.

Table 2. Individual Total Scores and group Mean Scores for Ocular Irritation.

Rabbit Number and Sex

Individual Total Scores at:

1 hour

24 hours

48 hours

72 hours

Male 16

11

6

2

0

Male 22

11

4

2

0

Male 23

11

4

2

0

Group Total

33

14

6

0

Group Mean Score

11.0

4.7

2.0

0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Acid-activated bentonite is not irritating to eyes according to the criteria set out in CLP Regulation (EC) no. 1272/2008

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