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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:
14 June 2004 to 24 June 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium carbonate
EC Number:
207-439-9
EC Name:
Calcium carbonate
Cas Number:
471-34-1
Molecular formula:
CH2O3.Ca
IUPAC Name:
calcium carbonate
Test material form:
other: bulk
Details on test material:
Supplier: Solvay S.A
Trade name: PCC
Description: White powder
Batch number: ANMM001172

Mineral composition:
Calcium carbonate: > 98.5%
Impurities: Mg, Fe, Al, SO4, Cl

Other information:
Mean particle size: 0.2 - 2.0 µm
pH (10% suspension): 9.7 - 9.9
Specific gravimetry: 2.71

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: David Percival Ltd, Moston, Sandbach, Cheshire UK.
- Weight: 2.0 to 3.5 kg
- Age: 12 - 20 weeks old.
- Acclimation period: at least 5 days
- Housing: the animals were individually housed in suspended metal cages
Free access to mains drinking water and food (Certified Rabbit Diet code 5322) allowed throughout the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70%
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Left eye served as control
Amount / concentration applied:
0.1 mL of the test material (~61 mg)
Duration of treatment / exposure:
Animals were exposed to the test material for up to 72 hours.
Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3 male animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
Not specified


SCORING SYSTEM: Assessment of ocular damage/ irritation was made according to Draize. Ocular irritancy potential of the test material was determined using a modified version of the system described by Kay and Calandra.


TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Mean scores calculated according to the criteria described in Regulation (EC) No 1272/2008
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other: Mean scores calculated according to the criteria described in Regulation (EC) No 1272/2008
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Mean scores calculated according to the criteria described in Regulation (EC) No 1272/2008
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Mean scores calculated according to the criteria described in Regulation (EC) No 1272/2008
Irritant / corrosive response data:
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.
Other effects:
The initial pain reaction was grade 2 (rabbit blinks and tries to open eye but reflex closes it, slight initial pain).

Any other information on results incl. tables

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

Rabbit number and sex

83 Male

(IPR = 2)

26 Male

(IPR = 2)

27 Male

(IPR = 2)

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

F=area of cornea involved

 

0

 

0

 

0

 

0

 

0

 

0

 

0

 

0

 

0

 

0

 

0

 

0

 

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

CONJUNCTIVAE

A=Redness

B=Chemosis

C=Discharge

 

1

1

1

 

1

0

1

 

1

0

0

 

0

0

0

 

1

1

1

 

1

0

1

 

1

0

0

 

0

0

0

 

1

1

1

 

1

0

1

 

1

0

0

 

0

0

0

IPR = Initial Pain Reaction

Table 2: Mean Scores for Ocular Irritation

Skin Reaction

Mean scores for 24, 48 and 72 hours

 -

83 Male

26 Male

27 Male

Cornea

0

0

0

Iris

0

0

0

Conjunctivae - redness

2/3 = 0.67

2/3 = 0.67

2/3 = 0.67

Conjunctivae – chemosis

0

0

0

No corneal effects were noted during the study.

Iridial inflammation was noted in all treated eyes on 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.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
There were no corneal or iridial effects or chemosis noted during the study after 24 hours of exposure; hence, the mean scores for 24, 48 and 72 hours for each animal were 0. The mean scores for 24, 48 and 72 hours for each animal for conjunctivae redness, although above 0, were below the limits for classification as irritating to eyes (Category 2) and the effects were fully reversible within an observation period of 21 days. PCC is therefore non-irritating to eyes and does not require classification according to the criteria described in Regulation (EC) No 1272/2008.