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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium diformate
EC Number:
208-863-7
EC Name:
Calcium diformate
Cas Number:
544-17-2
Molecular formula:
CH2O2.1/2Ca
IUPAC Name:
calcium diformate
Details on test material:
- Name of test material (as cited in study report): Calciumformiat technisch
- Substance type: salt
- Physical state: solid
- Analytical purity: 99.8%
- Purity test date: 1999-Jul-06
- Lot/batch No.: H0509

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology KG, Löhndorf, Germany
- Age at study initiation: 4-8.5 months
- Weight at study initiation: 2.2 - 2.3 kg
- Housing: singly in cages with special restrainers to avoid possibility of skin irritation by excrements or urine
- Diet: standard diet ALTROMIN 2023 ad libitum
- Water: tap water ad libitum
- Acclimatisation: at least 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 50+/-20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 mg
Duration of treatment / exposure:
single dose
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no data


SCORING SYSTEM: according to Draize, cf. table contained in OECD 405


TOOL USED TO ASSESS SCORE: hand-slit lamp (at 1, 24, 48, and 72 hours)/ fluorescein (at 24 hours and 7 days)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hours
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hours
Score:
2
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 hours
Score:
2
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hours
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hours
Score:
2
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 hours
Score:
1.67
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days

Any other information on results incl. tables

Table: eye irritation results (scores of animals 1/2/3)

 

 

Time post administration

(hours)

CORNEA

IRIS

CONJUNCTIVAE

Corneal area affected

(%)

 

Opacity

 

Redness

Chemosis

 

24

2/2/2

2/2/2

2/2/2

2/2/2

50%

(animals

No. 1 and 3)

48

2/2/2

2/2/2

2/2/2

2/2/1

 

72

1/1/1

1/1/1

2/2/1

1/1/0

75% animal No. 2

 

 

 

 

 

 

7 days

 

 

 

 

no pathological finding

 

All reactions were reversible within the 14 day observation period. Corneal opacity and iritis were absent on day 7.

Conjunctival effects persisted until day 13. Induration of the lower lid was seen in a all animals on days 3 through 13 after treatment.

 

 

 

Applicant's summary and conclusion

Conclusions:
Calcium diformate caused reversible irritating to the rabbit's eyes. Results require labeling R41: risk of serious eye damage.
Classification: risk of serious damage to eyes.
Executive summary:

The eye irritating properties of calcium diformate (100 mg) was examined in rabbits (Himalayan, 3 males) according to OECD guideline No. 405 and under GLP conditions. Marked corneal opacity (mean score 2.0), severe iritis (mean score 2.0), and marked conjunctival reactions (mean scores redness and chemosis 2.0) were seen during days 1 to 3. All reactions were reversible within the 14 day observation period. Corneal opacity and iritis were absent on day 7, conjunctival effects on day 14. Induration of the lower lid was seen in all animals on days 3 through 13 after treatment.

 

Overall, calcium diformate was irritating to the rabbit's eyes. Results require labeling (R41: risk of serious eye damage) and classification (risk of serious damage to eyes) (LPT, 1999). The study is considered to be valid and acceptable for assessment.