Calcium diformate

Eye irritation

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

Test material information

Constituent 1

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 h

Score:

2

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 48 hours

Score:

2

Max. score:

4

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 hours

Score:

2

Max. score:

2

Results 5

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 48 hours

Score:

2

Max. score:

2

Results 6

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 72 hours

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 hours

Score:

2

Max. score:

3

Results 8

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 48 hours

Score:

2

Max. score:

3

Results 9

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 72 hours

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 10

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 hours

Score:

2

Max. score:

4

Results 11

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 48 hours

Score:

1.67

Max. score:

4

Results 12

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 72 hours

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 13

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 14

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 15

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 16

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

48 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 17

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

48 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 18

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

48 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 19

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 20

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 21

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 22

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 23

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 24

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 25

Irritation parameter:

iris score

Basis:

animal #1

Time point:

48 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 26

Irritation parameter:

iris score

Basis:

animal #2

Time point:

48 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 27

Irritation parameter:

iris score

Basis:

animal #3

Time point:

48 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 28

Irritation parameter:

iris score

Basis:

animal #1

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 29

Irritation parameter:

iris score

Basis:

animal #2

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 30

Irritation parameter:

iris score

Basis:

animal #3

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 31

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 32

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 33

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 34

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

48 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 35

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

48 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 36

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

48 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 37

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 38

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 39

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 40

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 41

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 42

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 43

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

48 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 44

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

48 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 45

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 46

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 47

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 48

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.