Strontium peroxide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Strontium oxalate

EC Number:

212-415-6

EC Name:

Strontium oxalate

Cas Number:

814-95-9

Molecular formula:

C2H2O4.Sr

IUPAC Name:

strontium oxalate

Test material form:

solid: particulate/powder

Details on test material:

The following starting products was used : H2C204'2H20
The compound was a fine, white powder. The amount of hydration water was checked by TGA.

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and batch No.of test material: Bernardy, batch No 1702507
- Expiration date of the lot/batch: 13 January 2022
- Production date: 13 January 2017
- Purity test date: 14 January 2017

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: Stable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was used after being reduced in fine powder in the study.

FORM AS APPLIED IN THE TEST
As such.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Remarks:

1 Female & 2 Male

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: supplied by Hypharm (F-49450 La Renaudiere).
- Age at study initiation: the female rabbit was 10 or 11 weeks old and the male rabbits were 10, 11 or 12 weeks old
- Housing: individual box installed in conventional air-conditioned animal husbanding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5-day acclimatisation period

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17°C to 23°C
- Humidity (%): 30% to 70%
- Air changes (per hr): at least ten changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (07.00 to 19.00) and twelve hours darkness

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 g of the test item was instilled, after being reduced in fine powder, into the conjunctival sac of one eye after gently pulling the lower lid away from the eyeball.

VEHICLE
No vehicle used

Observation period (in vivo):

1 hour, 24, 48 and 72 hours following treatment.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: No washing
- Time after start of exposure: Residual test item requiring a physiological saline rinse off was noted at the reading time 1 hour in all animals.

SCORING SYSTEM:
As recommanded by the OECD Guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible

Results 7

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 9

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 11

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 12

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

The ocular reactions observed during the study have been slight and totally reversible:
- at the conjunctivae level: a slight redness noted 1 hour after the test item instillation in all animal and totally reversible between Days 1 and 2. This reaction was associated with a slight chemosis noted 1 hour after the test item instillation in all animals and totally reversible between day 1 and day 2.
- at the corneal level: a slight opacity noted 24 hours after the test item instillation in one animal and totally reversible on day 2.

Any other information on results incl. tables

Animal n° Weiht (kg)	Time after treatment	CONJUCTIVAE		IRIS	CORNEA
		CHEMOSIS (A)	REDNESS (C)	LESION (D)	OPACITY (E)
A7105	24 hours	0	0	0	1
	48 hours	0	0	0	0
	72 hours	0	0	0	0
Start: 2.09	TOTAL	0	0	0	1
End: 2.24	Mean	0.0	0.0	0.0	0.3
A7092	24 hours	1	1	0	0
	48 hours	0	0	0	0
	72 hours	0	0	0	0
Start: 2.55	TOTAL	0	0	0	0
End: 2.67	Mean	0.3	0.3	0.0	0.0
A7093	24 hours	0	0	0	0
	48 hours	0	0	0	0
	72 hours	0	0	0	0
Start: 2.71	TOTAL	0	0	0	0
End: 2.84	Mean	0.0	0.0	0.0	0.0
CLASSIFICATION	According to the calculated means, the test item does not have to be classified

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The results obtained, under these experimental conditions, enable to conclude that the test item STRONTIUM OXALATE does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
No symbol and warning label are required.

Executive summary:

The test item STRONTIUM OXALATE was instilled, as supplied, into the eye of three New Zealand rabbits at the dose of 0.1 g.

The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. Test Guideline No. 405 dated October 9th, 2017.

The ocular reactions observed during the study have been slight and totally reversible:

- at the conjunctivae level: a slight redness noted 1 hour after the test item instillation in all animal and totally reversible between Days 1 and 2. This reaction was associated with a slight chemosis noted 1 hour after the test item instillation in all animals and totally reversible between day 1 and day 2.

- at the corneal level: a slight opacity noted 24 hours after the test item instillation in one animal and totally reversible on day 2.

In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item STRONTIUM OXALATE does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.

No symbol and warning label are required.