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Description of key information

No skin or eye irritation/corrosion is observed.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source of test material: Bernardy, STRONTIUM OXALATE
- batch No.: 1702507
- Purity test date: 13/01/2017
- date of reception: 19/12/2017
- Expiry date: 13/01/2022

STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
Test system:
human skin model
Justification for test system used:
Test system recommended in the OECD 439 Guideline.
Vehicle:
water
Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: SkinEthic RHE® model
- Tissue batch number(s): 18-RHE-012
- Delivery date: received on 13 February 2018

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C

REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 42 minutes after the test item application, the nylon mesh was removed and the human epidermises were washed with 25 x 1 mL of DPBS (Dutscher - Batch No. 3941117).
- Observable damage in the tissue due to washing: No (comparable coloration to that of the negative control tissues)

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 42 hours post-treatment incubation period (after 42 min of exposure)

FUNCTIONAL MODEL CONDITIONS
- Viability:
Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues. The mean percent viability of the treated tissues was 104.3% (considered as 100%) versus 1.1% in the positive control (5% Sodium Dodecyl Sulfate).
The results were expressed as a viability percentage compared with the negative control : Viability % = OD test item / OD negative control x100

NUMBER OF REPLICATE TISSUES:
Three replicates used for each test chemical and for the controls : 3 replicates for test item, 3 for negative control, 3 for positive control

PREDICTION MODEL / DECISION CRITERIA
The test item is considered as non-irritant to skin in accordance with UN GHS No Category if the mean percent viability after 42 minutes exposure and 42 hours of post-treatment incubation is > 50%.
The test item is identified as requiring classification and labelling according to UN GHS (Category 2) if the mean percent tissue viability after 42 minutes exposure and 42 hours of post-treatment incubation is ≤ 50% and the result of a skin corrosion test is “non-corrosive”.
The test item is identified as requiring classification and labelling according to UN GHS (Category 2 or Category 1) if the mean percent tissue viability after 42 minutes exposure and 42 hours of post-treatment incubation is ≤ 50% and in absence of information on a skin corrosion test.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
TEST MATERIAL
- Amount applied: dose of 16 mg to the epidermal surface of 3 living Reconstructed Human epidermis previously moistened with 10 μL of distilled water.

VEHICLE
- Amount(s) applied (volume or weight with unit): Reconstructed Human epidermis previously moistened with 10 μL of distilled water.

NEGATIVE CONTROL
DPBS – Dutscher - Batch No. 3941117
- Amount applied: 0.5 g of SDS (SIGMA Batch No. STBG6142V) in a 10 mL volumetric flask qsp 10 mL of distilled water.

POSITIVE CONTROL
5% sodium dodecyl sulfate (SDS)
- Amount applied: in a 10 mL volumetric flask
Duration of treatment / exposure:
42min (application)
Duration of post-treatment incubation (if applicable):
42 hours
Number of replicates:
3 for each test chemical and for the controls (3 replicates for test item, 3 for negative control, 3 for positive control).
Irritation / corrosion parameter:
% tissue viability
Value:
104.3
Negative controls validity:
valid
Positive controls validity:
valid
Interpretation of results:
GHS criteria not met
Conclusions:
In accordance with the Regulation EC No. 1272/2008, the test item STRONTIUM OXALATE has to be considered as Non-irritant to skin. It corresponds to UN GHS No Category.
No hazard statement or signal word is required.
Executive summary:

An OECD 439 test was performed on Strontium oxalate in order to investigate the corrosion/irritation potential. In accordance with the Regulation EC No. 1272/2008, the test item STRONTIUM OXALATE has to be considered as Non-irritant to skin. It corresponds to UN GHS No Category. No hazard statement or signal word is required.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
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.
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
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
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
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.

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification

Since no effect is observed under OECD tests, no classification is required.