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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:
December 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Strontium di(acetate)
EC Number:
208-854-8
EC Name:
Strontium di(acetate)
Cas Number:
543-94-2
Molecular formula:
Sr(C2H3O2)2
IUPAC Name:
strontium di(acetate)
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- identification: STRONTIUM ACETATE
- Batch No.: 17025 25/26/28
- Cas No.: 14692-29-6
- Date received: 13 June 2017
- Storage: room temperature
- Container: opaque plastic flask (n=1)
- Form: fine crystals
- Quantity: 25.40 g (container + content)
- Colour: white
- Production date: 13 May 2017
- Expiry date:13 May 2020

It was identified under the code number: PH-17/0377. The test item was used as supplied in the study.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Animals:
Three female albino New Zealand rabbits were supplied by Hypharm (F-49450 La Renaudiere). The animals were kept during a minimal 5-day acclimatisation period. At the beginning of the test, the animals were 11 weeks old. They were identified prior to inclusion in the test by means of a numbered ring on the edge of one ear.

Housing:
Each animal was kept in an individual box installed in conventional air conditioned animal husbanding:
The temperature and relative humidity of the main test were controlled to remain within target ranges of 17°C to 23°C and 30% to 70%, respectively.
The rate of air exchange was at least ten changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.

Food and drink:
Drinking water (tap-water from public distribution system) and foodstuff (ENVIGO – 2030C) were supplied ad libitum.
Microbiological and chemical analyses of the water were carried out once every six months by Bureau Veritas - Eurofins (FRANCE).

Treatment:
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. The lids were then gently held together for about one second in order to prevent loss of the test item. The other eye remained untreated serving as control.
Initially, a single animal was treated. After consideration of the responses in the first animal, two additional animals were treated under the same experimental conditions.

Grading of reactions:
Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration 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.
Duration of treatment / exposure:
Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.
Observation period (in vivo):
Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.
Number of animals or in vitro replicates:
Three female albino New Zealand rabbits.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Remarks:
Mean
Basis:
animal: A6670
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
Redness (mean)
Basis:
animal: A6670
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
iris score
Remarks:
mean
Basis:
animal: A6670
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Remarks:
mean
Basis:
animal: A6670
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Remarks:
mean
Basis:
animal: A6674
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
Redness (mean)
Basis:
animal: A6674
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Remarks:
mean
Basis:
animal: A6674
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Remarks:
mean
Basis:
animal: A6674
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Remarks:
mean
Basis:
animal: A6675
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
Redness (mean)
Basis:
animal: A6675
Time point:
24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Remarks:
mean
Basis:
animal: A6675
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Remarks:
mean
Basis:
animal: A6675
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritant / corrosive response data:
The ocular reactions observed during the study have been slight to moderate and totally reversible:
- At the conjunctivae level: a slight to moderate redness noted 24 hours after the test item instillation and totally reversible between days 2 and 3; associated with a slight to moderate chemosis noted 1 hour after the test item instillation and totally reversible between days 2 and 3.
- At the iris level: an injection was noted 1 hour after the test item instillation in two animals and was totally reversible on day 1.
- At the corneal level: a slight opacity, noted 24 hours after the test item instillation in two animals and totally reversible on day 2.

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 ACETATE 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 ACETATE 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 2nd, 2012.

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

- At the conjunctivae level: a slight to moderate redness noted 24 hours after the test item instillation and totally reversible between days 2 and 3; associated with a slight to moderate chemosis noted 1 hour after the test item instillation and totally reversible between days 2 and 3.

- At the iris level: an injection was noted 1 hour after the test item instillation in two animals and was totally reversible on day 1.

- At the corneal level: a slight opacity, noted 24 hours after the test item instillation in two animals and totally reversible on day 2.

In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item STRONTIUM ACETATE 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.

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