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Diss Factsheets

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:
from 28th may 2012 to 3rd June 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study in compliance with international recognized guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes

Test material

1
Chemical structure
Reference substance name:
Tin dioxide
EC Number:
242-159-0
EC Name:
Tin dioxide
Cas Number:
18282-10-5
Molecular formula:
O2Sn
IUPAC Name:
tin(4+) dioxidandiide
Test material form:
solid: nanoform
Details on test material:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material:
2012-000203
- Expiration date of the lot/batch:
07/02/2013, W0167
- Purity test date:
> 99.9%, 23/01/2011



INFORMATION ON NANOMATERIALS
- Chemical Composition:
Tin Dioxide
- Density:
6.936 g/cm³
- Particle size & distribution:
10-100 nm; 78
- Specific surface area: 7.4293 ± 0.0132 m²/g

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Species/strain: healthy New Zealand White Rabbits, Crl: KBL (NZW)
Source: Charles River Deutschland, 97633 Sulzfeld, Germany
Sex: female
Body weight at the beginning of the study: > 2 kg
Age at the beginning of the study: approximately 17 - 18 weeks old
Number of animals: 3
The animals were derived from a controlled full -barrier maintained breeding system (SPF). According to Art. 9.2, No. 7 of the German Act on Animal Welfare [9] the animals were bred for experimental purposes.
- Semi barrier in an air-conditioned room
- Temperature: 18± 3 °C
- Relative humidity: 55±10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: at least 10 x / hour
- Free access to autoclaved hay and to Altromin 2123 maintenance diet for rabbits (lot no. 1530), rich in crude fibre
- Free access to tap water (drinking water, municipal residue control, microbiological controls at regular intervals)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE - Housed in ABS - plastic rabbit cages, floor 4200 cm2
- Adequate acclimatisation period (at least 5 days) under laboratory conditions

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
single dose of 0.1 g was appliedin the conjuntival sac of one eye.
Duration of treatment / exposure:
single dose
Observation period (in vivo):
72 hours after dosing.
Number of animals or in vitro replicates:
The in vivo test was performed initially using one animal then two additional animals were treated to confirm the first response.
Details on study design:
24 hours before the test an health inspection was performed to ensure the good state of health of the animals.
One hour before the application of the test item, 0.01 mg/Kg of byprenorphine was administareted subcutaneously in order to achieve a therapeutic level of systemic analgesia.
5 minutes prior to the application of the test item, 2-3 drops of an ocular anaesthetic ( proparacaine hydrochloride ophtalmic 0.5% solution) were administrated in both the treated and the control eye of each animal.
The test item was applied at a single dose in the conjunctival of one eye of each test animal after pulling the lower lid away from the eyeball. The lids were gently held together for about 1 second in order to prevent loss of the material. The untreated contralateral eye served as control.
The animals were observed for 72 hours after dosing.
The eye irritation was scored and recorded according to the grades reported in the field "attached background material".
For the calculation only the 24, 48 and 72 hours were used.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 1 hour
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1h
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 hour
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The test item produced irritant but not corrosive effects in all animals.
Conjuntival redness was observed in all animals one hour post-application.
Conjuntival chemosis and discharge were observed only in animal n.2 and 3 one hour after application. These changes were fully reversible within 24 hours.
Other effects:
Neither mortalities nor significant clinical signs of toxicity were observed.
Upon fluoreshein examinations at the end of the observation period of 72 hours no corneal lesions were found in any animal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the present study, a single ocular application of the test item Tin dioxide to rabbits at a dose of 0.1 g produced slight initial irritant effects. Neither mortalities nor significant clinical signs of toxicity were observed.
According to the CLP criteria for classification and labelling requirements for dangerous substances the test item Tin dioxide is not to be classified as eye irritant.