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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:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented, according to accepted guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
- 1987 followed, reliability score based on 2002 guideline
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
- 1992
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Aluminium fluoride
EC Number:
232-051-1
EC Name:
Aluminium fluoride
Cas Number:
7784-18-1
Molecular formula:
AlF3
IUPAC Name:
aluminum trifluoride
Details on test material:
- Name of test material (as cited in study report): AlF3, Aluminium fluoride
- Physical state: dry solid, white powder
- Analytical purity: not reported
- Lot/batch No.: XP01_00008_01
- Expiration date of the lot/batch: not reported
- Storage condition of test material: room temperature, in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River, Stolzenseeweg 32-36, D-88353 Kisslegg, Germany
- Age at study initiation: not reported
- Weight at study initiation: 3.1-3.9 kg
- Housing: individually in PPO-plast cages (Noryl®, floor area 2576 cm²) with perforated floor
- Diet (e.g. ad libitum): pelleted complete rabbit diet "Altromin 2123 " from Chr. Petersen, DK-4100 Ringsted, ad libitum
- Water (e.g. ad libitum): domestic quality drinking water acidified with HCl to pH 2.5 in order to prevent microbial growth, ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 55 ± 15%
- Air changes (per hr): 10 per hr
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g placed in the left eye
Duration of treatment / exposure:
A volume of 0.1 g of the test article was placed in the left eye of the rabbits by gently pulling the lower lid away from the eyeball to form a cup into which the article was dropped placed. The lids were then gently held together for 1 second.
Observation period (in vivo):
Following exposure, the eyes were examined at 1 and 24 hours and the grade of ocular reaction was recorded. After the 24 hour reading and Fluorescein instillation, the eyes were examined again using UV-light to detect possible corneal damage. The eyes were also examined 48 and 72 hours after the treatment.
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After rinsing with 20 mL 0.9% NaCl, the eyes were examined again using UV-light to detect possible corneal damage.
- Time after start of exposure: 24 hours


SCORING SYSTEM: see scoring scale in next section.


TOOL USED TO ASSESS SCORE: The day before testing, both eyes of the animals were examined with a hand held inspection lamp fitted with white and UV-light and magnifying glass with 2 x magnification to ensure there were no defects or irritation. The examination was performed before and after instillation of Fluorescein. Following exposure, the eyes were examined and the grade of ocular reaction was recorded at 1 and 24 hours. After the 24 hour reading, Fluorescein was instilled. After rinsing with 20 mL 0.9% NaCl, the eyes were examined again using UV-light to detect possible corneal damage. The eyes were also examined 48 and 72 hours after the treatment.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
- degree
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no reaction observed
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: no reaction observed
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
- redness
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Remarks:
- degree
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no reaction observed
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: no reaction observed
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
- redness
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Remarks:
- degree
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no reaction observed
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: no reaction observed
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no reaction observed
Irritation parameter:
conjunctivae score
Remarks:
- redness
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
See attached Table 1 for results.

Any other information on results incl. tables

The individual results are shown in Table 1 (attached). Signs of conjunctival irritation (chemosis, redness and discharge) were observed in two rabbits 1 to 48 hours after termination of exposure and in one rabbit 1 to 24 hours after termination of exposure. 72 hours after termination of exposure no abnormalities were observed in the eyes of any of the rabbits.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: other: CLP (1272/2008)