Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Minor deviations were noted however these did not have any impact on the study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Minor deviations were noted but these did not have any impact on the study
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
same as above
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
yes
Remarks:
same as above
Principles of method if other than guideline:
not applicable
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
HES10108 (supplied as Dow Corning BY 16-122B
- Expiration date of the lot/batch:
25-August-2017 / Lot number 0008624816
- Purity test date:
-14-April-2016

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
0°C -32 °C, protected from light. Do not store with strong
oxidising agents
- Stability under test conditions:
the liquid test item was tested undiluted
- Solubility and stability of the test substance in the solvent/vehicle:
not applicable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
not applicable

Other
- Physical state - liquid
- Color - colorless
- Active components - 95%: 3-Methacryloxypropyltris {[tris(trimethylsiloxy) silyl]
ethyldimethylsiloxy} silane
- Purity - 99.3% (non-volatile content)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand Black
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: approximately 19-20 weeks old
- Weight at study initiation: > 2.0 kg
- Housing: Housed in ABS-plastic or Noryl rabbit cages, floor 4200 cm 2
- Diet (e.g. ad libitum): Free access autoclaved hay and to Altromin 2123 maintenance diet for rabbits, rich in crude fibre
- Water (e.g. ad libitum): Free access to tap water (drinking water, municipal residue control, microbiological controls at
regular intervals)
- Acclimation period: Adequate acclimatisation period (at least 5 days) under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 55 ± 10%
- Air changes (per hr): Air change: at least 10 x / hour
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
A dose of 0.1 mL of the test item was applied to the test site
Duration of treatment / exposure:
single application
Observation period (in vivo):
The animals were observed for 72 hours after dosing
Duration of post- treatment incubation (in vitro):
not applicable
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was not rinsed after the application

SCORING SYSTEM: The eyes were examined for signs of irritation throughout the observation period. The eye irritation was scored and recorded according to the Draize grades

TOOL USED TO ASSESS SCORE: At the end of the observation period the treated eyes were examined with the aid of a fluorescein solution. The eyes were rinsed with physiological saline 0.9% NaCI after the examination.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other:
Remarks:
not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other:
Remarks:
not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other:
Remarks:
not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0.33 - 0.67
Max. score:
1
Reversibility:
fully reversible within:
Remarks:
72 hours
Remarks on result:
probability of weak irritation
Irritant / corrosive response data:
After the application into the eyes of three male NZW rabbits the test item produced slight irritant effects in all animals, which were fully reversible within 48 hours in animals no. 1 and no. 2 and 72 hours in animal no. 3. No corrosive effects were observed in any animals. Upon fluorescein examinations at the end of the observation period of 72 hours no corneal lesions were found in any animal
Other effects:
Neither mortalities nor significant clinical signs of toxicity but local effects were observed

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 HES10108 (Supplied as DOW CORNING® BY 16-122 B) to rabbits at a dose of 0.1 mL produced slight irritant effects, which were fully reversible within 48 hours in animals no. 1 and no. 2 and within 72 hours in animal no. 3. Neither mortalities nor significant clinical signs of toxicity were observed.
According to Annex I of Regulation (EC) 1272/2008 [9], the test item HES10108 (Supplied as DOW CORNING® BY 16-122 B) has no obligatory labelling requirement for eye irritation and according to GHS (Globally Harmonized Classification System) [10] the test item HES1 01 08 (SuJJJJlied as DOW CORNING® BY '16-'122 B) has no obligatory labelling requirement for eye irritation ,
Executive summary:

In this eye irritation/corrosion study (conducted according to OECD Guideline 405, EU Method B.5 and EPA OPPTS 870.2400 and in accordance with GLP), three rabbits were administered a single ocular application of HES10108 (Supplied as DOW CORNING® BY 16 -122 B) at a dose of 0.1 ml and evalauted for ocular irritation/corrosion effects.

Under the conditions of the present study, a single ocular application of the test item HES10108 (Supplied as DOW CORNING® BY 16-122 B) to rabbits at a dose of 0.1 mL produced slight irritant effects, which were fully reversible within 48 hours in animals no. 1 and no. 2 and within 72 hours in animal no. 3. Neither mortalities nor significant clinical signs of toxicity were observed.

According to Annex I of Regulation (EC) 1272/2008 [9], the test item HES10108 (Supplied as DOW CORNING® BY 16-122 B) has no obligatory labelling requirement for eye irritation and according to GHS (Globally Harmonized Classification System) [10] the test item HES1 01 08 (SuJJJJlied as DOW CORNING® BY '16-'122 B) has no obligatory labelling requirement for eye irritation ,