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Administrative data

Description of key information

In a skin irritation/corrosion study (conducted according to OECD Guideline 404, EU Method B.4 and EPA OPPTS 870.2500 and in accordance with GLP), three rabbits were dermally exposed, under semi-occlusive conditions to HES10108 (Supplied as DOW CORNING® BY 16 -122 B) at a dose of 0.5 ml for 4 hours and evalauted for skin irritation/corrosion effects.

Under the conditions of the present study, the single dennal application of the test item HES10108 (Supplied as DOW CORNING® BY 16-122 B) to three rabbits at a dose of 0.5 mL showed neither irritant nor corrosive effects.

Neither mortalities nor significant clinical signs of toxicity were observed.

According to Annex I of Regulation (EC) 1272/2008, the test item HES10108 (Supplied as DOW CORNING® BY 16-122 B) does not have to be classified and has no obligatory labelling requirement for skin irritation and according to GHS (Globally Harmonized Classification System), the test item HES10108 (Supplied as DOW CORNING® BY 16-122 B) has no obligatory labelling requirement for skin irritation.

In a 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

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin 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:
There were no deviations from the study plan
Justification for type of information:
not applicable
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes
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)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: approximately 20-22 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 to 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): at least 10 x / hour
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark

IN-LIFE DATES: From: 18-July-2016 To: 4-August-2016
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Remarks:
Approximately 24 hours (animals no. 1 and no. 2) and 23 hours (animal no. 3) before the test, the fur was removed from the dorsal area of the trunk by using an electric clipper. Care was taken to avoid abrading the skin.
Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated other side served as control
Amount / concentration applied:
A dose of 0.5 mL of the test item was applied to each test site
Duration of treatment / exposure:
The test item was held in contact with the skin throughout a 4-hour period. At the end of the exposure period, the residual test item was removed with physiological saline 0.9% NaCI.
Observation period:
The animals were observed for 72 hours after the patch removal
Number of animals:
The test item was not expected to produce corrosion, but might be irritating. Therefore, a single patch was applied to one animal for 4 hours. Subsequently, the reminder 2 rabbits were exposed derammly.
Details on study design:
TEST SITE
The test item was applied at a single dose to a small area (approximately 6 cm2) of skin on one side of the dorsal area and covered with a gauze patch, which was held in place with a non-irritating tape. The untreated other side served as control. The test item was applied to the patch first and then applied to the skin. The patch was fixed with a semi-occlusive dressing. The limits of the application site were marked with an ink marker

REMOVAL OF TEST SUBSTANCE
At the end of the exposure period, the residual test item was removed with physiological saline 0.9% NaCI.

OBSERVATION TIME POINTS
The animals were examined for signs of erythema and oedema 1 hour after the patch removal. For the determination of classification-relevant values, the animals were examined for signs of erythema and oedema 24, 48 and 72 hours after the patch removal.

SCORING SYSTEM:
- Method of calculation: Dermal irritation was scored and recorded according to the grades as per Draize score
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 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
Remarks:
Neither irritant nor corrosive effects were observed on the intact skin of three female rabbits (strain NZW) after a contact time of 4 hours
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 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
Irritant / corrosive response data:
Neither irritant nor corrosive effects were observed on the intact skin of three female rabbits (strain NZW) after a contact time of 4 hours
Other effects:
No adverse changes were observed at the skin sites.There were no significant body weight changes during the observation period.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the present study, the single dennal application of the test item HES1 01 08 (Supplied as DOW CORNING® BY 16-122 B)to three rabbits at a dose of 0.5 mL showed neither irritant nor corrosive effects.
Neither mortalities nor significant clinical signs of toxicity were observed.
According to Annex I of Regulation (EC) 1272/2008, the test item HES10108 (Supplied as DOW CORNING® BY 16-122 B) does not have to be classified and has no obligatory labelling requirement for skin irritation.
According to GHS (Globally Harmonized Classification System), the test item HES10108 (Supplied as DOW CORNING® BY 16-122 B) has no obligatory labelling requirement for skin irritation.
Executive summary:

In this skin irritation/corrosion study (conducted according to OECD Guideline 404, EU Method B.4 and EPA OPPTS 870.2500 and in accordance with GLP), three rabbits were dermally exposed, under semi-occlusive conditions to HES10108 (Supplied as DOW CORNING® BY 16 -122 B) at a dose of 0.5 ml for 4 hours and evalauted for skin irritation/corrosion effects.

Under the conditions of the present study, the single dennal application of the test item HES10108 (Supplied as DOW CORNING® BY 16-122 B) to three rabbits at a dose of 0.5 mL showed neither irritant nor corrosive effects.

Neither mortalities nor significant clinical signs of toxicity were observed.

According to Annex I of Regulation (EC) 1272/2008, the test item HES10108 (Supplied as DOW CORNING® BY 16-122 B) does not have to be classified and has no obligatory labelling requirement for skin irritation and according to GHS (Globally Harmonized Classification System), the test item HES10108 (Supplied as DOW CORNING® BY 16-122 B) has no obligatory labelling requirement for skin irritation.

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:
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
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
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)
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

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.
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
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 ,

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

As the test substance HES 10108 (DOW CORNING® BY 16-122 B) did not show any irritation potential in both the skin and eye irritation/corrosion studies, according to Annex I of Regulation (EC) 1272/2008, the test item HES10108 (Supplied as DOW CORNING® BY 16-122 B) does not have to be classified and has no obligatory labelling requirement for skin/eye irritation and according to GHS (Globally Harmonized Classification System), the test item HES10108 (Supplied as DOW CORNING® BY 16-122 B) has no obligatory labelling requirement for skin/eye irritation.