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Diss Factsheets

Administrative data

Description of key information

Skin irritation (OECD 404): not irritating
Eye irritation (OECD 405): not irritating

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:
16 - 20 Jan 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Behörde für Soziales, Familie, Gesundheit und Verbraucherschutz, Hamburg, Germany
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Sulzfeld, Germany
- Age at study initiation: approx. 3 months
- Weight at study initiation: 2.5-2.8 kg
- Housing: before and after the 4-hour exposure period, the animals were kept singly in cages measuring 380 mm x 425 mm x 600 mm (Dipl. Ing. W. EHRET GmbH, Schönwalde, Germany). During the exposure period, the animals were kept singly in restrainers which allowed free movement of the head, but prevented a complete body turn. The cages excluded irritation of the skin by excrements and urine.
- Diet: sniff® K-H V2333 (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: drinking water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 16 Jan 2012 To: 20 Jan 2012
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm² on the dorsal area of the trunk
- Type of wrap if used: the test item was applied to the test site and then covered with a gauze patch. The patch was held in place with non-irritating tape for the duration of the exposure period.

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
In the initial test with one animal, no severe irritancy or corrosion was product by the test substance at any reading time point. In the confirmatory test with 2 further animals, no erythema or edema were observed 1, 24, 48 and 72 h after exposure.
Other effects:
No further local or systemic effects were observed.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study
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
GLP compliance:
yes (incl. QA statement)
Remarks:
Behörde für Soziales, Familie, Gesundheit und Verbraucherschutz, Hamburg, Germany
Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology GmbH & Co. KG, branch Löhndorf, 24601 Löhndorf/Post Wankendorf, Germany
- Age at study initiation: approx. 7-9 months
- Weight at study initiation: 2.5-2.8 kg
- Housing: For 8 hours following test substance application, the animals were kept singly in restrainers which allowed free movement of the head but prevented a complete body turn, wiping of the eyes with the paws and excluded irritation of the eye by excrements and urine. Before and after the 8-hour period , the animals were kept singly in cages with dimensions of 380 mm x 425 mm x 600 mm (manufacturer: Dipl.Ing. W. EHRET GmbH, 16352 Schönwalde, Germany).
- Diet: ssniff® K-H V2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany); ad libitum
- Water: tap water; ad libitum
- Acclimation period: at least 20 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 29 Oct - 01 Dec 2012
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL


Duration of treatment / exposure:
Single application without washing
Observation period (in vivo):
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Drainze scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibilty: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
At 1 h post application, conjunctival redness (score 1) was noted in 2 of 3 animals. However, the effect was fully reversible within 24 h. No effects on conjunctival chemosis, iris or cornea were observed during the study period.
Other effects:
There were no systemic intolerance reactions.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The UVCB substance "hydrolysis products of 3-(triethoxysilyl)propan-1-amine" is a complex reaction product obtained from hydrolysis of 3-(triethoxysilyl)propan-1-amine in water. The test substance consists of monomers, dimers and polymers of siloxanes as well as ethanol. The concentration range of each constituent depends on the manufacturing condition (e.g. the ratio of 3-(triethoxysilyl) propan-1-amine and water). Typical concentrations of the test substance obtained from hydrolysis of an aqueous solution of 8% 3-(triethoxysilyl)propan-1-amine are described below: ca. 0.52% (w/w) 3-aminopropylsilanetriol (monomer, CAS 58160-99-9), ca. 0.7% (w/w) 1,3-bis(3-aminopropyl)disiloxane-1,1,3,3-terol (dimer), ca. 3% (w/w) hydrolysed polymers of 3-aminopropyltriethoxysilane, ca. 4.99% (w/w) ethanol (CAS 64-17-5) and ca. 90.79% water.

Hydrolysis product of 3-(triethoxysilyl)propan-1-amine (8%) was chosen for testing skin and eye irritation in animals as this concentration represents a typical concentration in the manufacturing process.

The skin irritation study was performed in accordance with OECD 404 (Leuschner, 2012). The test substance was an aqueous solution of 3-(triethoxysilyl)propan-1-amine (8%) which was neutralised to pH 6 before testing. The test substance (0.5 mL) was applied to the intact skin of rabbits and covered with a gauze patch. Under semi-occlusive conditions, the gauze patch was held in place with an adhesive tape for an exposure period of 4 h. Thereafter, the gauze patch was removed and the treated skin site was assessed. Evaluation of the treated skin sites was done 1, 24, 48 and 72 h after patch removal. There were no signs of skin irritation at the treated skin sites. All scores at any observation time points were 0. Under the conditions of the test, the test substance at a pH of 6 was not irritating to the skin.

Hydrolysis products of 3-(triethoxysilyl)propan-1-amine (8%) neutralised to pH 6 was tested for eye irritation in rabbits. According to OECD 405, the test substance (0.1 mL) was placed into the conjunctival sac of the right eye of each rabbit (Hansen, 2013). The left eye remained untreated and was used for control. 1, 24, 48 and 72 h after test substance instillation, the grades of ocular reaction (conjunctivae redness, conjunctivae chemosis, cornea, iris) were assessed. At 1 h post application, conjunctival redness (score 1) was noted in 2 of 3 animals. However, the effect was fully reversible within 24 h. No effects on conjunctival chemosis, iris or cornea were observed during the study period. Under the conditions of the test, the test substance at a pH of 6 was not irritating to the eyes.


Justification for selection of skin irritation / corrosion endpoint:
There is only one study available.

Justification for selection of eye irritation endpoint:
There is only one study available.

Justification for classification or non-classification

The available data on skin and eye irritation of the test substance do not meet the criteria for classification according to Regulation (EC) No 1272/2008 and are therefore conclusive but not sufficient for classification.