Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 213-048-4 | CAS number: 919-30-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
The key skin irritation/corrosion study, conducted according to a protocol similar to OECD Test guideline 404 but without information about GLP compliance, found 3-aminopropyl(triethoxy)silane to be corrosive to skin (BRRC, 1990a).
The key eye irritation/corrosion study, conducted according to a protocol similar to OECD Test Guideline 405 but without information about GLP compliance, found 3-aminopropyl(triethoxy)silane to be severely irritating with necrosis to the eyes (BRRC, 1989).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- See below
- Principles of method if other than guideline:
- No guideline is specified. This study approximates in many respects to OECD 404 including observations for 14 days. The neat material (0.5 ml) was held in occlusive contact for 1 h or 3 min with the shaved skin of 6 rabbits. Insufficient details are given on the purity of the test substance, animals used, test site and animal housing conditions.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no details given
- Age at study initiation: no details given
- Weight at study initiation: no details given
- Housing: no details given
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: no details given
ENVIRONMENTAL CONDITIONS
no details given
IN-LIFE DATES: no details given - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 ml
- Concentration: neat - Duration of treatment / exposure:
- 1 h
3 min - Observation period:
- 14 days
- Number of animals:
- 6 (for each exposure time)
Two animals in the 1-min test were terminated after day 10 for reasons of space. - Details on study design:
- TEST SITE
- Area of exposure: not stated
- % coverage: not stated
- Type of wrap if used: gauze covered with loosely held occlusive wrap
REMOVAL OF TEST SUBSTANCE
- Washing: excess removed after exposure
- Time after start of exposure: 1 h; 3 min
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Remarks:
- 1-hour exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 1-hour exposure
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 1-hour exposure
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 1-hour exposure
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 1-hour exposure
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 1-hour exposure
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 1-hour exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 1-hour exposure
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 1-hour exposure
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 1-hour exposure
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 1-hour exposure
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 1-hour exposure
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 3-min exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 3-min exposure
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 3-min exposure
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 3-min exposure
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 3-min exposure
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 3-min exposure
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 3-min exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 3-min exposure
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 3-min exposure
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 3-min exposure
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 3-min exposure
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 3-min exposure
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 1-h occlusive contact caused well-defined to moderate erythema and slight to moderate oedema in all 6 animals, still present at the 3-day observation but not at 7 days. Necrosis that was full thickness in 2/6 and superficial in 2/6 was evident until observation at day 10, but absent at day 14. Ecchymosis (a hemorrhagic area ) was apparent in 4/6 within 2 h but absent by day 2. Scabbing, desquamation or alopecia were still present in all 4 of the remaining animals at termination on day 14. See table 1.
Exposure for 3 min caused slight to well-defined erythema and very slight to slight oedema in 6/6 that remained in some until day 3 but was not evident on day 7. The only other effect reported was desquamation present in 6/6 at the final 7-day observation. See table 2. - Other effects:
- None reported.
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- A reliable study, conducted in a manner largely similar to OECD 404, found the neat test material to be corrosive when in occluded contact for 1 h, and a minor to moderate irritant when in contact for 3 min. There is no evidence of GLP status in the report, however, Bushy Run Research Center was a certified GLP laboratory during the period of the conduct of this study.
Reference
Tables from the study report with individual scores for each animal can be found under attachments
Table 1: Exposure for 1 hour
Irritant/corrosive response data (mean for 6 animals) at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema & eschar (mean of 6) |
Edema (mean of 6) |
Other effects (number of animals with each effect shown) |
Max. score: 4 |
Max. score: 4 |
||
2 h |
2.3 |
2.3 |
2N, 4E |
24 h |
2.2 |
2.5 |
2N+, 2E, 1S |
48 h |
2.5 |
2.5 |
2N+, 1N, 1E, 1S |
72 h |
2.3 |
1.5 |
2N+, 2N, 1D, 1S |
Day 7 |
0.0 |
0.0 |
1N+, 2N, 6D, 2S, 3A |
Day 10 |
0.0 |
0.0 |
1N+, 6D, 2S, 5A |
Day 14 (4 animals) |
0.0 |
0.0 |
4D, 2S, 4A |
Mean 24, 48, 72 h |
2.3 |
2.2 |
- |
Reversibility* |
nc |
||
Average time (unit) for reversion |
Not fully reversed within 14 days |
Table 2: Exposure for 3 minutes
Irritant/corrosive response data (mean for 6 animals) at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema & eschar (mean of 6) |
Edema (mean of 6) |
Other effects (number of animals with each effect shown) |
Max. score: 4 |
Max. score: 4 |
||
2 h |
1.5 |
1.0 |
- |
24 h |
1.7 |
1.2 |
- |
48 h |
1.5 |
0.7 |
1D |
72 h |
1.2 |
0.2 |
1D |
Day 7 |
0.0 |
0.0 |
6D |
Mean 24, 48, 72 h |
1.5 |
0.7 |
- |
Reversibility* |
nc |
||
Average time (unit) for reversion |
Not fully reversed within 7 days |
* Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
N+ = full thickness necrosis
N = superficial necrosis
D = desquamation
E = ecchymosis
S = scab formation
A = alopecia
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
- Remarks:
- SIAR (2003) notes that this laboratory was GLP certified at the date of this study
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no details given
- Age at study initiation: : no details given
- Weight at study initiation: no details given
- Housing: no details given
- Diet: standard diet ad libitum
- Water : drinking water ad libitum
- Acclimation period: no details
ENVIRONMENTAL CONDITIONS
no details given
IN-LIFE DATES: no details given - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye usually serves as the control
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml, 0.005 ml - Duration of treatment / exposure:
- Eyes unwashed.
- Observation period (in vivo):
- Observation to 21 days in some cases
- Number of animals or in vitro replicates:
- 6 (3/sex)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: unwashed
SCORING SYSTEM: after Draize, 1959
TOOL USED TO ASSESS SCORE: fluorescein (for 1-day reading) - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- 0.1 ml
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- Score of 4 at 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- 0.1 ml
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- Score of 4 at 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- 0.1 ml
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- Score of 4 at 7.0 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Remarks:
- 0.1 ml
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- Score of 4 at 7.0 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Remarks:
- 0.1 ml
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- Score of 4 at 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Remarks:
- 0.1 ml
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- Score of 2 at 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- 0.1 ml
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- Score of 1 at 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- 0.1 ml
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- Score of 2 at 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- 0.1 ml
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- Score of 1 at 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Remarks:
- 0.1 ml
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- Score of 2 at 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Remarks:
- 0.1 ml
- Time point:
- 24/48/72 h
- Score:
- 2.66
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- Score of 2 at 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Remarks:
- 0.1 ml
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- Score of 1 at 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- 0.1 ml
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- Score of 1 at 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- 0.1 ml
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- Score of 1 at 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- 0.1 ml
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- Score of 1 at 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Remarks:
- 0.1 ml
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- Score of 1 at 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Remarks:
- 0.1 ml
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- Score of 2 at 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Remarks:
- 0.1 ml
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- Score of 1 at 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- 0.1 ml
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- other: Scoring not possible at 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- 0.1 ml
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- other: Scoring not possible at 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- 0.1 ml
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- other: Scoring not possible at 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Remarks:
- 0.1 ml
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- other: Scoring not possible at 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Remarks:
- 0.1 ml
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- other: Scoring not possible at 72 hours and 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Remarks:
- 0.1 ml
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- 0.1 ml: severe corneal injury, iritis, severe conjunctival irritation and necrosis of the conjunctivae within 1 hour. Because of the severe, possibly irreversible, irritation at 7 days all animals were sacrificed. See table 1.
0.005 ml: minor to severe corneal injury with necrosis of the conjunctivae within 1 hour. Two of six had recovered at 7 days and only 2 showed clear effects at 14 and 21 days. See table 2. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- A reliable study, conducted largely according to OECD 405, but not GLP, reported severe eye irritation with necrosis in rabbits. The study was terminated for humane reasons at 7 days, when clear effects were still evident in all six animals.
Reference
Table 1: Irritant/corrosive response data, mean for 6 animals, dose 0.1 ml
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Discharge |
||
Opacity Max. score: 4 |
Area involved Max. score 4 |
Congestion/swelling Max. score: 2 |
Redness Max. score: 3 |
Chemosis Max. score: 4 |
Discharge Max. score: 3 |
||
1 h |
2.7 |
3.3 |
*1 |
2.0 |
1.7 |
3.0 |
|
4 h |
2.8 |
2.7 |
*1 |
2.0 |
2.0 |
2.0 |
|
24 h |
2.5 |
2.2 |
1.0 |
2.2 |
1.7 |
3.0 |
|
48 h |
2.8 |
2.2 |
1.0 |
2.3 |
1.5 |
2.8 |
|
72 h |
3.0 |
2.5 |
*1 |
2.3 |
1.7 |
2.7 |
|
7 days |
3.7 |
3.7 |
* |
1.5 |
1.2 |
1.7 |
|
Mean for 24, 48, 72 h |
2.8 |
* |
2.3 |
1.6 |
|||
Reversibility |
Considered possibly irreversible |
||||||
* scoring not possible for 1 or more animals, mean for the remainder is given
Table 2: Irritant/corrosive response data, mean for 6 animals, dose 0.005 ml (data from selected time intervals are presented here)
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Discharge |
|
Opacity Max. score: 4 |
Area involved Max. score 4 |
Congestion/swelling Max. score: 2 |
Redness Max. score: 3 |
Chemosis Max. score: 4 |
Discharge Max. score: 3 |
|
1 h |
1.7 |
2.2 |
1.0 |
2.0 |
1.3 |
2.7 |
24 h |
1.5 |
2.0 |
1.0 |
2.0 |
1.0 |
2.3 |
48 h |
1.5 |
2.2 |
1.0 |
2.0 |
1.0 |
2.0 |
72 h |
1.0 |
1.8 |
1.0 |
1.5 |
0.7 |
1.2 |
7 days |
1.2 |
1.7 |
0.5 |
0.7 |
0 |
0.7 |
21 days |
0.6 |
0.6 |
0 |
0 |
0 |
0 |
Reversibility |
Not fully reversible within 21 days |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The key study for skin irritation, conducted according to a protocol similar to OECD Test Guideline 404, but without information about GLP compliance,found the neat test material to be corrosive following occluded contact for 1 hour, and a minor to moderate irritant when in contact for 3 minutes (BRRC, 1990). A supporting study, conducted according to a protocol similar to OECD Test Guideline 404 but not in compliance with GLP, found the neat test material to be corrosive when in occluded contact with skin for 4 hours (BRRC, 1989). Several other reliable supporting studies were also available reporting irritant or corrosive effects, including BRRC (1981), Dow Corning Corporation (1976) and BRRC (1982). Reliability 4 reports (Hazelton Laboratories, 1985, BRRC, 1985) support the data set. Additionally, a non-standard study identified concentration-related dermal irritation following 9 separate 6-hour applications over 11 days. At the lowest concentration of 1 %, irritation was evident (BRRC, 1990). Further supporting evidence for the corrosive or irritation potential of the test substance is provided in a brief review of a limited study that reported moderate necrosis following 24 hours when an unspecified amount of application of the neat material had been applied to the skin of rabbit (Dow Corning Corporation, 1958) as well as in another brief review which used an unstated “short-term” contact with the neat material. Moderate irritation and scarring were observed when repeated and/or prolonged contact had occurred (Dow Corning Corporation, 1976).
The key eye irritation study which was conducted according to a standard guideline but without information on GLP compliance, observed that the neat test material was highly irritating to rabbit eyes (BRRC, 1989). Particularly, severe irritation and necrosis were evident, and all animals were sacrificed on day 7 for animal welfare reasons. The supporting studies for eye irritation are in agreement with the key findings (Mellon Institute, 1964, Mellon Institute, 1960, Dow Corning Corporation, 1976, Toxigenics, 1981, Dow Corning Corporation, 1958, Dow Corning Corporation, 1976).
Justification for classification or non-classification
Based on the available data 3-aminopropyl(triethoxy)silane requires classification for skin corrosion Cat 1B and irreversible eye damage Cat 1, H314: "causes severe skin burns and eye damage" according to Regulation (EC) No. 1272/2008.
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