Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 213-926-7 | CAS number: 1067-25-0
- 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
Skin irritation (OECD 404): irritating
Eye irritation (OECD 405): not irritating
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
- Study period:
- 5 - 19 May 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- minor deviations: coverage occlusive; limited information on test material (e.g. no data on purity or batch no.)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: White Russian (albino)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Asta-Werke AG, Bielefeld, GERMANY
- Age at study initiation: 6 months
- Weight at study initiation: 2.3-2.8 kg
- Housing: 1/cage
- Diet: standard ad libitum
- Water: drinking water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 15
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: 1987-05-05 To: 1987-05-19 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml
- Concentration: neat (100%) - Duration of treatment / exposure:
- 4 h
- Observation period:
- Examination 1, 24, 48, 72 h following removal of patch. Further observation up to 14 days.
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: gauze patch, synthetic foil cover, occlusive wrap
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: Scaling to the end of the observation period
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: Scaling to the end of the observation period
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: Scaling to the end of the observation period
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- Clear defined erythema and slight edema in all three animals. Scaling to the end of the observation period (14 days).
- Interpretation of results:
- other: CLP/EU GHS criteria are met, Category 2 (irritant) classification required according to Regulations (EC) No. 1272/2008
- Conclusions:
- In a skin irritation study conducted largely in accordance with OECD 404, but without GLP status (reliability score 2), trimethoxy(propyl)silane was irritating to the skin of rabbits.
Reference
Table 1: Irritant/corrosive response data for each animal at each observation time
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
1 h |
1,0,0 |
1,0,1 |
24 h |
2,2,2 |
2,2,2 |
48 h |
2,1,2 |
2,2,2 |
72 h |
2,2,1 |
2,2,2 |
Average 1h, 24h, 48h, 72h |
1.42 |
1.67 |
Irritation index (1h, 24h, 48h, 72h) |
3.1 |
|
Individual mean scores (24h, 48h, 72h) |
2/1.67/1.67 |
2/2/2 |
Erythema or oedema were seen for up to 8 days, scaling continued to study termination at 14 days. (Limited information appear to be presented on observations post-72h.)
No systemic toxicity was reported.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 - 12 May 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 1981
- Deviations:
- yes
- Remarks:
- incomplete details on the identity and purity of the test substance.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Albino White Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Asta-Werke AG, Bielefeld, GERMANY
- Age at study initiation: 6 months
- Weight at study initiation: 2.0-2.4 kg
- Housing: individually in stainless-steel cages (Model: ASTA)
- Diet: Sniff standard diet for rabbits, but no indication of whether it was ad libitum
- Water: Ad libitum
- Acclimation period: at least one day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 2
- Humidity (%): 55 +/-15
- Photoperiod (hrs dark / hrs light): 12/12
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration: n/a - neat - Duration of treatment / exposure:
- Single application without washing
- Observation period (in vivo):
- 6 days
Reading time points: 1, 24, 48 and 72 h and then once daily until Day 6 (scores for Days 4-6 are not given in the report) - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- Irritation index of 10.4 (out of a total possible of 110) was judged, in the report, to fall within the range 0-10 indicating no irritation.
- Other effects:
- No systemic toxicity was detected.
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- A reliable eye irritation study, conducted according to OECD 405 but not GLP, reported an irritation index of 10.4 out of 110. The index was judged in the report to indicate that the test material was not irritating to the eyes of rabbits. This finding would concur with a reading according to CLP/EU GHS criteria.
Reference
Table 1: Irritant/corrosive response data for each animal at each observation time
Score at time point / Reversibility* |
Cornea |
Iris |
Conjunctivae |
|||
Opacity - Max. score 4 (a) |
Area - Max. score 4 (b) |
Max. - score 2 (c) |
Redness - Max score 3 (d) |
Chemosis - Max. score 4 (e) |
Discharge -Max. score 3 (f) |
|
60 min |
0/0/0 |
0/0/0 |
0/0/0 |
2/3/3 |
0/2/0 |
0/1/1 |
24 h |
0/1/0 |
0/4/0 |
0/1/0 |
1/3/2 |
0/2/0 |
0/1/0 |
48 h |
0/1/0 |
0/4/0 |
0/0/0 |
0/3/2 |
0/1/0 |
0/0/0 |
72 h |
0/1/0 |
0/4/0 |
0/0/0 |
0/2/1 |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0.3 |
1.3 |
0.1 |
1.6 |
0.3 |
0.1 |
Mean scores (3 animals; 4 time points) out of maximum possible |
5/80 |
0.4/10 |
5/20 |
|||
Total score (irritation index)** (max 110) |
10.4/110 |
*Each entry shows values for each of the 3 animals
**Maximum total score irritation index = ([axbx5] + [cx5] + [(d+e+f)x2])/18
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Studies were chosen as key when the available study was of relevance and of sufficient quality for classification, labelling and for risk assessment.
There are two reliability score 2 studies available for both skin and eye irritation. Therefore, the most recent of the studies were selected as the key studies. For eye irritation, the second study supported the findings of the key study. For skin irritation the supporting study gave a result of not irritating, and was therefore not in agreement with the key study. However, this study appeared (based on translation of the German report) to be limited in its reporting of observations after 72 hours.
Skin Irritation
In the available key study trimethoxy(propyl)silane (CAS 1067-25-0) was tested for skin irritation according to the OECD 404, but not to GLP (ASTA-WERKE, 1987). 0.5 mL of the test item was applied to the shaved, intact skin of three White Russian rabbits and was covered using an occlusive dressing for four hours. Examinations of the skin were made 1, 24, 48 and 72 h after patch removal. Further observations were made at 14 days. Mean erythema scores (24/48/72 h) were 1.67 in two animals and 2 in the third animal, mean oedema scores were 2 for each animal. Erythema and oedema were seen for up to 8 days and scaling continued to study termination at 14 days. No systemic toxicity was reported. Overall, trimethoxy(propyl)silane was concluded to be irritating to the skin of rabbits.
An additional skin irritation study was conducted according to Federal Register (1973). 38, 187 (1500.41 - skin), the study pre-dates the OECD test guidelines and GLP (INBIFO, 1979). Six New Zealand White rabbits were exposed to the test item for 24 hours on intact and abraded skin. Erythema and oedema were graded at 24 and 72 h following treatment. The test item was found to be non-irritating to the skin of rabbits.
Eye Irritation
In the available key study trimethoxy(propyl)silane (CAS 1067-25-0) was tested for eye irritation according to the OECD 405, but not to GLP (ASTA-WERKE, 1987). 0.1 mL of the unchanged test item was instilled into the eyes of three Albino White Russian rabbits. Redness of the conjunctivae was the most prominent effect. It was seen in all three animals to a varying degree (score: 0.33 - 2.67, mean over 24, 48 and 72 h). All effects were reversible within six days of treatment. Overall, the scores in the report indicate that trimethoxy(propyl)silane does not warrant classification for eye irritancy.
An additional eye irritation study was conducted according to Federal Register (1973). 38, 187, (1500.42 - eye), the study pre-dates the OECD test guidelines and GLP (INBIFO, 1979). The test item was instilled into the eyes of six New Zealand White rabbits, signs of irritation were graded at 24, 48 and 72 hours post application. The test item was found to be non-irritating to eyes of rabbits.
Justification for classification or non-classification
The available data on eye irritation of the registered substance do not meet the criteria for classification according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification. The available data on skin irritation of the test substance meet the criteria for classification as Skin Irrit. 2 (H315) according to Regulation (EC) No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.