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EC number: 221-329-8 | CAS number: 3068-78-8
- 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, rabbit): not irritating
Eye irritation (OECD 405, rabbit): causes irreversible effects to the eye (RA from N-methylaminopropyltrimethoxysilane, CAS 3069 -25 -8 and N-[3 -(trimethoxysilyl) propyl]butylamine, CAS 31024-56-3)
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:
- 21 - 28 Apr 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (1981)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- (1984)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: 12 weeks
- Weight at study initiation: 2198 - 2452 g
- Housing: animals were housed individually in labelled cages with perforated floors
- Diet: approximately 100 g/day standard laboratory rabbit diet LKK-20 (Hope Farms, Woerden, The Netherlands), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - 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:
- 7 days
Reading time points: 45 min, 24, 48 and 72 h and 7 days - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 2 x 3 cm
- Type of wrap if used: A surgical gauze patch mounted on Micropore tape was used, the dressing was wrapped around the abdomen and secured with an elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: 4 h after the application the dressing was removed and residual test material was removed using a tissue moistened with tap water and subsequently a dry tissue.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Forty-five minutes after exposure to the test material, very slight (grade 1) or well defined erythema (grade 2) and very slight (grade 1) or slight edema (grade 2) were observed in the treated skin areas in 3/3 animals. The erythema persisted for 72 h and had resolved in 3/3 animals within 7 days after exposure to the test material. The edema had resolved within 48 h in 2/3 animals and within 72 h in 1/3 animal after exposure with the test material. No evidence of a corrosive effect was observed on the skin.
- Other effects:
- No symptoms of systemic toxicity were observed in the animals during the study period and no mortality occurred.
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- In a primary skin irritation/corrosion study according to OECD guideline 404 and in compliance with GLP, three male New Zealand White rabbits were exposed to the test material for 4 h under semi-occlusive dressing. In conclusion, the test material can be considered as non-irritant under the conditions of the test.
Reference
Table 1: Individual skin irritation scores
Observation time |
Rabbit no. |
|||||
1 |
2 |
3 |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
45 min |
2 |
1 |
1 |
1 |
2 |
2 |
24 h |
2 |
1 |
1 |
2 |
2 |
1 |
48 h |
2 |
0 |
1 |
1 |
2 |
0 |
72 h |
1 |
0 |
1 |
0 |
1 |
0 |
Mean value 24 + 48 + 72 h |
1.67 |
0.33 |
1 |
1 |
1.67 |
0.33 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- Summary of available data used for the endpoint assessment of the target substance
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to the attached justification below and the overall justification for grouping of substances attached in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 21 days
- Remarks on result:
- other: CAS 3069-25-8, Huls AG, 1989
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 21 days
- Remarks on result:
- other: CAS 3069-25-8, Huls AG, 1989
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 21 days
- Remarks on result:
- other: CAS 3069-25-8, Huls AG, 1989
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other:
- Remarks:
- CAS 3069-25-8, Huls AG, 1989
- Irritant / corrosive response data:
- In a supporting study done with the read across substance CAS 31024-56-3 the following results were observed (Bushy Run Research Center, 1981):
The test item was tested for its eye irritating properties in a non-guideline study and without GLP compliance. Single instillation of 0.005, 0.02, 0.1, or 0.5 mL undiluted or 0.5 mL of 40, 15, 5, or 1% test material dilutions in propylene glycol were made into the conjunctival sac of 5 rabbits. Severe corneal injury with iritis from 0.05 mL undiluted test material per eye and moderate to severe corneal injury with irritis one one animal treated with 0.5 mL of 5% test material diluted in propylene glycol were oserved. No injury was observed in 5 eyes treated with 1% test material in propylene glycol. Hence, the test item was concluded to cause severe damage to the eyes. - Interpretation of results:
- other: CLP/EU GHS criteria are met, Categroy 1 (irreversible effects on the eye) classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- In two in vivo acute eye irritation/corrosion studies in rabbit with the source substances CAS 3069-25-8 and CAS 31024-56-3 showed irreversible damage to the eyes. As explained in the analogue justification, it is considered that the target and the source substances are unlikely to lead to differences in eye irritation potential.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
In the reliable skin irritation study performed with N-[3-(trimethoxysilyl)propylcyclohexylamine] (CAS 3068-78-8) according to OECD TG 404 and in compliance with GLP three male New Zealand White rabbits were exposed to 0.5 mL of the neat test material (CAS 3068-78-8) for 4 hours applied onto the shaved skin via semi-occlusive dressing (RCC, 1993). Skin reactions were evaluated according to the Draize scoring system 45 min, 24, 48 and 72 hours and 7 days post-application. No symptoms of systemic toxicity were observed in any animal during the test period and no mortality occurred during the course of the study. Forty-five minutes after exposure with the test material, very slight (grade 1) or well defined erythema (grade 2) and very slight (grade 1) or slight edema (grade 2) were observed in the treated skin areas in 3/3 animals. The erythema persisted for 72 h and had resolved in 3/3 animals within 7 days after exposure with the test material. The edema had resolved within 48 h in 2/3 animals and within 72 h in 1/3 animal after exposure with the test material. No evidence of a corrosive effect was observed on the skin. The mean values for erythema and edema were calculated to be 1.67, 1.0, 1.67 and 0.33, 1.0, 0.33, respectively.
Eye irritation
No data on the eye irritation of N-[3-(trimethoxysilyl)propylcyclohexylamine] (CAS 3068-78-8) are available. Therefore, the risk assessment was performed based on the available data from the source substances N-methyl-3-(trimethoxysilyl)propan-1-amine (CAS 3069-25-8) and N-[3-(trimethoxysilyl)propyl]butylamine (CAS 31024-56-3). In accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5 “Grouping of substances and read across” and in accordance with the Read across assessment framework (RAAF, ECHA 2017) read across from analogue substances has been applied to support the human health hazard assessment of N-[3-(trimethoxysilyl)propylcyclohexylamine] (CAS 3068-78-8). Details on read across justifications can be found in the attached justification in the respective target entry and in the overall justification for grouping of substances attached in IUCLID Section 13.
Studies were chosen as key when the available study was of relevance and of sufficient quality for classification and labelling and for risk assessment.
In the available key study (Hüls AG, 1989) conducted according to the OECD TG 405, but not in compliance with GLP, one Small White Russian rabbit was instilled with 0.1 mL of the undiluted N-methyl-3-(trimethoxysilyl)propan-1-amine (CAS 3069-25-8) into the eye. It is not stated in the study report, whether the test item was administered into both eyes or one eye remained untreated and served as control. After 1 h severe redness and chemosis of the conjunctiva, corneal opacity grade 3 and iridic irritation grade 1 were observed. Moreover, iris reaction was delayed. Similar reactions persisted after 24 h and necrosis of the nictitating membrane and the conjunctiva was observed, in addition to strongly reddened iris in combination with haemorrhage. Treatment of the eyes with fluorescein revealed opacity of an area greater than three quarters up to the whole area. The mean scores over 24, 48, and 72 h were 2, 1, 3, and 1 for cornea, iris, redness, and chemosis, respectively. Only the noted chemosis was reversible within 21 days; all other damages were still persistent at study termination. Since the measured pH value of the test item was 12.3, only one animal was tested for acute eye irritation in this study. It can be concluded that the severe eye effects could be due to the strong alkalinity of the test substance. Based on this result, N-methyl-3-(trimethoxysilyl)propan-1-amine (CAS 3069-25-8) is considered to cause irreversible effects on the eye.
In the supporting study (Bushy Run Research Center, 1981) N-[3-(trimethoxysilyl)propyl]butylamine (CAS 31024-56-3) was tested for its eye irritating properties in a non-guideline study and without GLP compliance. Single instillation of 0.005, 0.02, 0.1, or 0.5 mL undiluted or 0.5 mL of 40, 15, 5, or 1% test material dilutions in propylene glycol were made into the conjunctival sac of 5 rabbits. Severe corneal injury with iritis was noted from 0.005 mL undiluted test material per eye. In another dose group moderate to severe corneal injury with iritis was observed in one animal treated with 0.5 mL of 5% test material diluted in propylene glycol. No injury was observed in 5 eyes treated with 1% test material in propylene glycol. No individual scores were given in the study report. Hence, N-[3-(trimethoxysilyl)propyl]butylamine (CAS 31024-56-3) was concluded to cause severe damage to the eyes.
Considering the positive results in tests with structural similar substances, it is concluded that the target substance N-[3-(trimethoxysilyl)propylcyclohexylamine] (CAS 3068-78-8) has eye damaging properties as well.
Justification for classification or non-classification
The available data on skin irritation/corrosion 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.
Reliable data from a structural analogue on eye irritation indicates that the registered substance meets the criteria for classification according to Regulation (EC) 1272/2008, and is therefore classified as Eye Damaging Category 1 (H318).
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