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Diss Factsheets
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EC number: 250-437-8 | CAS number: 31024-56-3
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 Nov - 12 Dec 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP study conducted according to the appropriate OECD test guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (1981)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- N-methyl-3-(trimethoxysilyl)propylamine
- EC Number:
- 221-334-5
- EC Name:
- N-methyl-3-(trimethoxysilyl)propylamine
- Cas Number:
- 3069-25-8
- IUPAC Name:
- N-Methyl-3-(trimethoxysilyl)-1-propanamine
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: White Russian (Chbb)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Carl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2100 - 2300 g
- Housing: Animals were housed individually in stainless steel cages
- Diet: K4 diet for rabbits (Ssniff Spezialfutter GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 21 days
Reading time points: 1, 24, 48 and 72 h and 6, 8, 10, 14, 17 and 21 days - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: dorsal/lateral trunk
- Type of wrap if used: The exposure area (6 cm²) was covered with elastic gauze.
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed using warm water after the exposure period.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 days
- Remarks on result:
- other: no eschar formation observed
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: eschar formation after 72 h, fully reversible within 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: eschar formation after 72 h with detachment within 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritant / corrosive response data:
- Well-defined erythema (grade 2 in 3/3 animals) and edema (grade 1 in 2/3 animals, grade 2 in 1/3 animals) formation was observed in 3/3 animals 1 h after removal of the test material. Moderate to severe erythema (grade 3) formation was observed in the first animal 24 h after removal of the test material but was fully reversible within 17 days. Slight edema (grade 2) formation was observed 24 h after removal of the test material in the same animal, being fully reversible within 6 days. Very slight erythema (grade 1) formation was still recorded in the second animal within 24 h, but was fully reversible within 6 days (including slight eschar formation after 72 h). Very slight edema (grade 1) formation persisted 24 h after removal of the test material and was fully reversible within 48 h. The third animal showed well--defined erythema (grade 2) formation until 72 h after removal of the test material including slight eschar formation after 72 h. Erythema and eschar formation were fully reversible within 8 and 10 days, respectively. Moderate to severe edema (grade 3) formation was observed at the 24 h reading time point but was fully reversible within 6 days.
- Other effects:
- No symptoms of systemic toxicity were observed in any animal during the test period and no mortality occurred during the course of the study.
Any other information on results incl. tables
Table 1: Summary of individual skin reaction
Observation time |
Rabbit no. |
|||||
1 |
2 |
3 |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
24 h |
3 |
2 |
1 |
1 |
2 |
3 |
48 h |
3 |
2 |
1 |
0 |
2 |
2 |
72 h |
2 |
2 |
1 |
0 |
2 |
1 |
Mean value 24 + 48 + 72 h |
2.67 |
2 |
1 |
0.33 |
2 |
2 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- The test item was tested for skin irritation/corrosion according to the OECD TG 404, but not in compliance with GLP. The undiluted test material was semiocclusively applied to the trunk of 3 male rabbits for 4 h. 1, 24, 48, and 72 h, as well as 6, 8, 10, 13, 17, and 21 days after removal of the test item the skin reactions were recorded. Mean erythema scores over 24, 48, and 72 h noted were 2.67, 1,and 2, respectively, and mean oedema scores were 2, 0.3, and 2, respectively. In one animal showing the strongest erythema reaction, the effect was reversible within 17 days. Hence, the test material was considered to be not irritating to the skin according to CLP/EU GHS criteria but meets the classification as Category 3 based on GHS criteria.
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