Registration Dossier
Registration Dossier
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: 200-888-1 | CAS number: 75-64-9
- 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

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18.03-10.06.1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no necropsy was performed
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- tert-butylamine
- EC Number:
- 200-888-1
- EC Name:
- tert-butylamine
- Cas Number:
- 75-64-9
- Molecular formula:
- C4H11N
- IUPAC Name:
- 2-methylpropan-2-amine
- Details on test material:
- - Name of test material (as cited in study report): t-Butylamine, ZST-No. 92/18
- Physical state: liquid, colourless
- Analytical purity: 99.9 %
- Expiration date of substance: November 1993
- Stability under test conditions: 2-10°C, under N2
- Storage condition of test material:
- Other:
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd .CH-4414 Füllinsdorf
- Age at study initiation: 13 weeks
- Weight at study initiation: male : 2.7 kg; females : 2.6 - 2.7 kg
- Housing: Individually in stainless steel cages (size : 86 x 54 x 33 cm) equipped with feed hoppers and drinking water bottles.
- Diet: Pelleted standard Kliba 341, Batch 66/91 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum .
- Water: Community tap water from Füllinsdorf, ad libitum .
- Acclimation period: days under test conditions after veterinary examination .
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 3 min
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
Approximately 24 hours before treatment, the dorsal fur was clipped with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm). The skin of the animals was examined once, 1 day prior to test article administration.
Only those animals with no signs of skin injury or irritation were used in the test.
On test day 1, 0.5 ml of the test article was applied to approx. 6 cm² of the intact skin of the clipped area. It was covered with a 3 .0 cm x 3 .0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage. The duration of treatment was 3 minutes. Then the dressing was removed and the skin was flushed with lukewarm-tap water to remove excess test article.
Prior to test article application the animals were sedated with an intramuscular injection of XYLAPAN (0 .25 ml/kg) for ethical reason.
SCORING SYSTEM:
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet redness) to slight eschar formation (injuries in depth)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritant / corrosive response data:
- Irritation:
t-Butylamine showed a primary irritation score of 4 .0 (max . 8 .0 erythema/edema scoring) when applied to healthy intact rabbit skin . Local signs (mean values from 3 minutes to 72 hours) consisted of grade 3.7 erythema and grade 0.4 edema. They were not reversible until day of experimental termination.
Corrosion:
Starting within 1 hour after the 3 minutes treatment necroses with full skin thickness destructions were observed. These effects increased until the 24 hour observation were additionally 1 out of 3 animals showed fissures. The necroses described were well movable and the edges protruded. No effect of recovery of local findings was observed during the 72 hours observation period.
Any other information on results incl. tables
Clinical signs and mortality:
No systemic symptoms were observed in the animals during the test and observation period, and no mortality occurred.
Body weight:
The body weight gain of all rabbits was with the normal range of variability.
Detailled skin irritation and corrosion data:
Animal No. 1, MALE
After 3 minutes: Application area: moderate to severe erythema, whole area treated.
After 1 hour: Application area: moderate to severe erythema, whole area treated; necroses observed.
After 4 hours: Application area: severe erythema (beet redness) to slight eschar formations (injury in-depth); necroses observed; necroses hardened and therefore well movable.
After 24 hours: Application area: severe erythema (beet redness) to slight eschar formations (injury in-depth); necroses observed; necroses hardened an d therefore well movable.
After 48 hours: Application area: severe erythema (beet redness) to slight eschar formations (injury in-depth); necroses observed; necroses hardened and therefore well movable.
After 72 hours: Application area: severe erythema (beet redness) to slight eschar formations (injury in-depth); necroses observed; hardened, well movable; edges of the necroses protruded.
Animal No. 2, FEMALE
After 3 minutes: Application area: moderate to severe erythema, whole area treated; very slight edema whole area treated.
After 1 hour: Application area: moderate to severe erythema, whole area treated; very slight edema whole area treated; necroses observed.
After 4 hours: Application area: severe erythema (beet redness) to slight eschar formation (injury in depth); necroses with crusts, slightly hardened and movable; slight edema, edges of area well defined by definite rising. After 24 hours: Application area: severe erythema (beet redness) to slight eschar formation (injury in depth); necroses, size: 2 x 0.5 cm, slightly hardened and movable .
After 48 hours: Application area: severe erythema ( beet redness) to slight eschar formation (injury in depth); necroses, size: 2 x 0.5 cm, slightly hardened and movable, edges of the necroses protruded.
After 72 hours: Application area: severe erythema ( beet redness) to slight eschar formation (injury in depth); necroses, size: 2 x 0 .5 cm, slightly hardened and movable, edges of the necroses protruded.
Animal No. 3, FEMALE
After 3 minutes: Application area: moderate to severe erythema, whole area treated; moderate edema (raised approx. 1 mm)/whole area; necroses observed.
After 1 hour: Application area: moderate to severe erythema, whole area treated; necroses observed.
After 4 hours: Application area: severe erythema (beet redness) to slight eschar formations (injury in depth), whole area; necroses, slightly hardened and movable.
After 24 hours: Application area: severe erythema (beet redness) to slight eschar formations (injury in depth), whole area; necroses with fissures, well movable, edges protruded.
After 48 hours: Application area: severe erythema (beet redness) to slight eschar formations (injury in depth), whole area; necroses with fissures, well movable, edges protruded.
After 72 hours: Application area: severe erythema (beet redness) to slight eschar formations (injury in depth), whole area; necroses with fissures, well movable, edges protruded.
Readings |
Animal |
Exposure period:3min |
||
Erythema |
Edema |
Additional findings |
||
3 min |
1 |
3 |
0 |
|
2 |
3 |
1 |
|
|
3 |
3 |
3 |
|
|
1 h |
1 |
3 |
0 |
|
2 |
3 |
1 |
|
|
3 |
3 |
0 |
|
|
4 h |
1 |
4 |
0 |
|
2 |
4 |
2 |
|
|
3 |
4 |
0 |
|
|
24 h |
1 |
4 |
0 |
|
2 |
4 |
0 |
|
|
3 |
4 |
0 |
|
|
48 h |
1 |
4 |
0 |
|
2 |
4 |
0 |
|
|
3 |
4 |
0 |
|
|
72 h |
1 |
4 |
0 |
|
2 |
4 |
0 |
|
|
3 |
4 |
0 |
|
|
Mean 24, 48, 72 h |
1 |
4 |
0 |
|
2 |
4 |
0 |
|
|
3 |
4 |
0 |
|
|
Mean 24, 48, 72 h |
1-3 |
4 |
0 |
|
Applicant's summary and conclusion
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.
