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EC number: 203-818-8 | CAS number: 110-95-2
- 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
N, N, N', N'-tetramethyltrimethylenediamine (TMDAP) is corrosive to the skin and the eyes and irritating to the respiratory tract.
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:
- other: Comparable to guideline study with acceptable restrictions (occlusive treatment)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (limited documentation, occlusive treatment)
- Principles of method if other than guideline:
- Method: BASF-Test
Three animals were treated for 3 min and 1 h using occlusive conditions. The application site of 2.5 x 2.5 cm (flanks) was covered with the liquid test substance. After exposure the skin was washed with Lutrol (conc.) and Lutrol/water (1:1). The animals were observed for 8 days and skin changes were recorded after patch removal, 24 h, 48 h and 8 days after application. The test is comparable to the initial test descirbed in the OECD guideline 404 to evaluate the corrosive potential of a test substance. - GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Firma Gaukler; Offenbach Germany
- Weight at study initiation: 3.07 kg (mean)
- Housing: one per cage
- Diet: Ovator Solikanin 4 mm; Muskator-Werke Duesseldorf; ad libitum
- Water: FulIy demineralized water ad libitum each workday; tap water ad libitum on public holidays.
- Acclimation period: ca. 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.5 mL - Duration of treatment / exposure:
- 3 min (right flank) and 1 h (left flank)
- Observation period:
- 8 days
- Number of animals:
- 1 male and 2 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol (conc.) and Lutrol/water (1:1)
- Time after start of exposure: 3 min or 1 h
EVALUATION: according to the Draize Scoring System - Irritation parameter:
- other: corrosion
- Basis:
- mean
- Remarks:
- (3 animals, 3 min exposure)
- Remarks on result:
- other: Non-reversible necroses (superficial) were observed in all animals.
- Irritation parameter:
- other: corrosion
- Basis:
- mean
- Remarks:
- (3 animals, 1 h exposure)
- Remarks on result:
- other: Non-reversible, full thickness necroses were observed in all animals.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (3 min exposure)
- Time point:
- other: 24 h - 48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (3 min exposure)
- Time point:
- other: 24 h - 48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (3 min exposure)
- Time point:
- other: 24 h - 48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (1 h exposure)
- Time point:
- other: 24 h - 48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (1 h exposure)
- Time point:
- other: 24 h - 48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (1 h exposure)
- Time point:
- other: 24 h - 48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (3 min exposure)
- Time point:
- other: 24 h - 48 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (3 min exposure)
- Time point:
- other: 24 h - 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (3 min exposure)
- Time point:
- other: 24 h - 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (1 h exposure)
- Time point:
- other: 24 h - 48 h
- Score:
- 3.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (1 h exposure)
- Time point:
- other: 24 h - 48 h
- Score:
- 3.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (1 h exposure)
- Time point:
- other: 24 h - 48 h
- Score:
- 3.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Interpretation of results:
- Category 1B (corrosive)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
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:
- other: Comparable to guideline study with acceptable restrictions (limited documentation on test substance and test animals)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (application amount, limited documentation, 2 animals)
- Principles of method if other than guideline:
- 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 h and 3 h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.03 kg and 3.24 kg (males) - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The adjacent eye served as saline control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 µL - Duration of treatment / exposure:
- Single application, no rinsing
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (2 animals)
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- other: conjunctivae score of 2 in animal#2 on day 8.
- Irritant / corrosive response data:
- 1 h post application: nictitating membrane and mucosae reddish-brown, discharge of blood.
24 h post application: nictitating membrane grey, mucosae reddish-brown, margins of eyelid necrotic.
8 days post application: nictitating membrane grey, mucosae grey, margins of eyelid necrotic, beginning staphyloma. - Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Findings animal1:
Time |
Opacity |
Chemosis |
Erythema |
Iris |
1h |
3 |
3 |
0 |
0 |
24h |
3 |
3 |
0 |
0 |
48h |
3 |
3 |
0 |
0 |
72h |
3 |
3 |
0 |
2 |
8d |
3 |
3 |
0 |
2 |
Findings animal2:
Time |
Opacity |
Chemosis |
Erythema |
Iris |
1h |
3 |
3 |
0 |
0 |
24h |
3 |
3 |
0 |
0 |
48h |
3 |
3 |
0 |
0 |
72h |
3 |
3 |
0 |
0 |
8d |
3 |
3 |
2 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin Irritation-Corrosion
In vitro studies
To evaluate the potential skin corrosivity of N, N, N', N'-tetramethyltrimethylenediamine, the pH and acidic/alkaline reserve was measured according to the method described by Regnier and Imbert (ATLA, 1992, 20, 457-465) and Froment (Arkema unpublished data, 1993). Under the test conditions, the results are as follow:
Test item |
pH | log R (acidic/alkaline reserve |
Physical-chemical index (I) I = pH + log R, for pH ≥7 I = (14 -pH) + log R, for pH < 7 | |
N, N, N', N'-tetramethyltrimethylenediamine |
11.2 |
1.6 |
12.8 |
According to the method, a substance is considered as potentially corrosive to the skin if at least 2 of the 3 following criteria are fulfilled:
pH≤ 2.5 or pH ≥9.5; log R ≥ 0 and/ot I≥ 10.
N, N, N', N'-tetramethyltrimethylenediamine is considered as potentially corrosive to the skin.
In vivo studies
In a BASF study (BASF 1982), three animals were treated for 3 min or 1 h with N, N, N', N'-tetramethyltrimethylenediamine using occlusive conditions. At the end of the observation period after 8 days deep necrosis and spanning edema exiciting the application site (1 h exposure) were found
The acute dermal irritation of N, N, N', N'-tetramethyltrimethylenediamine (TMPDA) was evaluated in one malealbino rabbit according to OECD N°404 Guideline (Clouzeau, 1988). 0,5mL of TMPDA was held in contact with the skin for 4 hours by a semi-occlusive dressing. The cutaneous reactions were observed one hour, 24, 48 and 72 hours after the removal of the dressing. After application of the substance during 4 hours, tissular destruction on the whole depth of the skin was observed in the three animals, which were sacrificed for ethical reasons.
Under these experimental conditions, TMPDA has to be classified as corrosive.
Eye irritation-Corrosion
In vitro studies
To evaluate the potential skin corrosivity of N, N, N', N'-tetramethyltrimethylenediamine, the pH and acidic/alkaline reserve was measured according to the method described by Regnier and Imbert (ATLA, 1992, 20, 457-465) and Froment (Arkema unpublished data, 1993). Under the test conditions, the results are as follow:
Test item |
pH | log R (acidic/alkaline reserve |
Physical-chemical index (I) I = pH + log R, for pH ≥7 I = (14 -pH) + log R, for pH < 7 | ||
N, N, N', N'-tetramethyltrimethylenediamine |
11.2 |
1.6 |
12.8 |
According to the method, a substance is considered as potentially corrosive to the eye if at least 2 of the 3 following criteria are fulfilled:
pH≤ 2.5 or pH ≥9.5; log R ≥ 0 and /or I≥ 9.
N, N, N', N'-tetramethyltrimethylenediamine is considered as potentially severely irritating to the eye.
In vivo studies
In a BASF study (BASF 1974), 50 µl of N, N, N', N'-tetramethyltrimethylenediamine was applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. A corneal score of 3 (max score 4) and a chemosis score of 2 (max score 4) were calculated. N, N, N', N'-tetramethyltrimethylenediamine was considered as corrosive to the eye.
Respiratory tract
Clinical signs of respiratory tract irritation were observed in an acute inhalation toxicity study in rats (BASF, 1974).
Justification for selection of skin irritation / corrosion endpoint:
Key study
Justification for selection of eye irritation endpoint:
Key study
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: corrosive
Effects on respiratory irritation: irritating
Justification for classification or non-classification
Skin irritation:
N, N, N', N'-tetramethyltrimethylenediamine induced skin corrosion after a 1 -hour exposure. On this basis and in accordance with Regulation (EC) No 1272/2008, N, N, N', N'-tetramethyltrimethylenediamine was classified as corrosive category 1B (Hazard statment H314: Causes severe skin burnsand eye damage) and in accordance with Annex VI of Commission Directive 2001/59/EC, N, N, N', N'-tetramethyltrimethylenediamine was classified as corrosive with the symbol C and the phrase R34 "Causes burns".
Eye irritation:
N, N, N', N'-tetramethyltrimethylenediamine is classified as corrosive to the skin. On this basis and in accordance with Regulation (EC) No 1272/2008 N, N, N', N'-tetramethyltrimethylenediamine was classified as irritating to eyes caregory 1 (H318: Causes serious eye damage).
Respiratory tract irritation:
In acute inhalation exposure studies, N, N, N', N'-tetramethyltrimethylenediamine induced respiratory tract irritation. On this basis and in accordance with Regulation (EC) No 1272/2008, N, N, N', N'-tetramethyltrimethylenediamine was classified as Specific Target Organ Toxicity (STOT) Single Exposure (SE) Category 3 and in accordance with Annex VI of Commission Directive 2001/59/EC, N, N, N', N'-tetramethyltrimethylenediamine was classified as irritant with the symbol Xi and the phrase R37 "irritating to the respiratory tract".
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