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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From March 2, 2010 to March 5, 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Version / remarks:
adopted 13 April 2004
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Identification: Dodecyldipropylenetriamine
Chemical name: N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine
Molecular formula: C18H41N3
Molecular weight: 299.54
Description: Hazy colourless liquid (determined at NOTOX)
Batch: S-001148
Purity: 90.9%
Test substance storage: At room temperature in the dark under nitrogen
Stability under storage conditions: Stable
Expiry date: 04 February 2018

Study specific test substance information:
Test substance handling: When the appearance is becoming cloudy, it might have been cooled for some time. In that case it is best to warm the sample (under nitrogen or in closed bottle) up to about 50 °C, until it is clear again. Draw a sample form the clear solution.

Stability at higher temperatures: Yes, maximum temperature 250°C
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Justification for test system used:
Recommended test system in international guidelines (OECD and EC)
Vehicle:
water
Details on test system:
Test system
EpiDerm Skin Model (EPI-200, Lot no.: 12935 kit H): The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm tissues (surface 0.6 cm²) were cultured on polycarbonate membranes of 10 mm cell culture inserts.

Source:
MatTek Corporation, Ashland MA, U.S.A.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
Undiluted (50 μl) directly on top of the tissue
Duration of treatment / exposure:
3 minutes and 1 h
Number of replicates:
2 for a 3 minute and 1 h exposure to test substance
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 min exposure
Value:
43
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1 h exposure
Value:
42
Negative controls validity:
valid
Positive controls validity:
valid

Test substance was checked for possible direct MTT reduction by adding the test substance to MTT medium. Because a colour change was observed it was concluded that test substance did interact with MTT. In addition to the normal 1-hour procedure, one freeze-killed tissue treated with test substance and one freeze-killed non treated tissue was used for the cytotoxicity evaluation with MTT. The non-specific reduction of MTT by test substance was 4.72% of the negative control tissues. The net OD of the treated freeze-killed tissues was subtracted from the ODs of the test substance treated viable tissues. The mean absorption at 540 nm measured after treatment with test substance and controls are presented in Table 1. The individual OD540 measurements are presented in Appendix I. Table 2 shows the mean tissue viability obtained after 3-minute and 1-hour treatments with test substance compared to the negative control tissues. Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after the 3-minute and 1-hour treatments with test substance compared to the negative control tissues was 43% and 42% respectively.

Table 1: Mean absorption in the in vitro skin corrosion test with test substance

3 minute application

 

 

1 hour application

 

 

A

(OD540)

B

(OD540)

Mean

(OD540)

SD

A

(OD540)

B

(OD540)

Mean

(OD540)

SD

Negative control

1.683

1.699

1.691

±0.011

1.707

1.710

1.708

±0.002

Dodecyldipropyl enetriamine

0.702

0.736

0.719

±0.025

0.721

0.716

0.719

±0.004

Positive control

0.150

0.143

0.147

±0.005

0.148

0.145

0.147

±0.002

SD = Standard deviation

Duplicate exposures are indicated by A and B.

(1) The values are corrected for the non-specific MTT reaction.

In this table the values are corrected for background absorption. Isopropanol was used to measure the background absorption

Table 2: Mean tissue viability in the in vitro skin corrosion test with Dodecyldipropylenetriamine

3 minute application viability

(% of control)

1 h application viability

(% of control)

Negative control

100

100

Dodecyldipropyl enetriamine

43

42

Positive control

9

9

APPENDIX I: Individual OD measurements at 540 NM

3 minute application

(OD540)

1 hour application

(OD540)

1 hour application freeze killed

(OD540)

A

B

A

B

treated

non-treated

Negative control

(OD540)

measurement 1

1.686

1.686

1.704

1.713

(OD540)

measurement 2

1.694

1.703

1.709

1.714

(OD540)

measurement 3

1.670

1.709

1.708

1.702

Dodecyldipropyl enetriamine

(OD540)

measurement 1

0.789

0.815

0.820

0.796

0.453

0.373

(OD540)

measurement 2

0.779

0.815

0.794

0.798

0.446

0.368

(OD540)

measurement 3

0.779

0.815

0.792

0.797

0.444

0.360

Positive control

(OD540)

measurement 1

0.155

0.144

0.149

0.146

(OD540)

measurement 2

0.149

0.143

0.148

0.144

(OD540)

measurement 3

0.146

0.142

0.147

0.145

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
Under the study conditions, the test substance was identified as corrosive to skin.
Executive summary:

A study was conducted to determine the skin corrosive property of the test substance (90.9% purity)in vitroaccording to OECD Guideline 431, in compliance with GLP. The test substance was applied undiluted (50 μL) directly on top of the skin tissue. Test substance did interact with 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT). In addition to the normal 1 h procedure, one freeze-killed tissue treated with test substance and one freeze-killed non treated tissue was used for the cytotoxicity evaluation with MTT. The non-specific reduction of MTT by test substance was 4.72% of the negative control tissues. The net OD of the treated freeze-killed tissues was subtracted from the ODs of the test substance treated viable tissues. Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 3 min and 1 h treatments with test substance compared to the negative control tissues was 43 and 42%, respectively. Because the mean relative tissue viability for test substance was below 50% after the 3 min treatment, it was considered to be corrosive. Under the study conditions, the test substance was identified as corrosive to skin (Buskens, 2010).

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
3 minutes
Observation period:
14 days
Number of animals:
3
Irritation parameter:
overall irritation score
Basis:
other: All animals
Time point:
other: 1 hour
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Well-defined erythema and moderate oedema were noted at all treated skin sites after the one-hour observation. Haemorrhage of the dermal capillaries at two treatment sites and blanching of the skin were noted at one treatment site a well.
Interpretation of results:
corrosive
Conclusions:
Under the study conditions, the test substance was considered corrosive to rabbit skin.
Executive summary:

A study was conducted to determine the in vivo skin irritation potential of the test substance to New Zealand White rabbit skin according to EU Method B.4, in compliance with GLP. Three animals were treated with unchanged test substance for 3 min and observations were made after 1 h. Well-defined erythema and moderate oedema were noted at all treated skin sites after the 1 h observation. Haemorrhage of the dermal capillaries at two treatment sites and blanching of the skin were noted at one treatment site as well. Under the study conditions, the test substance was considered corrosive to rabbit skin (Allen, 1994).

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From January 15, 2002 to April 17, 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France
- Weight at study initiation: 2.9 kg
- Housing: In a polystyrene cage (48.2 x 58 x 36.5 cm)
- Diet: 110 pelleted diet (UAR, Villemoisson, Epinay-sur-Orge, France)
- Water: Ad libitum
- Acclimation period: At least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin served as control
Amount / concentration applied:
TEST SUBSTANCE
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Undiluted
Duration of treatment / exposure:
3 minutes to the left flank; 4 h to the right flank.
Observation period:
After a 3-minute exposure: The animals were examined after 60 min and 24 h after removal of the dressing
After a 4-h exposure: The animals were examined after 60 min and 20 h after removal of the dressing
Number of animals:
1 male
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance was wiped off by means of a dry gauze pad.
- Time after start of exposure: 3 minutes or 4 h.

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 h (after 3 min exposure)
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: At the 24 h time point, necrosis of the whole treatment site was noted.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 h (after 3 min exposure)
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: At the 24 h time point, necrosis of the whole treatment site was noted.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 h (after 4 h exposure)
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: A brownish coloration of the treatment site, which could have masked a moderate to severe erythema was noted. Moreover, at the 20 h time point, necrosis of the whole treatment site was noted.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 h (after 4 h exposure)
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: A brownish coloration of the treatment site, which could have masked a severe edema was noted. Moreover, at the 20 h time point, necrosis of the whole treatment site was noted.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
After a 3-minute exposure:
- At the 1-h reading, a moderate to severe erythema (3) associated with a slight oedema (2), was observed.
- At the 24-h reading, necrosis on the whole treatment site was noted.

After a 4-h exposure:
- At the 1-h reading, A brownish coloration of the treatment site, which could have masked a moderate to severe erythema (3) and associated with a severe oedema (4) was recorded.
- At the 20-h reading (this treatment site was also observed during the 24-h reading, after a 3-minute application), necrosis was recorded on the whole treatment site. Due to the severity of the cutaneous reactions observed, the study was stopped and the animal was killed for humane reasons.
Interpretation of results:
Category 1B (corrosive)
Conclusions:
Under the study conditions, the test substance was considered to be corrosive to skin.
Executive summary:

A study was conducted to determine the irritation/corrosion potential of the test substance to New Zealand White rabbits according to OECD Guideline 404 and EU Method B.4, in compliance with GLP. 0.5 mL of the undiluted test substance was applied to the clipped skin of one male White rabbit under semi-occlusive dressing. The substance was applied to the left flank for 3 min and to the right flank for 4 h, followed by observation after 1 and 24 or 20 h post removal of the dressing. Very severe irritation was observed at both exposure sites 1 h after exposure and complete necrosis of the skin was seen after 20-24 h. Under the study conditions, the test substance was considered to be corrosive to rabbit skin (Pelcot, 2002).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
other justification
Justification for data waiving:
the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

A study was conducted to determine the irritation/corrosion potential of the test substance to New Zealand White rabbits according to OECD Guideline 404 and EU Method B.4, in compliance with GLP. 0.5 mL of the undiluted test substance was applied to the clipped skin of one male White rabbit under semi-occlusive dressing. The substance was applied to the left flank for 3 min and to the right flank for 4 h, followed by observation after 1 and 24 or 20 h post removal of the dressing. Very severe irritation was observed at both exposure sites 1 h after exposure and complete necrosis of the skin was seen after 20-24 h. Under the study conditions, the test substance was considered to be corrosive to rabbit skin (Pelcot, 2002).

A study was conducted to determine the in vivo skin irritation potential of the test substance to New Zealand White rabbit skin according to EU Method B.4, in compliance with GLP. Three animals were treated with unchanged test substance for 3 min and observations were made after 1 h. Well-defined erythema and moderate oedema were noted at all treated skin sites after the 1 h observation. Haemorrhage of the dermal capillaries at two treatment sites and blanching of the skin were noted at one treatment site as well. Under the study conditions, the test substance was considered corrosive to rabbit skin (Allen, 1994).

Although sufficient in vivo data pointing at clear skin corrosion was available, an additional in vitro skin corrosion study using reconstructed human epithelia was performed in a project to examine the applicability of this test system for this type of substance (i.e. surfactant). Therefore, a study was conducted to determine the skin corrosive property of the test substance (90.9% purity) in vitro according to OECD Guideline 431, in compliance with GLP. The test substance was applied undiluted (50 μL) directly on top of the skin tissue. Test substance did interact with 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT). In addition to the normal 1 h procedure, one freeze-killed tissue treated with test substance and one freeze-killed non-treated tissue was used for the cytotoxicity evaluation with MTT. The non-specific reduction of MTT by test substance was 4.72% of the negative control tissues. The net OD of the treated freeze-killed tissues was subtracted from the ODs of the test substance treated viable tissues. Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 3 min and 1 h treatments with test substance compared to the negative control tissues was 43 and 42%, respectively. Because the mean relative tissue viability for test substance was below 50% after the 3 min treatment, it was considered to be corrosive. Under the study conditions, the test substance was identified as corrosive to skin (Buskens, 2010).

Eyes

No eye irritation testing was conducted as the substance is corrosive to skin.

Justification for classification or non-classification

Skin and eyes

Based on the results of in vivo skin irritation/corrosion studies, the test substance warrants classification as Skin Corr. 1B – H314 (Causes severe burns and eye damage) according to CLP (EC 1272/2008) criteria.