Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 40 CFR, Subdivision F, par. 158.50 and 158.135; Section 81-5, pg. 55-59, Primary Dermal Irritation
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-{[3-(dodecylamino)propyl]amino}acetic acid; {2-[(2-aminoethyl)amino]ethyl}(dodecyl)amine
IUPAC Name:
2-{[3-(dodecylamino)propyl]amino}acetic acid; {2-[(2-aminoethyl)amino]ethyl}(dodecyl)amine
Test material form:
solid - liquid: aqueous solution

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: at least 2-3 kg
- Diet (e.g. ad libitum): rabbit diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 65-75°F
- Humidity (%): 40-60%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped; intact + abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL


Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
6
Details on study design:
OBSERVATION TIME POINTS
1, 24, 48, and 72 hours after patch removal

SCORING SYSTEM:
Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal: 1-6
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal: 1, 3, 4, 5, 6
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.33
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
All animals displayed severe blistering and eschar formation.

Any other information on results incl. tables

Score at time point

Erythema, intact skin

Erythema, abraded skin

Edema, intact skin

Edema, abraded skin

Max. score: 4

Max. score: 4

Max. score: 4

Max. score: 4

60 min

2/2/2/2/1/2

3/3/3/3/3/3

2/3/2/3/2/2

3/4/3/3/3/3

24 h

4/4/4/4/4/4

3/3/3/3/3/3

4/4/4/4/4/4

3/3/3/3/3/3

48 h

4/4/4/4/4/4

3/3/3/3/3/3

4/4/4/4/4/4

3/3/3/3/3/3

72 h

4/4/4/4/4/4

3/4/3/3/3/3

4/4/4/4/4/4

3/4/3/3/3/4

Average 24h, 48h, 72h

4/4/4/4/4/4

3/3.33/3/3/3/3

4/4/4/4/4/4

3/3.33/3/3/3/3.33

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
In this study, Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid (22.5% a.i.) was corrosive to rabbit skin.
Executive summary:

In a primary dermal irritation study according to 40 CFR, Subdivision F, par. 158.50 and 158.135; Section 81-5, 6 New Zealand White rabbits were dermally exposed to 0.5 mL of Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid (22.5% a.i.) for 4 hours under semi-occlusive conditions.  Animals then were observed for 3 days.  Irritation was scored by the method of Draize.

Severe erythema (grade 4) and moderate to severe edema (grade 3-4) were observed after 24 h – 72 h. Reversibility cannot be fully judged as erythema scores of 4 and edema scores of 3 – 4 were still present at the end of the observation period of 3 days. As all animals displayed severe blistering and eschar formation, no full reversibility after 21 days is assumed. Thus, the substance is considered to be corrosive.