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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
limited documentation, only 2 animals used, 72-hrs reading missing, observation period only 8 days

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975
Reference Type:
other company data
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Principles of method if other than guideline:
Two animals were treated for 1, 5, 15 min or 20 h using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the liquid test substance. The animals were observed for 8 days and skin changes were recorded daily. For a final evaluation, the findings from 24 and 48 hours from the raw data were taken into account.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethyl-N,N-bis(2-ethylhexyl)hexylamine
EC Number:
217-461-0
EC Name:
2-ethyl-N,N-bis(2-ethylhexyl)hexylamine
Cas Number:
1860-26-0
Molecular formula:
C24H51N
IUPAC Name:
tris(2-ethylhexyl)amine
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Tri-2-Aethylhexylamin
- Physical state: liquid
- Analytical purity: approx. 98%

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.11 and 3.57 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.5 mL

Duration of treatment / exposure:
1min, 5 min, 15 min and 20 h, respectively
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5*2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): conc. Lutrol and 50 % Lutrol solution
- Time after start of exposure: 1, 5 or 15 min post exposure

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
1 min exposure
Basis:
animal #1
Time point:
24/48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: Erythema extending beyond the area of application; scaling at study termination.
Irritation parameter:
erythema score
Remarks:
1 min exposure
Basis:
animal #2
Time point:
24/48 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Erythema extending beyond the area of application; scaling at study termination.
Irritation parameter:
erythema score
Remarks:
5 min exposure
Basis:
animal #1
Time point:
24/48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: Erythema extending beyond the area of application; scaling at study termination.
Irritation parameter:
erythema score
Remarks:
5 min exposure
Basis:
animal #2
Time point:
24/48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Erythema extending beyond the area of application; scaling at study termination.
Irritation parameter:
erythema score
Remarks:
15 min exposure
Basis:
animal #1
Time point:
24/48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: Erythema extending beyond the area of application; scaling at study termination.
Irritation parameter:
erythema score
Remarks:
15 min exposure
Basis:
animal #2
Time point:
24/48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Erythema extending beyond the area of application; scaling at study termination.
Irritation parameter:
edema score
Remarks:
1, 5 and 15 min exposure
Basis:
mean
Remarks:
animal 1-2
Time point:
24/48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
animal #1
Time point:
24/48 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: Erythema extending beyond the area of application; scaling extending beyond the area of application at study termination.
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
animal #2
Time point:
24/48 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: Erythema extending beyond the area of application; scaling extending beyond the area of application at study termination.
Irritation parameter:
edema score
Remarks:
20 h exposure
Basis:
animal #1
Time point:
24/48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
edema score
Remarks:
20 h exposure
Basis:
animal #2
Time point:
24/48 h
Score:
0
Max. score:
4

Any other information on results incl. tables

Table 1: Mean erythema score after 24 and 48 h (72 h reading is missing)

Exposure time 24 h 48 h 72 h mean
animal 1 animal 2 animal 1 animal 2 animal 1 animal 2 animal 1 animal 2
1 min 2 1 2 2 - - 2 1.5
5 min 2 1 2 1 - - 2 1
15 min 2 1 2 1 - - 2 1
20 h 2 2 3 3 - - 2.5 2.5

Table 2: Mean edema score after 24 and 48h (72 h reading is missing)

Exposure time 24 h 48 h 72 h mean
animal 1 animal 2 animal 1 animal 2 animal 1 animal 2 animal 1 animal 2
1 min 0 0 0 0 - - 0 0
5 min 0 0 0 0 - - 0 0
15 min 0 0 0 0 - - 0 0
20 h 0 0 2 0 - - 1 0

The original BASF grading was converted into the numerical grading according the OECD Draize system.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
After exposure times of 1, 5, 15 min and 20 h the test material caused slight to moderate reddening of the dorsal rabbit skin extending beyond the area of exposure. After 20 h of exposure 1 animal showed slight edema after 48 h. At the end of the observation period of 8 days the animals showed at all exposure times scale formation which was extending beyond the area of exposure in the 20 h application. According to the criteria laid down in the Regulation (EC) No. 1272/2008, the substance does not need to be classified and labeled as skin irritating.