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Toxicological information

Skin irritation / corrosion

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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:
other: 24 h - 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:
other: 24 h - 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:
other: 24 h - 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:
other: 2 h - 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:
other: 24 h - 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:
other: 24 h - 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:
out of both animals
Time point:
other: 24 h - 48 h
Score:
0
Max. score:
4
Reversibility:
other: no symptoms
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
animal #1
Time point:
other: 24 h - 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:
other: 24 h - 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:
other: 24 h - 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:
other: 24 h - 48 h
Score:
0
Max. score:
4
Reversibility:
other: no symptons

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.