Registration Dossier

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:
other: Acceptable, well documented report which meets basic scientific principles. Acceptable with restrictions (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:
BASF-test.
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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tri-2-Aethylhexylamine
- Physical state: liquid
- Analytical purity: approx. 98%

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals 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:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin site of the same animal served as control
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

Mean erythema score after 24 and 48 h (72 h reading is missing); (animal 1/2):

 Exposure time  24 h  48 h  72 h  mean        
  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        

Mean edema score after 24 and 48h (72 h reading is missing); (animal1/2):

 Exposure time  24 h  48 h  72 h  mean        
 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        

-/-: 72 h reading is missing.

In a study with undiluted Tris(2-ethylhexyl)amine, exposure times of 1, 5, 15 min and 20 h 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.

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

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information