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EC number: 217-461-0 | CAS number: 1860-26-0
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:
- 1 975
- Report date:
- 1975
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 002
- 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
- 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%
Constituent 1
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.
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