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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other: scientifically acceptable and valid study, limited documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1957
Report date:
1957

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: BASF-Test ("Zeittest" 1, 5 , 15 min and 20 h test item exposure on skin and ear)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-diethylaminophenol
EC Number:
202-090-9
EC Name:
3-diethylaminophenol
Cas Number:
91-68-9
Molecular formula:
C10H15NO
IUPAC Name:
3-(diethylamino)phenol
Details on test material:
- Name of test material (as cited in study report): Diäthyl-m-aminophenol
- Physical state: solid
- Analytical purity: 99 %
- Other: soluble in acetic acid, alcohol, lutrol, ethylenechloride, unsoluble in soda solution and vegetable oil

Test animals

Species:
rabbit
Strain:
Vienna White

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: water or alcohol
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: the application site was covered with powdered and moistened test substance
- Concentration: 50 % in water (pulp) or 50 % in alcohol (almost dissolved)

Duration of treatment / exposure:
- 1, 5, 15 min and 20 h
Observation period:
7- 14 days
Number of animals:
- 2 animals per time point
Details on study design:
Before OECD Guideline 404 was established in 1982, skin irritation was tested using an internal method (BASF test).

White Vienna rabbits were used. Usually, 2 animals were treated for 1, 5 and 15 minutes and 2 other animals for 20 hours using occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the powdered and moistened test substance. In addition, skin tissue from the ear was tested by wrapping the ear.

After the application time of 1, 5 or 15 min, the skin was washed with Lutrol conc and Lutrol 50 % in water.
The skin exposed 20 h to the test substance remained unwashed after application.


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
Exposure time 20 hours
Basis:
animal #1
Remarks:
50% in water
Time point:
other: within 14 days
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48h
Remarks:
slight dequamation on d4
Irritation parameter:
edema score
Remarks:
Exposure time 20 hours
Basis:
animal #1
Remarks:
50% in water
Time point:
other: within 14 days
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Remarks:
Exposure time 20 hours
Basis:
animal #2
Remarks:
50% in water
Time point:
other: within 14 days
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks:
discoloration
Irritation parameter:
edema score
Remarks:
Exposure time 20 hours
Basis:
animal #2
Remarks:
50% in water
Time point:
other: within 14 days
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Remarks:
Exposure time 20 hours
Basis:
animal #1
Remarks:
50% in alcohol
Time point:
other: within 14 days
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks:
discoloration
Irritation parameter:
edema score
Remarks:
Exposure time 20 hours
Basis:
animal #1
Remarks:
50% in alcohol
Time point:
other: within 14 days
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Remarks:
Exposure time 20 hours
Basis:
animal #2
Remarks:
50% in alcohol
Time point:
other: within 14 days
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 9d
Remarks:
slight desquamation on d9
Irritation parameter:
edema score
Remarks:
Exposure time 20 hours
Basis:
animal #2
Remarks:
50% in alcohol
Time point:
other: within 14 days
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 9d

Any other information on results incl. tables

The following table shows an overview of the obtained results in the irritation tests.

Erythema and edema were scored immediately after exposure period.

Concentration Animal Skin
    1 min 5 min 15 min 20 h
50 % in water 1 Erythema: 1           fully reversible within 24h Erythema: 1        fully reversible within 24h ;    slight desquamation on d4 Erythema: 1    fully reversible within 24h;       slight desquamation on d4 Erythema: 1     fully reversible within 48h;     slight desquamation on d4
  2 No skin findings No skin findings No skin findings discoloration          No further skin findings
50 % in alcohol 1 Erythema: 2  slight desquamation on d5 Erythema: 2   slight desquamation on d5 Erythema: 2   fully reversible within 5d       discoloration          No further skin findings
  2 Erythema: 1  fully reversible within 5d       Erythema: 1 fully reversible within 5d       Erythema: 2   small patchy necrotic areano skin findings on d14 Erythema: 3  Edema:3                fully reversible within 9d;       slight desquamation on d9

Ø no symptom

1 indicated erythema

2 slight erythema

3 well defined erythema

3 well defined edema

4 severe erythema

Findings in ear:

Application for 20 hours in water resulted in no findings.

Application for 20 hours in alcohol resulted in discoloration and erythema (2), beeing reversible within 4 days.

Applicant's summary and conclusion