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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1',1'',1'''-ethylenedinitrilotetrapropan-2-ol
EC Number:
203-041-4
EC Name:
1,1',1'',1'''-ethylenedinitrilotetrapropan-2-ol
Cas Number:
102-60-3
Molecular formula:
C14H32N2O4
IUPAC Name:
1-({2-[bis(2-hydroxypropyl)amino]ethyl}(2-hydroxypropyl)amino)propan-2-ol
Details on test material:
- Name of test material (as cited in study report): Lutropur Q
- Physical state: viscous fluid
- Analytical purity: technical
- Impurities: none
- Lot/batch No.: P. 282

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: male 2.01 kg; females 2.07 kg mean
- Housing: single
- Diet: 130 g/animal/day
- Water: 250 ml tap water/animal/day
- Acclimation period: at least 8 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light):12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped at least 15 h before application
Vehicle:
unchanged (no vehicle)
Controls:
other: negative control: untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 (1 male , 2 females)
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm on the upper third of the back or flanks
- Type of wrap if used: Test patches were secured in position with a porous dressing (four layers of absorbent gauze and porous bandage)


REMOVAL OF TEST SUBSTANCE
- Washing: at the end of the exposure period with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 hours


SCORING SYSTEM: OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Irritant / corrosive response data:
Non-irritant

Applicant's summary and conclusion