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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2006-08-02 to 2006-09-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
not specified
Remarks:
The study is performed before 2008, with report available in 2012.
Type of study:
Buehler test
Justification for non-LLNA method:
The Murine Local Lymph Node Assay (LLNA) is the first-choice method for in vivo testing according to the REACH Regulation. However, this reliable Buehler test was performed before entry into force of the REACH Regulation.

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[(3-aminopropyl)methylamino]ethanol
EC Number:
255-615-9
EC Name:
2-[(3-aminopropyl)methylamino]ethanol
Cas Number:
41999-70-6
Molecular formula:
C6H16N2O
IUPAC Name:
2-[(3-aminopropyl)(methyl)amino]ethan-1-ol
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: E-015/2005-1
- Purity test date: 2005-10-24
- Purity: 99.01 wt% (GC)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Solubility and stability of the test substance in the solvent/vehicle: no data



In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Remarks:
Hsd: POC DH
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan
- Age at study initiation: 4 weeks at start of dosing
- Weight at study initiation: 300-366 grams
- Housing: Animals were individually housed upon receipt and upon assignment to study in compliance with USDA Guidelines. Calvert is a USDA registered and fully AAALAC accredited facility. The room in which the animals were kept was documented in the study records. No other species were kept in the same room.
- Diet (e.g. ad libitum): All animals had access to Harlan Teklad Guinea Pig Diet (certified) ad libitum
- Water (e.g. ad libitum): Tap water was available ad /ibitum, to each animal via an automatic watering device
- Acclimation period: minimum of 7 days prior to dosing
- Indication of any skin lesions: not indicated

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19° to 26°C
- Humidity (%): 45 to 80%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
concentration:
100%
volume:
0.3 mL per site
Day(s)/duration:
weeks 1 - 3: a total of three 6-hour exposures to the test item
Adequacy of induction:
other: concentration chosen for induction was generally one that produces mild irritation
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
concentration:
80%
volume: 0.3 mL per site
Day(s)/duration:
weeks 1 - 3: a total of three 6-hour exposures to the test item
Adequacy of induction:
other: concentration chosen for induction was generally one that produces mild irritation
Challenge
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
concentration:
70%
volume:
0.3 mL per site
Day(s)/duration:
Fourteen days after the last induction
Adequacy of challenge:
other: highest concentration to be used was generally one in the vehicle used that induced no scores >= 1 and scores not exceeding two ± in the groupo of four animals
No. of animals per dose:
primary irritation test: 4; secondary screen: 4; test article: 20 (10m, 10f); positive control: 6 (3m, 3f); vehicle control: 10 (5m, 5f)
Details on study design:
RANGE FINDING TESTS:
Dose-Range-Finding Study
a) Primary Irritation Screens: Prior to initiation of the main study, the irritation potential was determined. Four naive animals were exposed to four different concentrations of the test material by the patching technique described in site preparation and treatment. The location of each of the four concentrations of test article differed in each of the four animals to compensate for any site-to-site variations. For grading of the response, the procedure described below for primary challenge was used, except that only 24-hour grades were obtained. The concentration chosen for induction was generally one that produces mild irritation. The highest concentration to be used for challenge was generally one in the vehicle used that induces no scores > = 1and scores not exceeding two ± in the group of four animals.
b) Secondary Irritation Screen: An additional irritation screen was performed using four additional animals. Doses of 60%, 70%, 80% and 90% were investigated to choose the second and third induction doses and the challenge dose.
The dose chosen for induction: 0.3 ml
The dose chosen for challenge: 0.3 ml

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Test groups: 80% and 100% of test material in physiological saline
- Control group: vehicle only
- Frequency of applications: once a week
- Duration: 6 h
- Concentrations: 80% and 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 6 hours
- Test groups: 70% of test material
- Control group: vehicle only
- Concentrations: 70%

Positive control substance(s):
yes
Remarks:
1-chloro-2, 4-dinitrobenzene (DNCB) (induction: 0.3% in 80% ethanol; challenge: 0.2% in acetone)

Results and discussion

Positive control results:
The positive control group, induced and challenged with DNCB, exhibited the anticipated positive responses at challenge, indicating that the methods employed in this study were valid.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
70%
No. with + reactions:
4
Total no. in group:
20
Clinical observations:
no signs of systemic toxicity and all animals gained weight during the study
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
70%
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
no signs of systemic toxicity and all animals gained weight during the study
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.2%
No. with + reactions:
6
Total no. in group:
6
Clinical observations:
no signs of systemic toxicity and all animals gained weight during the study
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.2%
No. with + reactions:
6
Total no. in group:
6
Clinical observations:
no signs of systemic toxicity and all animals gained weight during the study
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no signs of systemic toxicity and all animals gained weight during the study
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no signs of systemic toxicity and all animals gained weight during the study
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
70% test item
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
no signs of systemic toxicity and all animals gained weight during the study
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
70% test item
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
no signs of systemic toxicity and all animals gained weight during the study

Applicant's summary and conclusion

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
Under the conditions of this study, induction with the test substance at 100 and 80% did elicit a delayed contact hypersensitivity response in guinea pigs when challenged with the test article at 70%.