Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 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:
2000-2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientific publication that meets basic documentation requirements. No data on positive control substance(s).

Data source

Reference
Reference Type:
publication
Title:
Comparison of dose–responses of contact allergens using the guinea pig maximization test and the local lymph node assay
Author:
Francois M.M. van Och, Rob J. Vandebriel, Menk K. Prinsen, Wim H. De Jong, Wout Slob, Henk van Loveren
Year:
2001
Bibliographic source:
Toxicology 167: 207-215

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
5 animals per group
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The in vivo test was done before LLNA as first-choice method for in-vivo testing was set into force.

Test material

Constituent 1
Reference substance name:
Diethylamine
EC Number:
203-716-3
EC Name:
Diethylamine
Cas Number:
109-89-7
Molecular formula:
C4H11N
IUPAC Name:
N-ethylethanamine
Test material form:
other: free base solution
Details on test material:
DEA (diethylamine; 99.5%; free base solution;
Sigma-Aldrich Chemie B.V., Zwijndrecht, The
Netherlands),

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Crl:(HA)BR
Sex:
male
Details on test animals and environmental conditions:
The experiments were conducted according to the maximization test method as described by Magnusson and Kligman (1969 and 1970), and according to OECD guideline no. 406 (OECD, 1992) and EC guideline B.6 (1992). Approximately 3-wk-old, male SPF-outbred albino guinea pigs (Crl:(HA)BR) with a body weight range of 175–300 g, were purchased from Charles River (Wiga, Sulzfeld, Germany). They were housed in groups of no more than 10 in a mobile battery (IFFA CREDO, Someren, The Netherlands), containing four cages with internal dimensions of 967×512×250 mm in a temperature- and humidity-controlled animal room with a 12-h light/dark cycle. Water and food (SDS Special Diets Services, Witham, UK) were provided ad libitum.
The animals were kept in quarantaine for at least 1 week before the start of the study. During this period the health status was checked by clinical observation and serological examinations.

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
maize oil
Concentration / amount:
intradermal: 0.3 - 0.01%; epicutaneous: 10.0 - 0.3%
Challenge
Route:
epicutaneous, occlusive
Vehicle:
maize oil
Concentration / amount:
30, 10, 3%
No. of animals per dose:
5 per group
Details on study design:
RANGE FINDING TESTS:
The irritation response to intradermal injection of various concentrations of the test substance (3, 1, 0.3 and 0.1%) was examined in three guinea pigs. A sufficiently large area of the flanks was clipped free from hair with electric clippers. Amounts of 0.1 mL of the selected concentrations were applied by intradermal injection. Approximately 24 h after injection, the animals were examined for signs of irritation.

MAIN STUDY
Briefly, the maximization test consists of two induction treatments, namely intradermally and topically, followed by a resting period of 14 days,which precedes the challenge treatments. Between induction treatments, a 7-day interval was employed. For the induction phase, dose response studies were performed with a fixed ratio of 33 of concentrations between the intradermal and topical administration.

A. INDUCTION EXPOSURE
- No. of exposures: intradermal + topical
- Exposure period: 24 h
- Test groups: 4
- Control group: 1
- Site:
- Frequency of applications: 2
- Duration: 24 h
- Concentrations: 0.3 + 10, 0.1 + 3, 0.03 + 1, 0.01 + 0.3

B. CHALLENGE EXPOSURE
- No. of exposures: 3 test material concentrations + 1 control
- Day(s) of challenge: 14 days after induction
- Exposure period: 24 h
- Test groups: 4
- Control group: 1
- Site:
- Concentrations: 30%, 10 %, 3%
- Evaluation (hr after challenge) 24, 48 h after removal of patches
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.3%+10% induction, 30 % challenge
No. with + reactions:
2
Total no. in group:
5
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1%+3% induction, 30 % challenge
No. with + reactions:
3
Total no. in group:
5
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.03%+1% induction, 30 % challenge
No. with + reactions:
2
Total no. in group:
5
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.01%+0.3% induction, 30 % challenge
No. with + reactions:
4
Total no. in group:
5
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0% induction, 30 % challenge
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.3%+10% induction, 30 % challenge
No. with + reactions:
3
Total no. in group:
5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.1%+1% induction, 30 % challenge
No. with + reactions:
3
Total no. in group:
5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.03%+1% induction, 30 % challenge
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.01%+0.3% induction, 30 % challenge
No. with + reactions:
1
Total no. in group:
5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0% induction, 30 % challenge
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.3%+10% induction, 10 % challenge
No. with + reactions:
1
Total no. in group:
5
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1%+3% induction, 10 % challenge
No. with + reactions:
1
Total no. in group:
5
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.03%+1% induction, 10 % challenge
No. with + reactions:
1
Total no. in group:
5
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.01%+0.3% induction, 10 % challenge
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0% induction, 10 % challenge
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.3%+10% induction, 10 % challenge
No. with + reactions:
1
Total no. in group:
5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.1%+3% induction, 10 % challenge
No. with + reactions:
1
Total no. in group:
5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.03%+1% induction, 10 % challenge
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.01%+0.3% induction, 10 % challenge
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0% induction, 10 % challenge
No. with + reactions:
0
Total no. in group:
5
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
CLP: Skin Sens. Cat. 1, H317
Diethylamine was evaluated using a dose response analysis for the GPMT with a multiple dose design. The test material was positive in this assay.