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Diss Factsheets

Administrative data

Description of key information

skin sensitisation (OECD 406, RL2) males guinea pigs, GPMT: sensitising

RA from diethylamine (CAS 109-89-7)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

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).
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.
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.
Route:
intradermal and epicutaneous
Vehicle:
maize oil
Concentration / amount:
intradermal: 0.3 - 0.01%; epicutaneous: 10.0 - 0.3%
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
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
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.
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
refer to the analogue approach justification document provided in section 13
Reason / purpose for cross-reference:
read-across source
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
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.01%+0.3% induction, 10 % challenge. No with. + reactions: 0.0. Total no. in groups: 5.0.
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
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0% induction, 10 % challenge. No with. + reactions: 0.0. Total no. in groups: 5.0.
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
CLP: Skin Sens. Cat. 1, H317
Applying the RA approach, similar results are expected for the target substance.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to diethylammonium chloride, data will be generated from information on reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.

The available data on skin sensitisation of the source substance (diethylamine) meet the criteria for classification according to

Regulation (EC) 1272/2008 as Skin Sens. Cat 1 (H317). Applying the RA-A approach, similar results are expected for the target substance diethylammonium chloride.

No data on respiratory sensitisation are available.