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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Mouse Ear Swelling Test of Diethylamine
Author:
Virginia Chemicals
Year:
1987
Bibliographic source:
EPA Doc. No. 86-870000814; Fiche No. OTS0515252

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: Gad, S.C., Toxicol. Appl. Pharmacol., 1984, 93 - 114
Deviations:
not specified
GLP compliance:
not specified
Type of study:
mouse ear swelling test

Test material

Constituent 1
Chemical structure
Reference substance name:
Diethylamine
EC Number:
203-716-3
EC Name:
Diethylamine
Cas Number:
109-89-7
Molecular formula:
C4H11N
IUPAC Name:
diethylamine

In vivo test system

Test animals

Species:
mouse
Strain:
CF-1
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: topical, no data on occlusion
Vehicle:
no data
Concentration / amount:
- induction: 1.0% (v/v)
- challenge, recallenge: 50% (v/v)
Challengeopen allclose all
Route:
other: topical, no data on occlusion
Vehicle:
no data
Concentration / amount:
- induction: 1.0% (v/v)
- challenge, recallenge: 50% (v/v)
No. of animals per dose:
10
Details on study design:
The dermal sensitization potential of diethylamine (CAS # 109-89-7) was evaluated in 10 CF1(BR) mice inducted with 3 daily 0.1 mL topical applications of a 1.0% (v/v) test solution to clipped abdomens. Challenge and rechallenge were administered 7 and 14 days later in dermal applications of a 50% solution to both dorsal and ventral surfaces of the left and right ears, respectively, of inducted test mice. Ear thickness measured at 24 and 48-hour evaluations indicated the degree of sensitization.
Challenge controls:
A group of 10 mice likewise inducted over 3 days with 0.1 mL dermal applications of 0.5% DNCB served as the positive control.
Positive control substance(s):
yes
Remarks:
DNCB, 0.5% (v/v)

Results and discussion

Positive control results:
80% and 100% positive response in the DCNB-inducted and challenged groups at 24-hour and 48-hour evaluations, respectively, confirmed the validity of the test system.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50% (v/v)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% (v/v). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% (v/v)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% (v/v). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
50% (v/v)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 50% (v/v). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
50% (v/v)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 50% (v/v). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
no data
No. with + reactions:
8
Total no. in group:
10
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: no data. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
no data
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: positive control. Dose level: no data. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: no data.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information