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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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)
Remarks:
MEST
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1 Dec - 28 Dec 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

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

Materials and methods

Principles of method if other than guideline:
Method: according to Gad, S.C. et al.: Toxicol. Appl. Pharmacol. 84, 93-114
GLP compliance:
not specified
Remarks:
Qualite Assurance Statement available
Type of study:
mouse ear swelling test
Justification for non-LLNA method:
The LLNA method was not available yet by the time the study was conducted.

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
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- lot/batch No.of test material: C-1039

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature

In vivo test system

Test animals

Species:
mouse
Strain:
CF-1
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: River Breeding Laboratories, Inc. Kingston, New York
- Age at study initiation: Approximately 6-8 weeks
- Weight at study initiation: 20-26 grams
- Housing: housed 2-5/cage
- Diet: Purina Laboratory Chow, #5001, ad libitum
- Water (e.g. ad libitum): Municipal water supply, ad libitum
- Acclimation period: 13 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
other: 70% ethanol
Concentration / amount:
1%
Adequacy of induction:
other: maximum non-corrosive concentration
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, open
Vehicle:
other: 70% ethanol
Concentration / amount:
50%
Adequacy of challenge:
highest non-irritant concentration
No.:
#2
Route:
epicutaneous, open
Vehicle:
other: 70% ethanol
Concentration / amount:
50%
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Range finding: 10
Sensitization Study: 20 test animals (10 per group)
Irritation Control: 15 (5 per group)
Positive control substance(s):
yes
Remarks:
DNCB (2,4-dinitrochlorobenzene)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
1%
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
1%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

Challenge and rechallenge elicited no response in either test or irritation control groups at 24 or 48-hour evaluations. Conversely, 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

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the study, the test material exhibited no potential to produce sensitization in mice.
Executive summary:

The test substance was evaluated for dermal sensitization in 20 female CF-1 mice by mouse ear swelling test according to Gad, S.C. et al.: Toxicol. Appl. Pharmacol. 84, 93-114. Following induction, the challenge was administered by topical application of 50% solution on day 10. A rechallenge was performed 7 days later with a topical application of 50% solution. Challenge and rechallenge elicited no response in either test or irritation control groups at 24 or 48-hour evaluations. In contrast, 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.