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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Study period:
21 January 1991 - 7 March 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
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 test was performed before entry into force of the REACH Regulation.

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methoxypropylamine
EC Number:
226-241-3
EC Name:
3-methoxypropylamine
Cas Number:
5332-73-0
Molecular formula:
C4H11NO
IUPAC Name:
3-methoxypropan-1-amine
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 6398-24-1, Project #90-018
- Substance type: clear colorless liquid
- Physical state: liquid
- Analytical purity: responsibility of the sponsor
- Stability under test conditions: no apparent change in the physical appearance of the test article during administration
- Storage condition of test material: responsibility of the sponsor

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Buckberg Lab Animals, Tomkins Cove, New York
- Weight at study initiation: 300-700 g
- Age at study initiation: no data
- Housing: individually in wire mesh cages
- Diet (e.g. ad libitum): purina guinea pig diet, ad libitum
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period: minimum 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
other: 80% ethanol (inductions) and acetone (challenge)
Concentration / amount:
Volume administered: 0.3 ml/dose
Induction: 5.0% (v/v); challenge: 5.0% (v/v)
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: 80% ethanol (inductions) and acetone (challenge)
Concentration / amount:
Volume administered: 0.3 ml/dose
Induction: 5.0% (v/v); challenge: 5.0% (v/v)
No. of animals per dose:
dose range: 8 (4 males, 4 females);
test article: 20 (10 males, 10 females);
positive control: 5 (2 males, 3 females);
negative control: 10 (5 males, 5 females)
Details on study design:
RANGE FINDING TESTS:
8 animals (4 males, 4 females) were each exposed to 4 concentrations of the test material in either 80% ethanol (test concentrations of 1, 10, 50 and 100%) or acetone (test concentrations of 1.0, 2.5, 5.0 and 10%)
Primary irritation responses were graded after 24h as follows:
0 = no reaction
+ = slighly patchy erythema
1 = slight of confluent or moderate patchy erythema
2 = moderate erythema
3 = severe erythema with/without edema
The highest non-irritatting concentration was that concentration in the vehicle that induced responses not exceeding two + and two 0 grades in the group of 4 animals.
Based upon the results of the dose-range-finding studies and in discussion with the sponsor, the test article was dosed at 5.0% in 80% ethanol for induction and at 5.0% in acetone for challenge.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 inductions
- Exposure period: Once a week for three weeks, a total of three six-hour inductions.
- Test groups: test substance in vehicle (80% ethanol)
- Control group: vehicle only
- Site: left shoulder
- Frequency of applications: once a week
- Duration: 6 h
- Concentrations: 5.0%


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after the last induction sensitizing exposure
- Test groups: test substance in vehicle (acetone)
- Control group: vehicle only (left flank), test article (right flank)
- Site: naive site on left side
- Concentrations: 5.0%
- Evaluation (hr after challenge): 24 and 48h


OTHER:
24h after challenge, all animals were depilated with Neet Cream Hair Remover (Whitehall Laboratories, Inc., New York). A minimum of 2h after depilation, test sites were graded.
Challenge controls:
The negative control group was challenged with vehicle (acetone) on the left flank.
Positive control substance(s):
yes
Remarks:
1-chloro-2,4-dinitrobenzene (0.3%)

Results and discussion

Positive control results:
A positive response was elicited in the animals receiving the positive control article, 1-chloro-2,4-dinitrobenezen (DNCB)

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5.0%
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
severity= 0.5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5.0%
No. with + reactions:
6
Total no. in group:
20
Clinical observations:
severity= 0.7
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.3%
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
severity= 3.0
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.3%
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
severity= 3.0
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
vehicle (acetone)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
severity= 0.0
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
vehicle (acetone)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
severity= 0.0
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
other: naive control
Dose level:
5.0% test article
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
severity= 0.1
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
other: naive control
Dose level:
5.0% test article
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
severity= 0.1

Any other information on results incl. tables

Results dose-range finding test:

Vehicle 80% ethanol: 1.0% dose caused no reaction, 10% dose caused slightly patchy erythema (1/4), slight or confluent or moderate patchy erythema (2/4) and severe erythema (1/4), 50% and 100% doses caused severe erythema.

Vehicle acetone: 1.0% and 2.5% doses caused no reaction, 5.0% dose caused no reaction (1/4) and slightly patchy erythema (3/4), 10% dose caused no reaction (2/4), slightly patchy erythema (1/4) and severe erythema (1/4).

The highest non-irritating dose (max. two animals with slightly patchy erythema) for challenge exposure was chosen to be 5% in acetone. The highest dose to cause mild irritation for induction exposure was chosen to be 5% in 80% ethanol.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
Based upon the observations made in the assay, the substance induced and challenged at a 5.0% concentration caused delayed contact hypersensitivity in guinea pigs.