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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
From 14 MAR 1984 to 06 MAY 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets sceintific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Principles of method if other than guideline:
skin sensitisation test in guinea pigs. Primary irritation phase (1 drop open epikutan). Two days thereafter followed by induction phase (4 intradermal injections with 0.1 ml of 1% (v/v) emulsion, 1 injection per week). Challenge treatment (open epicutan) of animals was done two weeks after last induction injection.
GLP compliance:
no
Type of study:
intracutaneous test

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylpentane-1,5-diamine
EC Number:
239-556-6
EC Name:
2-methylpentane-1,5-diamine
Cas Number:
15520-10-2
Molecular formula:
C6H16N2
IUPAC Name:
2-methylpentane-1,5-diamine
Details on test material:
- Name of test material (as cited in study report): 2-methylpentanediamine, MPMD
- Substance type: clear, colourless liquid
- Physical state: fluid
- Analytical purity: 90%
- Impurities (identity and concentrations): approx. 10 % 2-ethylbutanediamine
- Composition of test material, percentage of components:
- Isomers composition:
- Storage condition of test material: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
primary irritation: 1 drop of 1 or 10 % emulsion of test substance in physiological saline
sensitisation: 4 intradermal injections of 0.1 mL of a 1.0 % emulsion
challenge: 1 drop of 1 or 10 % emulsion of test substance in physiological saline (control group also treated)
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
physiological saline
Concentration / amount:
primary irritation: 1 drop of 1 or 10 % emulsion of test substance in physiological saline
sensitisation: 4 intradermal injections of 0.1 mL of a 1.0 % emulsion
challenge: 1 drop of 1 or 10 % emulsion of test substance in physiological saline (control group also treated)
No. of animals per dose:
10 male animals per group.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no erythema or edema observed
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no erythema or edema observed.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no erythema or edema observed
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no erythema or edema observed.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
8
Total no. in group:
10
Clinical observations:
very slight erythema observed in 8/10 animals, no edema observed
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: very slight erythema observed in 8/10 animals, no edema observed.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
8
Total no. in group:
10
Clinical observations:
very slight erythema observed in 8/10 animals, no edema observed
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: very slight erythema observed in 8/10 animals, no edema observed.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no erythema or edema observed
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no erythema or edema observed.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no erythema or edema observed
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no erythema or edema observed.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
very slight erythema observed in 10/10 animals, no edema observed
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: very slight erythema observed in 10/10 animals, no edema observed.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
8
Total no. in group:
10
Clinical observations:
very slight erythema observed in 8/10 animals, no edema observed
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: very slight erythema observed in 8/10 animals, no edema observed.

Any other information on results incl. tables

All animals survived throughout the study. Animals challenged with the test material exhibited no potential to produce dermal sensitisation in guinea pigs.

erythema scores:

0: no erythema

1: slight erythema

2: mild erythema

3: moderate erythema

4: severe erythema

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the applied test conditions, the test substance is no skin sensitisiser.
Executive summary:

In an intracutaneous guinea pig test 10 male guinea pigs were treated with two concentrations of MPMD each (10 % or 1 % of test substance). First Primary irritation was tested (1 drop open epikutan). Two days thereafter 4 intradermal injections with 0.1 ml of 1% (v/v) emulsion (1 injection per week) followed.

After challenge (done open epicutaneous; two weeks after last induction injection) with the test substance animals in the 10 % group showed very slight erythema in the 24 and 48 h reading (i.e. 8/10 and 10/10 animals). In the corresponding control group (animals were only treated once in the same manner as challenge treatment was performed) 8/10 animals showed also slight erythema in the 24 and 48 h reading, revealing the irritant potential of the substance at this concentration level. In the 1 % test group no effects were observed. According to the authors the test material is no skin sensitiser.