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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1962
Report date:
1962

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
BASF-Test following internal SOP
GLP compliance:
not specified
Type of study:
skin painting test
Justification for non-LLNA method:
Study was carried out before the LLNA method requirement existed.

Test material

Constituent 1
Chemical structure
Reference substance name:
3-aminopropan-1-ol
EC Number:
205-864-4
EC Name:
3-aminopropan-1-ol
Cas Number:
156-87-6
Molecular formula:
C3H9NO
IUPAC Name:
3-aminopropan-1-ol

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
other: undiluted or in acetone
Concentration / amount:
Initial application: undiluted; following daily applications: 50 % dilution in acetone
Day(s)/duration:
5 times per week, 2 weeks
Challenge
Route:
epicutaneous, open
Vehicle:
other: undiluted or in acetone
Concentration / amount:
5 % dilution in acetone
No. of animals per dose:
12 animals were used
Details on study design:
10 guinea pigs were shaved on the right and left flank. The area was about 25cm². After 4 hours, the left flank was defatted with ether. The undiluted test substance was then painted three times to the shaved skin. The subsequent daily (5 times per week) applications (10 paintings) were carried out with a 50 % solution of the test substance in acetone. During the course of this treatment, all 10 animals developed bloody crusts on the site of the application. The animals were then left untreated for 12 days and the skin changes on the left flank were able to heal. The 10 guinea pigs were then shaved again on the right and left flank. After 4 hours, the right so far untreated flank was defatted with ether and then treated with a 5 % solution of the test substance in acetone. The area was judged 12 hours after the treatment and no skin reaction was observed. 2 previously untreated animals served as controls and showed that the treatment with the 5 % solution of the test substance in acetone was not irritating to the skin.
Challenge controls:
2 previously untreated animals were used as challenge controls
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
12
Group:
test chemical
Dose level:
5 % test substance in acetone
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no skin reactions
Key result
Reading:
1st reading
Hours after challenge:
12
Group:
negative control
Dose level:
5 % test substance in acetone
No. with + reactions:
0
Total no. in group:
2
Clinical observations:
no skin reactions
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested

Any other information on results incl. tables

The repeated application of a 50 % dilution to the flank skin of 10 guinea pigs led to severe irritation of the skin resulting in necrosis formation after several days.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The repeated application of a 50 % dilution to the flank skin of 10 guinea pigs led to severe irritation of the skin resulting in necrosis formation after several days. The animals were then left untreated for 12 days and the skin changes on the left flank were able to heal. The 10 guinea pigs were then shaved again on the right and left flank. After 4 hours, the right so far untreated flank was defatted with ether and then treated with a 5 % solution of the test substance in acetone. The area was judged 12 hours after the treatment and no skin reaction was observed. 2 previously untreated animals served as controls and showed that the treatment with the 5 % solution of the test substance in acetone was not irritating to the skin.
Executive summary:

10 guinea pigs were shaved on the right and left flank. The area was about 25cm². After 4 hours, the left flank was defatted with ether. The undiluted test substance was then painted three times to the shaved skin. The subsequent daily (5 times per week) applications (10 paintings) were carried out with a 50 % solution of the test substance in acetone. During the course of this treatment, all 10 animals developed bloody crusts on the site of the application. The animals were then left untreated for 12 days and the skin changes on the left flank were able to heal. The 10 guinea pigs were then shaved again on the right and left flank. After 4 hours, the right so far untreated flank was defatted with ether and then treated with a 5 % solution of the test substance in acetone. The area was judged 12 hours after the treatment and no skin reaction was observed. 2 previously untreated animals served as controls and showed that the treatment with the 5 % solution of the test substance in acetone was not irritating to the skin.