3-aminopropan-1-ol

Endpoint summary

Description of key information

Not sensitzing to guinea pigs after repeated epicutaneuos exposure (BASF 1962)

The substance is also classified as corrosive to the skin cat. 1B

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as skin corrosion (Category 1, 1A, 1B or 1C)

Reference 2

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

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.

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

no data

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

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Skin sensitization

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 (BASF, 1962).

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

No sensitizing effect was observed in guinea pigs. Classification according to Regulation (EC) No. 1272/2008 (CLP) is not required.