Pyrrolidine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study meets generally accepted scientific standards, acceptable for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1959

Report date:

1959

Materials and methods

Principles of method if other than guideline:

Standardized test method (BASF-Test)
Before OECD Guideline 404 was established in 1982, skin irritation was tested using an internal method (BASF test). White Vienna rabbits were used. 2 animals were treated for 1, 5, 15 minutes using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the liquid test substance on a patch. After the application time of 1, 5, and 15 minutes, respectively, the skin was first washed with undiluted Lutrol 9, then with an aqueous Lutrol solution (50 %). The animals were observed for 7 weeks and skin reactions were recorded daily in the beginning and every 4 to 7 days after 10 days.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Pyrrolidine

EC Number:

204-648-7

EC Name:

Pyrrolidine

Cas Number:

123-75-1

Molecular formula:

C4H9N

IUPAC Name:

pyrrolidine

Details on test material:

- Name of test material (as cited in study report): Pyrrolidin
- Physical state: liquid
- Analytical purity: 95 - 97 %

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3.25 and 3.14 kg

ENVIRONMENTAL CONDITIONS
no data

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): undiluted, no amount specified

Duration of treatment / exposure:

1 min, 5 min, 15 min

Observation period:

7 weeks

Number of animals:

2 animals

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: no data

REMOVAL OF TEST SUBSTANCE
- Washing: yes (exposure 1, 5, 15 min) first with undiluted Lutrol 9, then with an aqueous Lutrol solution (50 %)
- Time after start of exposure: 1, 5, and 15 min, respectively

Results and discussion

In vivo

Results

Irritation parameter:

erythema score

Remarks on result:

other: 1 min exposure duration led to full-thickness necrosis observed after 24 hours.

Irritant / corrosive response data:

1 min exposure:
after removal of the test substance: blood loss at the whole application side;
after 24 hours: hard, deep and black necrosis with reddened oedematous edge;
after 8 days: not relocatable, deep necrosis;
after 7 weeks: relocatable scar.
5 min exposure:
Except for a non-relocatable scar, grown together with the muscle, the same findings as after 1 min exposure were observed.
15 min exposure:
Same findings as observed after 5 min exposure.

Applicant's summary and conclusion

Interpretation of results:

Category 1A (corrosive)

Remarks:

Migrated information

Conclusions:

The test item is considered to be corrosive to the skin.

Executive summary:

In this non-GLP test (BASF IX/409, 1959) skin irritation was tested according to an internal method (BASF test). White Vienna rabbits were used. 2 animals were treated for 1, 5, 15 minutes using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the liquid test substance on a patch. After the application time of 1, 5, and 15 minutes, respectively, the skin was first washed with undiluted Lutrol 9, then with an aqueous Lutrol solution (50 %). The animals were observed for 7 weeks and skin reactions were recorded daily in the beginning and every 4 to 7 days after 10 days.

Already the one-minute exposure duration led to full-thickness necrosis on the skin observed after 24 hours. The test item is considered to be corrosive to the skin and is classified cat. 1.