α,α-diphenylpiperidine-4-methanol hydrochloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Referenced sources in an international report.

Data source

Reference

Reference Type:

review article or handbook

Title:

Hydrogen Chloride, SIDS Initial Assessment Report For SIAM 15

Author:

OECD

Year:

2002

Bibliographic source:

UNEP PUBLICATIONS

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(1981)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Hydrogen chloride

EC Number:

231-595-7

EC Name:

Hydrogen chloride

Cas Number:

7647-01-0

IUPAC Name:

chloride

Constituent 2

Reference substance name:

Hydrochloric acid

IUPAC Name:

Hydrochloric acid

Test material form:

not specified

Details on test material:

37% of hydrochloric acid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Test animals: Animals with healthy and intact skin were used.
- Test conditions: the dorsal and lateral parts of the trunk were shorn 15-24h before treatment. The results were assessed 1, 24, 48 and 72 hr and 7 days after removal of the patch.

Test system

Type of coverage:

other: occlusive and semi-occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

Amount: 0.5 mL of 37% HCl
Concentration: 12 mol/L

Duration of treatment / exposure:

Both 1 and 4 hours exposure

Observation period:

1, 24, 48 and 72 hr and 7 days after removal of the patch

Number of animals:

6 animals per sex per dose

Details on study design:

Four samples were attached dorsally (laterally) to each animal. The local reactions were determined after both 1 and 4 hr exposure both under occlusive and semi-occlusive conditions. 0.5 mL/patch were applied to gauze pads 3 cm x 3 cm. The patches were fixed on the prepared skin areas of the flanks and covered by wrapping an airpermeable circular bandage (semi-occlusive method) or airtight plastic foil (occlusive method) around the animals. After removal of the bandages and patches the treated skin areas were rinsed with water and dried.

Results and discussion

In vivo

Irritant / corrosive response data:

The test substance was corrosive after both 1 hr and 4 hr application of occlusive or semi-occlusive exposure. However, the cumulative total and percent responders were not described.

Any other information on results incl. tables

Reference: Potokar, M. (1985) Studies on the Design of Animal Tests for the Corrosiveness of Industrial Chemicals. Fd. Chem. Toxic., 23, 615-617.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: other: Classified as the material which causes buns according to EEC (1967)

Conclusions:

Hydrochloric acid at 37% is corrosive to skin. Azacyclonol base is considered to be non irritant to the skin. HCl is present in the mixture Azacyclonol HCl in a content of 11%. Azacyclonol HCl is expected to be at least slightly irritant for the skin.