Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

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: Non-GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material: Nicotinic acid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: Individual body weights were within the range 2.2 - 3.0 kg.
- Housing: The animals were caged individually in grid floor cages.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: The animals were acclimatised to the laboratory environment for a minimum of 7 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not controlled, but min. 14 °C
- Humidity (%): Not controlled
- Air changes: Fan controlled air circulation
- Photoperiod: natural lighting conditions supplemented with fluorescent lighting during the working hours (8.45 to 17.00)

IN-LIFE DATES: From: 09.1979 To: 09.1979

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g.
- The test article was moistened with water for administration.
Duration of treatment / exposure:
Portions of the test article (0.5 g) were applied to one intact and one abraded site on each animal and covered with patches of gauze. Four hours after treatment the wrappings and collars were removed.
Observation period:
Immediately after removal of the wrappings the skin reactions on both the intact and abraded sites were scored. Following this initial reading the test sites were washed with warm water to prevent further exposure to the test article. The evaluation of the skin reactions was repeated 24, 48 and 72 hours after treatment.
Number of animals:
Six New Zealand White rabbits were used for the study.
Details on study design:
TEST SITE
- Area of exposure: 25 mm x 25 mm
- % coverage: 100
- Type of wrap if used: A small plug of cotton wool weighing approximately one g was placed over the top of the pads to achieve uniform pressure over the whole treated surface. The pads were held in place by a strip of adhesive impermeable plaster. An Elizabethan collar was placed around the neck of each animal to prevent removal of the wrapping.

REMOVAL OF TEST SUBSTANCE
- Washing: Yes, washed with warm water
- Time after start of exposure: 4 h

SCORING SYSTEM: U. S. Food and Drug Administration "Appraisal of the Safety Chemicals in Foods, Drugs and Cosmetics," 1959

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 4, 24, 48, 72
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4, 24, 48, 72
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4, 24, 48, 72
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4, 24, 48, 72
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
A primary irritation index of 0.0 was obtained. The test article is therefore regarded as a non irritant. No skin reactions were noted in any of the animals during the observation period.
The test article did not produce a corrosive response as defined by the Code of Federal Regulations, Title 49, Part 173, 1976. No evidence of tissue destruction was noted during the observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A primary skin irritation and corrosivity study was performed in the albino rabbit on the test item. No skin irritation was noted in any of the six animals at any of the observations at 4, 24, 48 and 72 h. A primary irritation index of 0.0 was obtained. The test article was therefore regarded as a non-irritant. The test item did not produce a corrosive response as defined by the Code of Federal Regulations Title 49, Part 173, 1276.
Executive summary:

A study similar or equivalent to EU Method B.4 and OECD Guideline 404 (Acute Dermal Irritation / Corrosion) was carried out. A group of six albino rabbits was treated with the test item (occlusive with 4 h exposure). No skin irritation was noted in any of the six animals at any of the observations at 4, 24, 48 and 72 h. A primary irritation index of 0.0 was obtained following observations at 4, 24, 48 and 72 h. The test article was therefore regarded as a non-irritant. The test item did not produce a corrosive response as defined by the Code of Federal Regulations Title 49, Part 173, 1276.