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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive conditions
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Piperidine
EC Number:
203-813-0
EC Name:
Piperidine
Cas Number:
110-89-4
Molecular formula:
C5H11N
IUPAC Name:
piperidine
Specific details on test material used for the study:
- Name of test material (as cited in study report): Piperidine
- Substance-No.: 77/283
- Physical state: liquid
- Analytical purity: 99 %
- Expiration date of the lot/batch: september 1982

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach am Main, Germany
- Weight at study initiation: 2.39 kg (male); 2.96 kg (female)
- Housing: single
- Diet: Ovator Solikanin 4 mm, Muskator-Werke, Duesseldorf, Germany; ca. 130 g per animal, daily.
- Water: Deionized water (monday to friday); Tap water (weekend); ca 250 ml per animal
- Acclimation period: ca. 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 50 - 80
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
3 min, 1 h, 4 h
Observation period:
8 days
Number of animals:
2 (one female and one male)
Details on study design:
TEST SITE
- Area of exposure: area of 2.5*2.5 cm on the upper third of the back
- Type of wrap if used: moistened cotton lint, no further data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol, Lutrol:water (1:1)
- Time after start of exposure: 3 min, 1 h and 4 h

SCORING SYSTEM: According to JH Draize: Dermal Toxicity, in: Appraisal of the saftety of chemicals in foods, drugs and cosmetics. p 46 - 59, 1959. Washington, DC: The Association of Food and Drug Officials of the United States of America, Texas, State department of Health.

READINGS
- 15 to 30 minutes after remove of the test substance, as well as after 24, 48 hours and 8 days after application. 8 day reading only with treatment duration of 4 hours.

OTHER
- In case of clinical indication of necrosis, this will be confirmed by macroscopic-pathologic evaluation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Necrosis
Remarks on result:
other: Exposure duration of 3 min led to hard leathery necrosis observed after 24 hours.
Irritation parameter:
erythema score
Remarks:
(exposure duration: 3 min)
Basis:
mean
Remarks:
(animal 1 and 2)
Time point:
24/48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Necrosis (leathery, hard), macroscopic-pathologic confirmation
Irritation parameter:
edema score
Remarks:
(exposure duration: 3 min)
Basis:
mean
Remarks:
(animal 1 and 2)
Time point:
24/48 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Remarks:
(exposure duration: 1 h)
Basis:
mean
Remarks:
(animal 1 and 2)
Time point:
24/48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Necrosis (leathery, hard), macroscopic-pathologic confirmation
Irritation parameter:
edema score
Remarks:
(exposure duration: 1 h)
Basis:
mean
Remarks:
(animal 1 and 2)
Time point:
24/48 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Remarks:
(exposure duration: 4 h)
Basis:
mean
Remarks:
(animal 1 and 2)
Time point:
24/48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 8 days
Remarks on result:
other: Necrosis (leathery, hard and extending beyond the area of application), macroscopic-pathologic confirmation
Irritation parameter:
edema score
Remarks:
(exposure duration: 4 h)
Basis:
mean
Remarks:
(animal 1 and 2)
Time point:
24/48 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
within 8 days
Irritant / corrosive response data:
The undiluted test substance was applied for 3 min, 1 and 4 h under occlusive conditions to the backs of two rabbits each.Thick and leathery necroses were observed after exposure duration of 3 min; the findings were confirmed histologically.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria