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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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: Acceptable, well documented report which meets basic scientific principles. Acceptable with restrictions (limited documentation, only 2 animals, occlusive conditions, 72-hrs reading missing, observation period only 8 days).

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970
Reference Type:
other company data
Title:
Unnamed
Year:
2002
Report date:
2002

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 8 days and skin reactions were recorded 24, 48 hours, 5 and 8 days after treatment.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-ethylpiperidine
EC Number:
212-161-6
EC Name:
1-ethylpiperidine
Cas Number:
766-09-6
Molecular formula:
C7H15N
IUPAC Name:
1-ethylpiperidine
Details on test material:
- Name of test material (as cited in study report): Aethylpiperidin
- Physical state: liquid
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 4.1 and 2.72 kg (females)

ENVIRONMENTAL CONDITIONS
- no data

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
1, 5, 15 min
Observation period:
8 days
Number of animals:
2
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

SCORING SYSTEM:
- Descriptive scores of the raw data have been converted to Draize numerical scores.

READINGS:
- 24 and 48 hours as well as 8 days after treatment.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Necrosis
Remarks on result:
other: ≥ 5 min exposure duration led to fullthickness necrosis observed after 24 hours.
Irritation parameter:
erythema score
Remarks:
(exposure duration: 1 min)
Basis:
mean
Remarks:
(animal #1 and #2)
Time point:
other: 24 and 48 hours
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Necrosis (parchment-like)
Irritation parameter:
edema score
Remarks:
(exposure duration: 1 min)
Basis:
mean
Remarks:
(animal #1 and #2)
Time point:
other: 24 and 48 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Remarks:
(exposure duration: 5 min)
Basis:
mean
Remarks:
(animal #1 and #2)
Time point:
other: 24 and 48 hours
Score:
2.5
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Necrosis (hard)
Irritation parameter:
edema score
Remarks:
(exposure duration: 5 min)
Basis:
mean
Remarks:
(animal #1 and #2)
Time point:
other: 24 and 48 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Remarks:
(exposure duration: 15 min)
Basis:
mean
Remarks:
(animal #1 and #2)
Time point:
other: 24 and 48 hours
Score:
2.5
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Necrosis (hard)
Irritation parameter:
edema score
Remarks:
(exposure duration: 15 min)
Basis:
mean
Remarks:
(animal #1 and #2)
Time point:
other: 24 and 48 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
1 min exposure:
on the day of application bleedings at the application side and moderate to strong redness (score 2 - 3) occured; after 24 and 48 hours: strong redness (score 3) and edema (score 2); after 5 days redness (score 3) and edema (score 3) and blotchy necrosis; at the end of the observation period parchment-like necrosis, not reversible.
5 min exposure:
on the day of application leathery necrosis was observed; after 24 and 48 hours hard necrosis with reddened edge (erythema score 2 to 3), after 5 days and at the end of the observation period hard, leathery necrosis, not reversible.
15 min exposure:
on the day of application leathery necrosis was observed; after 24 and 48 hours hard necrosis with reddened edge (erythema score 2 to 3), after 5 days and at the end of the observation period hard, leathery necrosis, not reversible.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive)
Remarks:
Migrated information