Registration Dossier

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

Reference
Name:
Unnamed
Type:
Constituent
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 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