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Administrative data

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as skin corrosion (Category 1, 1A, 1B or 1C)
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Intercompany communication outlining the contents of a test report. The given data allows the conclusion that the study was well-performed, is sufficiently reliable and conclusions on classification can be drawn, too.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Guideline not explicitly mentioned, but given data indicates that testing was performed similar to OECD 404
Deviations:
not applicable
Principles of method if other than guideline:
New Zealand White rabbits were treated with 0.5 mL of MPA (n-Methyl-piperidyl-2-ethan-2-ol) on both an intact and abraded skin test site per rabbit. All test sites were occluded for the first 24 hours and then the wrappings were removed and the skin wiped to remove any remaining test material.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
no details available
Type of coverage:
occlusive
Preparation of test site:
other: on intact and abraded skin
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount applied : 0.5 mL
Duration of treatment / exposure:
24 h
Observation period:
14 days
Number of animals:
6 male animals
Details on study design:
Six healthy male New Zealand White rabbits were treated with 0.5 mL of MPA (n-Methyl-piperidyl-2-ethan-2-ol) on both an intact and abraded skin test site per rabbit. A respective control site per side was made. Body weights and skin examination (graded by the Draize technique) were made immediately prior to treatment and were taken at 24, 48 and 72 hours and 7 and 14 days post treatment. All test sites were occluded for the first 24 hours and then the wrappings were removed and the skin wiped to remove any remaining test material.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
6.21
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Remarks:
Due to the severe erythema and eschar observations throughout the entire duration on this study, this substance may well be classified as corrosive.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: information on score not explicitly given
Remarks:
Due to the severe erythema and eschar observations throughout the entire duration on this study, this substance may well be classified as corrosive.
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: information on score not explicitly given
Remarks:
Due to the severe erythema and eschar observations throughout the entire duration on this study, this substance may well be classified as corrosive.
Irritant / corrosive response data:
Severe erythema and eschar was observed at both the intact and abraded skin test sites on four out of six and five out of six animals respectively throughout the entire 14-day observation period post application of test material. In addition, slight to severe edema was also observed concurrently with the erythema
and eschar. A primary irritation score calculated on the basis of the 24- and 72-hour observation periods was calculated to be 6.21.
Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
The study was considered to be of sufficient reliability (reliability Klimisch 2), because, although only slightly limited information available, the available indicates that the study was properly performed. Since the primary irritation score of 6.21 is greater than 5.0, this compound would definitely be classified as a skin irritant. More importantly, due to the severe erythema and eschar observations throughout the entire duration of this study, as well as the persistence of the edema through the duration of the study, this substance may well be classified as a corrosive, which is done here. The C&L-Regulation allows also classification based on this data.
Executive summary:

The primary dermal irritation of MPA was investigated in rabbits. Six healthy male New Zealand White rabbits were treated with 0.5 ml of MPA (n-Methyl-piperidyl-2-ethan-2-ol) on both an intact and abraded skin test site per rabbit. A respective control site per side was made. Body weights and skin examination (graded by the Draize technique) were made immediately prior to treatment and were taken at 24, 48 and 72 hours and 7 and 14 days post treatment. All test sites were occluded for the first 24 hours and then the wrappings were removed and the skin wiped to remove any remaining test material.

Severe erythema and eschar was observed at both the intact and abraded skin test sites on four out of six and five out of six animals respectively throughout the entire 14-day observation period post application of test material. In addition, slight to severe edema was also observed concurrently with the erythema and eschar. A primary irritation score calculated on the basis of the 24- and 72-hour observation periods was calculated to be 6.21. Since the primary irritation score of 6.21 is greater than 5.0, this compound would definitely be classified as a skin irritant. More importantly, due to the severe erythema and eschar observations throughout the entire duration of this study, as well as the persistence of the edema through the duration of the study, this substance may well be classified as a corrosive.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion