Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
In vivo study performed for this endpoint prior to perfection of in vitro assays. Data obained from this study is considered accurate for determination of lack of corrosivity.
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Not applicable
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Methodology used was similar to guideline, no indication of GLP but reporting sufficient to assess the endpoint

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Deviations:
yes
Remarks:
The rabbit skin was evaluated only after four hours of exposure.
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Remarks:
Conducted prior to GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
AMP-Regular - Containing approximately 98-99% AMP
Lot. C250222 and Lot. 4K01-9B
and

AMP-95- Containing approximately 95% AMP and approx. 5% water
Lot. #1 and Lot. 4F13-9C
No further characterisation information given

Test animals

Species:
rabbit
Strain:
other: Albino (no other data given)

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml of test material as received
Duration of treatment / exposure:
4 hours
Observation period:
immediately after removal of occlusive dressing
Number of animals:
6

Results and discussion

In vivo

Results
Irritation parameter:
other: Corrosion
Basis:
mean
Time point:
other: 4 hours
Remarks on result:
other: Not Corrosive

Any other information on results incl. tables

Only the corrosivity was determined, as such no information is provided on individual animal scores for erythema and edema. The conclusion of the assay was that the materials tested were not corrosive. No information is given on the irritancy of the material under the test circumstances.

Applicant's summary and conclusion

Interpretation of results:
other: not corrosive
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
AMP-95 and AMP regular are consided non-corrosive.
Executive summary:

The skin corrosion potential of 2-amino-2-methyl-1-propanol (AMP) was studied extensively in 1975 when the US

Department of Transportation "harmonized" its classification criteria with those recommended by the UN experts.

At that time GLP requirements had not been established so the procedure in the Pharmacology Laboratory of

Commercial Solvents Corporation was to provide results on one-page Bioassay forms.

Because these tests at 4 hours exposure demonstrate that AMP is not corrosive, it is not necessary to redo the studies

with the modern protocol that protocol is designed to refine the hazard of corrosive materials for the assignment of

packing groups.