2-amino-2-methylpropanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

solid (neat): no moistening and no coverage, application area and time unknown, no grading of skin reactions. However since neat AMP contains some trace water, and has an alkaline pH, we can assume that the results of this study reflect the alkaline properties of the test item even if no water was added. Hence skin corrosion classification can be excluded, but it is not possible to distinguish between skin irritant and not classified with this study design.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1940

Reference 2

Reference Type:

publication

Title:

The Physiological Response of Animals to Some Simple Mononitroparaffins and to Certain Derivatives of These Compounds

Author:

Machle W, Scott EW, Treon J

Year:

1940

Bibliographic source:

Journal of Industrial Hygiene and Toxicology V22, No8 (315-332)

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

5 daily applications of test material to the shaved abdomen of rabbits.
deviation to requirements for solids: not moistened

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-amino-2-methylpropanol

EC Number:

204-709-8

EC Name:

2-amino-2-methylpropanol

Cas Number:

124-68-5

Molecular formula:

C4H11NO

IUPAC Name:

2-amino-2-methylpropan-1-ol

Details on test material:

The test material used was AMP, however the purity of it is not specifically stated, although the author does indicate that all test materials were of a high degree of purity. No scoring of erythema/odema given.

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: supplier of animals not indicated, however all animals were sourced from a single supplier- Age at study initiation: All animals indicated to be 'young and healthy' nof urther information is given- Weight at study initiation: no data is given- Housing: Animals housed individually in cages - Diet (e.g. ad libitum): standard diet provided ad libitum throughout the study- Water (e.g. ad libitum): ad libitum water- Acclimation period: no details givem

Test system

Type of coverage:

open

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

a 'measured' amount of test material was applied to the skin, however no further details are given

Duration of treatment / exposure:

daily for 5 days. No indication of removal/washing of the test item after application.

Observation period:

There is no data on the observation period. At a minimum it appears that the animals were observed for the full 5 days during treatment.

Number of animals:

number of animals used is not indicated in the report

Details on study design:

Animals were prepared by closely clipping the skin over the anterior abdominal wall. After securing the animal in the supine position, a measured amount of the test material was pipetted onto the surface of the skin. The test material was allowed to "evaporate" in still air, and the animal was released to the cage after the skin was dry. However, this remark while valid for other tested (liquid) test items, makes no sense for neat AMP which is a solid.

Results and discussion

In vivo

Results

Irritation parameter:

other: see remarks

Basis:

other: see remarks

Time point:

other: see remarks

Reversibility:

not specified

Remarks on result:

other: no significant dermatitis or superficial damage to the skin

Remarks:

"No significant dermatitis or other damage to the superficial skin."

Other effects:

No symptoms, evidence of illness or significant weight changes.

Applicant's summary and conclusion

Interpretation of results:

other: Skin corrosion classification can be excluded, but it is not possible to distinguish between skin irritant and not classified with this study design.

Remarks:

non-corrosive is the only conclusion from this study

Conclusions:

When tested in rabbits, neat (solid) AMP did not produce significant skin irritation. The study has significant limitations (short summary, no moistening and no coverage, application area unknown, no grading of skin reactions). However, since neat AMP contains some trace water and has an alkaline pH, we can assume that the results of this study reflect the alkaline properties of the test item even if no water was added, and can at least allow to exclude skin corrosion.
The result of "no significant" skin irritation, taken together with the study limitations, does not allow to discriminate between irritating and non-irritating.