[(dimethylamino)methyl]phenol

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Study completed on 09 Nov 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

according to Corrositex test which is a standardized and reproducible method to determine potential corrosivity

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)

Version / remarks:

study performed using Corrositex assay

GLP compliance:

yes

Remarks:

Test article characterizations were not conducted but this is not expected to have an impact on outcome of the study.. Analysis of citric acid control article mixture was not performed.

Test material

Test material information

Constituent 1

Reference substance name:

[(dimethylamino)methyl]phenol

EC Number:

246-866-5

EC Name:

[(dimethylamino)methyl]phenol

Cas Number:

25338-55-0

Molecular formula:

C9H13NO

IUPAC Name:

2-[(dimethylamino)methyl]phenol

Test material form:

liquid

Details on test material:

[(dimethylamino)methyl]phenol from AP, Batch: 1610475

Specific details on test material used for the study:

Test Item Curing agent, batch 1610475, received 20 Jul 2015, characterization: clear pale-amber liquid

In vitro test system

Test system:

other: Membrane Barrier Test Kit "Corrositex™"

Vehicle:

unchanged (no vehicle)

Details on test system:

Corrositex®: An In Vitro Method for Assessing Dermal Corrosivity Potential of Chemicals, NIH Publication No. 99-4495, June 1999

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

- Test item: 500 μL of the neat test item were dispensed directly atop the bio-barrier.
- Positive Control: 1.0 N Sodium Hydroxide
- Negative Control: 1% Citric acid

Duration of treatment / exposure:

1 hour

Duration of post-treatment incubation (if applicable):

Time until observable change in CDS solution: 0 - 240 min
As result from the categorisation test, the test item were applied per bio-barrier for 1 hour

Number of replicates:

4

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: Breakthrough time in minutes

Run / experiment:

Corrositex

Value:

ca. 83.27

Vehicle controls validity:

not specified

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: Under the experimental conditions of this study, the test item is considered to be mildly corrosive (Skin Corrosion 1 C)

Any other information on results incl. tables

Test Article	Tested concentration	pH of 10% formulation	pH in Tube A	pH in Tube B	Category
Test Item	10%	9.5	na	11.5	1

	Breakthrough time in minutes					Packing group	Corrosivity
Test Article	1	2	3	4	Mean
Test Item	84.17	83.42	83.42	82.08	83.27	III	mild

Applicant's summary and conclusion

Conclusions:

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is mildly corrosive to skin and classified as skin corrosive 1 C.

Executive summary:

The test substance was tested via the Corrositex assay according to OECD 435. The test articles were analyzed using the Corrositex®test method to determine their dermal corrosivity potential and Packing Group designations. The 1.0 N Sodium Hydroxide Positive Controls had breakthrough times of 16.50, 18.00, and 19.33 minutes, which fell within the range allowed (>13.6 and <22.3 minutes). The 1% Citric Acid Negative Control had breakthrough times of >70.00 minutes, which met the acceptance criterion of >60 minutes. The results of this study indicated that the test articles, were compatible with the Corrositex®system. It can be concluded that the test item is mildly corrosive to skin and classified as skin corrosive 1 C.