2-[(1-methylpropyl)amino]ethanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The updated versions of guidelines 404 and 405 include a Supplement that recommends the sequential testing strategy (including pH and acidic/alkaline reserve measurements) prior to undertaking the in vivo tests for corrosion/irritation of the substance.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-[(1-methylpropyl)amino]ethanol

EC Number:

252-471-9

EC Name:

2-[(1-methylpropyl)amino]ethanol

Cas Number:

35265-04-4

Molecular formula:

C6H15NO

IUPAC Name:

2-[(butan-2-yl)amino]ethan-1-ol

Details on test material:

- Chemical name: 2-[(1-methylpropyl)amino]ethanol
- CAS number: 35265-04-4
- Batch number: A1V68M010101
- Expiration date of the test item: 28/01/11
- Appearance: colourless to yellow liquid
- Purity: 99.73 %

Results and discussion

In vivo

Results

Remarks on result:

other: Considered to be potentially corrosive, based on pH and alkaline reserve measurements

Any other information on results incl. tables

The definitive titration was performed 3 times in the following conditions :

A 10 mL volume of a 100 g/L solution is titrated by 0.1 N HCl under permanent pH measurement .

The data and graphs obtained are shown in annex 2.

Replicates gave following results :

Table 1:Results of neutralization experiments

Replicate	2-[(1-methylpropyl)amino]ethanol 100 g/L, mL	HCl 0.1 N, mL	Initial pH	Final pH	R*	Log(R)	I**
1	10	84.85	11.88	6.98	30.934	1.490	13.370
2	10	84.80	11.88	6.96
3	10	84.60	11.88	7.00

*R is the acidic/alkaline reserve, expressed as number of grams of pure acid (or base) to neutralise 100 g of test item.

** I is the physical-chemical index defined as follows : I = pH + log R when pH is >= 7

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

According to the method, the test item is considered as potentially severely irritant to the eye if at least 2 of the 3 following criteria are fulfilled:
· pH ≤ 2.5 or pH ≥ 9.5
· log R ≥ 0
· I ≥ 9

Executive summary:

To evaluated the potential corrosivity for the eye of sec-Butyl aminoethanol (Gancet, 2009), the pH and acidic/alkaline reserve was measured according to the method described by Regnier and Imbert (ATLA, 1992, 20, 457-465) and Froment (Arkema unpublished data, 1993). Under the test conditions, the results are as follow:

Test item	pH	log R (acidic/alkaline reserve	Physical-chemical index (I) I = pH + log R, for pH ≥7 I = (14 -pH) + log R, for pH < 7
2-[(1-methylpropyl)amino]ethanol	11.88	1.490	13.37

According to the method, a substance is considered as potentially corrosive to the eye if at least 2 of the 3 following criteria are fulfilled:

pH≤ 2.5 or pH ≥9.5

log R ≥ 0

I≥ 9

sec-Butyl aminoethanol is considered as potentially corrosive to the eye.