2-[(1-methylpropyl)amino]ethanol

Endpoint summary

Description of key information

sec-Butyl aminoethanol is considered as potentially corrosive to the skin and the eyes and is irritating for the respiratory tract.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

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

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

no

GLP compliance:

no

Irritation / corrosion parameter:

other: other: Break through time (minutes)

Value:

40

Remarks on result:

other:

Remarks:

Remarks: Corrosive (packing group II, or Cat. 1B). (migrated information)

RESULTS OF PILOT STUDY:
Qualification screen allows CDS use.
Categorization screen allows using the following scoring scale:
Up to 3 minutes: Corrosive (Packing group I)
>3 min but <1h: Corrosive (Packing group II)
>1h but <4h: Corrosive (Packing group III)
>4h: No corrosive

RESULTS OF TEST
See Attached Document

Interpretation of results:

Category 1B (corrosive)

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

This in vitro test allows to consider 2-butylaminoethanol as corrosive with regard to biomembranes.

Executive summary:

According to a Corrositex continuous time monitor assay, 2-butylaminoethanol is considered as corrosive category 1B with regard to biomembranes.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

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

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)

Remarks on result:

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

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

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Skin and eye irritation

To evaluated the potential corrosivity for the skin and the eyes of sec-butylaminoethanol(Gancet, 2009a), 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). These measurements were also performed on an analogue substance, 2-n-butylaminoethanol (CAS no. 111-75-1), which can be used in a read-across (Gancet, 2009b).

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
sec-butylaminoethanol	11.88	1.490	13.37
2-n-butylaminoethanol	12.06	1.489	13.55

 

According to the method, both substances were considered as potentially corrosive to the skin and the eyes as at least 2 of the 3 following criteria are fulfilled:

- pH≤ 2.5 or pH ≥9.5

- log R ≥ 0

- I≥ 10 (for skin) or I≥ 9 (for eyes)

 

As sec-butylaminoethanol and 2-n-butylaminoethanol are both very alkaline subtances, with very similar values of pH and acidic/alkaline reserve, the results of a Corrositex continuous time monitor assay performed with 2-n-butylaminoethanol (Nims, 1995) are applicable to sec-butylaminoethanol which is therefore considered as corrosive to skin category 1B.

 

Respiratory tract irritation

 

In an 4-h acute inhalation toxicity study in rats (Schuler, 2012), sec-butyl aminoethanol exposure induced severe clinical signs of respiratory irritation in all animals.

 

Justification for selection of skin irritation / corrosion endpoint:
Test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Justification for selection of eye irritation endpoint:
Test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Effects on respiratory irritation: irritating

Justification for classification or non-classification

- According to CLP criteria

Skin corrosive category 1B, H314: Causes severe skin burns and eye damage

Eye irritant category 1, H318: Causes serious eye damage

STOT-SE category 3, H335: May cause respiratory irritation

- According to DSD criteria

C, R34 Causes burns

R37 Irritating to respiratory system