2-[[3-(dimethylamino)propyl]methylamino]ethanol

Endpoint summary

Description of key information

Skin irritation / corrosion:

- Skin corrosive, Cat. 1B [based on results of a reliable study equivalent or similar to OECD Guideline 404 for the substance 2-[[3-(dimethylamino)propyl]methylamino]ethanol].

- Results are as expected, given that the substance is a strong base (pH=12); as the available information indicates that the substance needs to be classified as skin corrosion Category 1B, there would actually have been no need to conduct a study.  

Eye irritation:

- Serious eye damaging, Cat. 1 [based on the classification of the substance 2-[[3-(dimethylamino)propyl]methylamino]ethanol as skin corrosive (sub-category 1B; H314)].

- The available experimental data of the study equivalent or similar to OECD Guideline 405 for 2-[[3-(dimethylamino)propyl]methylamino]ethanol would not be sufficient to classify the substance, but this is not required as the substance is classified as skin corrosive (sub-category 1B; H314); such a substance is automatically considered to be severely damaging to the eye and is classified but not labelled for serious eye damage in addition to skin corrosion. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 August 1980 (started); 30 September 1980 (reported)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: study report provides basic data, but some details missing including type of coverage, duration of treatment, individual animal data and scoring system

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Remarks:

study was conducted before implementation of GLP

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

weight at study initiation: 2.82 kg (mean)

Type of coverage:

not specified

Preparation of test site:

other: abraded skin (3 animals), intact skin (3 animals)

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

2.0 mL/animal

Duration of treatment / exposure:

4 hours (not documented)

Observation period:

30 days

Number of animals:

6 total (3 male with intact skin, 3 male with abraded skin)

Irritation parameter:

other: overall corrosion

Basis:

mean

Reversibility:

other: reversible within 30 days

Remarks on result:

other: severe corrosion in all animals (with abraded and intact skin)

Irritation parameter:

other: overall erythema

Basis:

mean

Reversibility:

other: reversible within 30 days

Remarks on result:

other: severe erythema in all animals (with abraded and intact skin)

Irritant / corrosive response data:

scores (including the reversibility of the effects observed) for individual animals: not available

Table: Irritant/corrosive response data for each male rabbit

	Erythema	Edema	Corrosion
Animal #1 (intact skin)	severe (reversible within 30 days)	-	severe (reversible within 30 days)
Animal #2 (intact skin)
Animal #3 (intact skin)
Animal #4 (abraded skin)	severe (reversible within 30 days)	-	severe (reversible within 30 days)
Animal #5 (abraded skin)
Animal #6 (abraded skin)

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

corrosive to rabbit skin (6 of 6 test animals)

Executive summary:

In a primary dermal irritation study (equivalent or similar to OECD guideline 404, prior to introduction of GLP), 6 male New Zealand White rabbits - half with shaved, the other half with abraded skin - were dermally exposed to 0.2 mL of the undiluted test material 2-[[3-(dimethylamino)propyl]methylamino]ethanol (most likely for 4 hours under an occlusive bandage). 

Animals were observed post dosing for erythema, edema and corrosion. 

The undiluted test substance caused severe erythema and severe corrosivity in all animals, but the effects observed were fully reversible within the observation period of 30 days in all treated animals.

Although data on individual animals are missing and no information about the scoring system is available, the study is considered sufficient for classification and hazard identification on the basis of the unambiguous test results: in this study, severe corrosivity occured in 6 of 6 test animals. 

The available information indicates that the substance 2-[[3-(dimethylamino)propyl]methylamino]ethanol, being a strong base (pH=12), needs to be classified as Skin Corr. 1B [using the EU Globally Harmonised System (GHS)].

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Skin irritation

Based on the results of a reliable study equivalent or similar to OECD Guideline 404, the substance 2-[[3-(dimethylamino)propyl]methylamino]ethanol, being a strong base (pH=12), meets the criteria for classification and labelling for this endpoint, as set out in Regulation (EC) No. 1272/2008: Category 1B; H314.

Eye irritation

The substance 2-[[3-(dimethylamino)propyl]methylamino]ethanol is classified as skin corrosion (sub-category 1B; H314), leading to classification as serious eye damage (category 1; H318).