2-dibutylaminoethanol

Endpoint summary

Description of key information

- Skin irritation: corrosive 
- Eye irritation: severe damage
- Respiratory irritation: May be irritating / corrosive to respiratory tract.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Skin irritation:

In a dermal irritation study (BASF, No XVII/143, 1967), Vienna White rabbits (2 animals for each exposure period) were dermally exposed to the unchanged test substance for 1, 5, 15 min or 20 hours under occlusive conditions. Animals then were observed for 8 days. The original grading was converted into the numerical grading according to Draize. Exposure times of 1 and 5 min caused slight reddening (score 1) of the dorsal rabbit skin in one animal which was fully reversible within 8 days. Exposure time of 15 min caused reddening in both animals (score 1 and 2, respectively) which was not reversible within 8 days in one animal. Grey-brown full thickness necrosis was observed in the 20 h exposure experiment 24 hours after application. Necrosis stayed until the end of the observation period on day 8 and was accompanied by bleeding.

In a second dermal irritation study (BASF, No XV/127, 1965), Vienna White rabbits (2 animals for each exposure period) were dermally exposed to the unchanged test as described in the first dermal irritation study. Exposure times of 5 min caused slight reddening (score 1) of the dorsal rabbit skin in one animal after 24 h which was fully reversible within 8 days. Exposure time of 15 min caused reddening in both animals after 24 h (score 3 and 1, respectively) which was not reversible within 8 days in one animal (still score 2). Leathery, brown-red or grey-red full thickness necrosis was observed in the 20 h exposure experiment 24 hours after application. Necrosis stayed until the observation period of 8 days

Primary skin irritation on rabbits was recorded in a 10 grade ordinal series and was based upon the severest reaction that developed on the clipped skin of each of five albino rabbits within 24 hours of the uncovered application of 0.01 mL of undiluted test substance sample or of solutions (vehicle not further specified: water, propylene glycol, or acetone). No further information on method was given. The study led to Grade 6 of 10 which indicated necrosis when administered undiluted (Smyth et al., 1954).

In addition, in the Occupational Safety and Health Guidelines for Chemical Hazards (Supplement IV-OHG, 1995) of National Technical Information Service was noted that exposure to 2-dibutylaminoethanol caused irritation of the eyes, nose, throat, and skin in humans. However, no further information was provided.

Taking all findings together the results refer to a corrosive potential of the test substance.

Eye irritation:

In a primary eye irritation study (BASF, No XVII/143, 1967), 0.05 µL of the unchanged test substance was instilled into the conjunctival sac of the eye of each of two Vienna White rabbits (without washing). Animals then were observed for 8 days. The original grading was converted into the numerical grading according to Draize. The test substance caused corneal opacity (mean of 2 animals (24 - 48 - 72 h): 1.35) which was not reversible within 8 days in 1 animal (still score 3). Conjunctival redness (mean of 2 animals (24 - 48 - 72 h): 2.65) was also observed which was not reversible within 8 days in both animals. Chemosis was noticed (mean of 2 animals (24 - 48 - 72 h): 1.65) and was reversible within 8 days. Iritis was seen after 72 h in both animals (score 1) and on day 8 in 1 animal (score 2). Additionally, bleedings of the mucous membrane were observed in both animals at the 24 and 48 h readings.

In a secondary primary eye irritation study (BASF, No XV/127, 1965) which was conducted as the first primary irritation study, the test substance caused corneal opacity (mean of 2 animals (24 - 72 h): 1), conjunctival redness (mean of 2 animals (24 - 72 h): 1.25), chemosis (mean of 2 animals (24 - 72 h): 0.25) and iritis (mean of 2 animals (24 - 72 h): 0.25). All effects were fully reversible within 8 days.

Eye injury in rabbits (strain unknown) was recorded in a 10 grade ordinal series and was based upon the degree of corneal necrosis that results from instillation of various volumes and concentrations of the test substance. 24 h after instillation the eyes were observed for gross evidence of injury. No further information on method was given. The study led to Grade 5 of 10 which indicated a so-called severe burn from 0.005 mL undiluted test substance (Smyth et al., 1954).

In addition, in the Occupational Safety and Health Guidelines for Chemical Hazards (Supplement IV-OHG, 1995) of National Technical Information Service was noted that exposure to 2-dibutylaminoethanol caused irritation of the eyes, nose, throat, and skin in humans. However, no further information was provided.

Due to these results and the corrosive potential of the test substance on the skin, it can be concluded that the test substance also causes severe damage to eyes.

Respiratory irritation:

There is no data concerning respiratory irritation besides the note in the Occupational Safety and Health Guidelines for Chemical Hazards (Supplement IV-OHG, 1995) of National Technical Information Service that exposure to 2-dibutylaminoethanol caused irritation of the eyes, nose, throat, and skin in humans. In the Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening (BASF SE 2013, inhalation exposure) the local NOAEC was set at the lowest dose level (20.6 mg/m³) due to histopathologic lesions of nasal epithelia. Regarding these findings and data on corrosivity to the skin and eyes, irritation / corrosion to the respiratory tract cannot be excluded.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the data, classification concerning corrosivity (C, R34) is warranted.

 

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification concerning corrosivity (Cat. 1C) and may cause respiratory irritation (STOT SE 3) is warranted.