Amines, N-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, N-(hydroxyethyl) derivs.

Endpoint summary

Description of key information

Available studies result to GHS classification Category 4 for acute oral toxicity (LD50 between 300 and 2000 mg/kg bw) with a LD50 cut-off of 500 mg/kg bw.

No data available on acute toxicity via inhalation or dermal route.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

500 mg/kg bw

Quality of whole database:

The study is GLP compliant and has Klimisch score 1

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Evaluation of the acute toxicity of Tris (2-hydroxyethyl) tallow diaminopropane, CAS 90367-27-4 (recently redefined as Amines, N-(C16-18 (even numbered) and C18-unsatd. alkyl) trimethylenedi-, ethoxylated (NLP), CAS 1290049-56-7), also referred to as Tallow-diamine3EO:

 

Oral

There are five studies available on alkyl-diamine3EO substances relevant for the evaluation of the acute oral toxicity of Tallow-diamine3EO. Of these, three studies are not reliable, but these also do not indicate that a more severe classification would be required.

For evaluation therefore, the following two studies are available:

 

The first study (selected key-study) evaluated the acute oral toxicity of Tallow-diamine3EO according to the guidelines for the acute toxic class method (OECD 423) performed under GLP.

In step 1 three male rats were dosed by oral gavage with 200 mg Tallow-diamine3EO/kg body weight in corn seed oil. Signs of toxicity observed werehypoactivity, piloerection and hypersalivation on days 1 and 2, and recovery was complete on day 3. However, on day observation day 14, one of the animals was found dead. At the next step 3 males were dosed 2000 mg/kg. All three animals were found dead on day 2. The last step an additional 3 females were also dosed at 200 mg/kg bw. No mortality occurred. All three animals showed hypoactivity and piloerection on days 1 and 2, together with dyspnoea on day 2. Then dyspnoea, together with swollen abdomen on days 3 and 4 or noisy breathing between days 12 and 14, was noted in 1/3 females from day 3 to day 5 and from day 12 to day 14. Body weights of surviving animals were not affected, and at necropsy, no apparent abnormalities were observed. Based on these results, the oral LD50 is between 200 and 2000 mg/kg. Because only 1 male out of 3 male and 3 female rats dosed at 200 mg/kg died on day 14, it is expected that the LD50 value is higher than 300 mg/kg bw but lower than 2000 mg/kg, and according to OECD 423 the LD50 cut-off = 500 mg/kgbw.

 

A second, older study on Tallow-diamine3EO that is available, was performed according a standard acute method. In this study 5 male rats were dosed0.313, 0.625, 1.25, 2.50 and 5.00 mL/kg bw. Mortality at 1.25 mL/kg bw was 4/5, and at 0.625 mL/kg bw 2/5. At 2.50 and 5.0 mL/kg all animals died within 3 days. At 0.313 mL/kg bw all five animals survived. At gross autopsy all animals dosed at levels above 0.313 mL/kg showed signs of gastric irritation, and upon cut section of the kidneys, congestion of renal tubules. The LD50 was calculated to be 770) mg/kg bw.

 

Overview of all available data.

Substance	Study	Validity	Results
Tallow-diamine3EO	OECD 423	1	LD50 cut-off 500 mg/kg - key study
Tallow-diamine3EO	OECD 401	2	LD50 770 mg/kg
Tallow-diamine3EO	OECD 401	3	(diluted formulated product) LD50 ca.2400 mg/kg
Tallow-diamine3EO	OECD 401	4	(Abstract - diluted formulated product) LD50 ca.410 mg/kg
Hydrogenated tallow-diamine3EO	OECD 401	4	(identity not indicated in report) LD50 = 860 mg/kg

 

 

Inhalation:

There is no study on inhalation toxicity available for Tallow-diamine3EO.

REACH stipulates that testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

REACH guidance (R.7.a, chapter. 7.4 Acute toxicity) indicates that in principle no inhalation studies are needed when vp < 0.1 Pa at 20°C or particle size > 100 µm.Tallow-diamine3EO is a (viscous) liquid with a vapour pressure less than 0.0015 Pa at 20°C. Also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur, and no acute inhalation test was performed.

 

Tallow-diamine3EOis not a pure aliphatic, alicyclic and aromatic hydrocarbons and has a relatively high viscosity (Kinematic viscosity 1163 mm2/s at 20 °C) and so do not indicate an immediate concern for aspiration hazard.

 

Dermal:

There is no data available from acute toxicity testing by dermal route forTallow-diamine3EO.

Tallow-diamine3EO is classified for skin corrosion Cat.1B. Due to the severe corrosive nature of the substance it is not ethical to carry out this animal study.

Toxicity following dermal exposure will be characterised by local tissue damage, rather than the result of percutaneously absorbed material. For these severe corrosive substances, the use of protective gloves and other equipment, such as face shields, aprons and good work practices are mandatory. Consequently, the occurrence of substantial dermal exposure of amounts comparable to the levels for acute oral toxicity is unlikely.

Justification for selection of acute toxicity – oral endpoint

Appropriate study of the highest quality and validity

Justification for selection of acute toxicity – inhalation endpoint

No inhalation studies are needed when vp < 0.1 Pa at 20°C or particle size > 100 µm. Tallow-diamine3EO is a (viscous) liquid with a vapour pressure less than 0.0015 Pa at 20°C.

Justification for selection of acute toxicity – dermal endpoint

An acute dermal toxicity study does not need to be conducted as the substance is classified as corrosive to the skin.

Justification for classification or non-classification

Oral LD50 is expected >= 300 mg/kg, and using an LD50 cut-off level of 500 mg/kgbw is appropriate. Tallow-diamine3EO therefore needs to be classified for acute toxicity according to GHS as Cat.4 with hazard statement H302 “harmful if swallowed”.

 

No data is available regarding acute toxicity by dermal route, but further testing is due to its severe corrosive properties not indicated.

 

Also no acute inhalation studies are available, and in view of lack of exposures no studies are indicated.

 

Tallow-diamine3EO is not a pure aliphatic, alicyclic and aromatic hydrocarbons and has a relatively high viscosity (Kinematic viscosity 1163 mm2/s at 20 °C) and so does not indicate an immediate concern for aspiration hazard.