Amines, N-C16-22-alkyltrimethylenedi-

Endpoint summary

Description of key information

Results of reserve alkaline test and testing conducted on analogue compounds lead to classify Amines, C16 -22 -alkyltrimethylenedi- as corrosive to the skin cat. 1B. and for serious eye damage cat.1.

Exposure to via the inhalation route will be unlikely to occur. Consequently, despite the irritant nature of the substance, respiratory irritation is not expected

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:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Qualifier:

no guideline available

Principles of method if other than guideline:

The method used in the study which permits the measurement of pH and Alkaline reserve to identify chemicals potentially corrosive to the skin and to the eye was described in V.Froment (1993) and JF.Regnier & C. Imbert (1992), respectively.

GLP compliance:

yes (incl. QA statement)

Strain:

not specified

Irritation / corrosion parameter:

other: Physical-chemical index (I) corrected

Value:

12.55

Vehicle controls validity:

not applicable

Negative controls validity:

not applicable

Positive controls validity:

not applicable

Irritation / corrosion parameter:

other: log R corrected

Value:

1.15

Vehicle controls validity:

not applicable

Negative controls validity:

not applicable

Positive controls validity:

not applicable

Irritation / corrosion parameter:

other: pH

Value:

11.4

Vehicle controls validity:

not applicable

Negative controls validity:

not applicable

Positive controls validity:

not applicable

Remarks on result:

positive indication of irritation

Under the test conditions, the aqueous substance shows a basic character demonstrated by a pH of 11.40 for a 100 g/L solution in water, an alkaline reserve of 14.18 (i.e log R = 1,15) and a physicochemical index of 12.55.

 

 

Table 1 : Results of neutralization experiments

 

Replicate	Dinoram 42 100 g/L, mL	HCl 0,5 N, mL	Initial pH	Final pH	Rcorrected	Log (R)  corrected	I
1	20	14.355	11.40	7.00	14.18	1,15	12.55
2	20	14.100	11.40	7.00
3	20	13.500	11.40	7.00

Interpretation of results:

corrosive

Conclusions:

The test item can be considered as potentially corrosive to the skin and severely irritant to the eye

Executive summary:

The acid/alkaline reserve method can be used at first step of stepwise strategy for assessing cutaneous and ocular irritation.
An amount of the test substance is added to distilled water in a beaker. The solution or suspension is maintained for 4 hours with agitation at 37° C. The pH is directly measured and the sample is then titrated with hydrochloric acid until neutrality is obtained. The acidic or alkaline reserve (R) is expressed as the number of grams of pure acid or base necessary to neutralise 100 g of product (%).
A preliminary titration was performed for a preliminary test to allows good conditions for the alkaline reserve (R) determination: 10 mL volume of a 100 g/L solution are neutralised by approximately 95 mL of 0.5 N HCl. Then for a definitive test, the titration were performed three times more in the same conditions.

Under the test conditions, the aqueous test substance shows an basic character demonstrated by a pH of 11.40 for a 100 g/L solution in water, an alkaline reserve of 14.18 (i.e log R = 1,15) and a physicochemical index of 12.55.

According to the method described, as all the criteria are fulfilled, the test item can be considered as potentially corrosive to the skin and severely irritant to the eye.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Reserve alkaline test

The dermal and ocular irritant potential of Amines, N-C16-22-alkyltrimethylenedi- was assessed using a non-animal testing based on alkaline reserve according to the method described in the two references : JF.Regnier and C.Imbert (1992), and V.Froment (1993).

This method can be used at first step of stepwise strategy for assessing cutaneous and ocular irritation.

An amount of the test substance is added to distilled water in a beaker. The solution or suspension is maintained for 3 hours with agitation at 37° C. The pH is directly measured and the sample is then titrated with diluted sodium hydroxyde or hydrochloric acid until neutrality is obtained. The acidic or alkaline reserve (R) is expressed as the number of grams of pure acid or base necessary to neutralise 100 g of product (%).

Under the test conditions, the aqueous Amines, N-C16 -22 -alkyltrimethylenedi- shows a basic character demonstrated by a pH of 11.40 for a 100 g/L solution in water, an alkaline reserve of 14.18 (i.e log R = 1.15) and a physicochemical index of 12.55.

According to the method described, as all the criteria are fullfilled, Amines, C16 -22 -alkyltrimethylenedi- can be considered as potentially corrosive to the skin and severely irritant to the eye.

 

All available data on the category of the diamines, indicate that all other besides this hydrogenated tallow-diamine are corrosive to skin, and classified as corrosive Cat. 1B (See table):

C12-14, Coco, Oleyl: as can be seen, C12-14, Coco and Oleyl diamines are all corrosive following 3 minute exposures, with in depth skin destruction only becoming visible at 24 hr readings, resulting to Cat.1B classification.

Tallow: for the Tallow, the 3 minute exposures do not lead to corrosion, but as the 1 hr exposure leads to corrosion, it still classifies as Cat. 1B. The Tallow seems to be a little less corrosive compared to the shorter chains and Oleyl. Unfortunately this substance has not been included in the BSL testing program at the time, so direct comparison of results is a bit less clear. It should be remarked that contrary to the recent BSL studies, the skin was decontaminated immediately after exposure. However, the same was done in the CESIO studies at SPL for Coco where the 3 minute exposures still resulted to corrosion.

HT: contrary to the other diamines the HT is not corrosive, but severely irritating. However, in view of the overall information on the category of alkyl-diamines, it is best to take care to limit possible dermal exposures.

 

Chain	Class	Study	Result
C12-14	Cat. 1B	BSL 073802C, 2008	3 min: Corrosive after 24 hrs
Coco	Cat. 1B	BSL 073802B, 2008	3 min: Corrosive after 24 hrs
	Cat. 1B	SPL 1594-191/1-18, 1989	3 min: Corrosive (skin decontaminated) effects indicative for corrosion were visible from 24 hours; 1/6 animals showed scar after 14 days
	Cat. 1B	SPL, Cesio, 1991	3 min: Corrosive (skin decontaminated) Scar tissue in 3/6 animals after 14 days, effects indicative for corrosion were visible from 24 hours
	n.a.	F&D Res.Lab, SD-1684, 1981	24 hrs: Corrosive (Eschar formation (dead skin) visible at 24 and 72 hrs. No later observations)
Oleyl	Cat. 1B	BSL 073802E, 2008	3 min (liquid/paste): Corrosive after 24 hrs
	Cat. 1B	BSL 073802A, 2008	3 min (liquid): Corrosive after 24 hrs
	Cat. 1B	CIT 19300 TAL, 2000	3 min (liquid): Corrosive (Crusts tissue from 24 hrs)
Tallow	Cat. 1B	SPL 116/28, 1987	(Diamine BG) 3 min: Irritant (skin decontaminated) 1 hr: Corrosive
	Cat. 1B	SPL 1594-191/1-18, 1989	3 min: Irritant (skin decontaminated) 1 hr: Corrosive
	n.a.	SPL, Cesio, 1991	3 min: Irritant (skin decontaminated)
HT	Cat. 2	BSL 073802D, 2008	4hr: Strongly irritating. Eschar formation was observed after 24h (animal 1) or after 48h (animal 2 and 3), fully reversible by day 9 or 14.
	Cat. 2	SPL 116/37, 1988	4hr: Irritating: at end of observation: dry straw-coloured

 

 

Eye irritation:

Due to the corrosive response expected on skin it is not ethical to carry out an animal study. In view of the severe reactions to skin, serious eye damage is to be expected.

 

Respiratory irritation:

Amines, N-C16 -22 -alkyltrimethylenedi- is a solid (pellets) with mp of 48°C and has a vapour pressure less than 0.0015 Pa at 20°C (value based on read-across from shorter chain C12-14-diamine). 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. Consequently, despite the irritant nature of the substance, respiratory irritation is not expected.

 

Justification for classification or non-classification

The results of reserve alkaline test indicate that Amines, C16 -22 -alkyltrimethylenedi- can be considered as potentially corrosive to the skin and severely irritant to the eye. The available studies for N-(hydrogenated tallow alkyl) trimethylenediamine (CAS 68603-64-5) show that this substance should regarded as a severe irritant as eschar formation (reversible) was observed in all treated animals. Consequently, a GHS classification corrosive Cat.1B. is appropriate for Amines, C16 -22 -alkyltrimethylenedi-, with hazard statement H314: Causes severe skin burns and eye damage.

In view of the severe irritant properties, it is prudent to classify the substance for serious eye damage Cat. 1, with hazard statement H318: Causes serious eye damage.

 

STOT-SE Cat.3 for respiratory irritation is not required. Exposure to via the inhalation route will be unlikely to occur. Consequently, despite the irritant nature of the substance, respiratory irritation is not expected