Amines, N-C16-22-alkyltrimethylenedi-

Skin irritation / corrosion

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

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)

Test material

Test material information

Constituent 1

Reference substance name:

Amines, N-C16-22-alkyltrimethylenedi-

EC Number:

292-564-1

EC Name:

Amines, N-C16-22-alkyltrimethylenedi-

Cas Number:

90640-45-2

Molecular formula:

R-NH-(CH2)3-NH2 R = alkyl mainly C16-22-(even numbered)-alkyl

IUPAC Name:

Amines, N-C16-22-alkyltrimethylenedi-

Test material form:

solid

Details on test material:

Chemical registery number : 292-564-1
Chemical name : Amines, N-C16-22-alkyltrimethylenedi-

Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agree by each registrant.

Test animals

Strain:

not specified

Results and discussion

In vitro

Results

Results 1

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

Results 2

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

Results 3

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

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.