Nitrilotriacetonitrile

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study is reported sufficeintly to understand what was done. Predates GLP. Study only designed to assess corrosivity

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: see below

Principles of method if other than guideline:

Guideline for corrosivity assay followed: The method employed is patterned after 21 CFR 191.11 as described in 49 CFR 173.240

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Nitrilotriacetonitrile

EC Number:

230-804-9

EC Name:

Nitrilotriacetonitrile

Cas Number:

7327-60-8

Molecular formula:

C6H6N4

IUPAC Name:

2-[bis(cyanomethyl)amino]acetonitrile

Details on test material:

White Crystalline powder
Purity >99%

Test animals

Species:

rabbit

Strain:

other: albino

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Remarks:

moistened with saline

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

48 hours

Number of animals:

5

Details on study design:

5 healthy, acclimated animals were shaved (back). 0.5 g of test material was applied under a 1 inch square gauze. An impervious rubber wrap was then applied to hold the material in place. Exposure duration was 4 hours and observations were made at the end of the 4 hours and then at 48 hours. No further observations were made.
Scores were assigned based on the scoring scale below.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 4 h

Score:

ca. 1

Max. score:

6

Reversibility:

other: see below

Remarks on result:

other: score of 1 was seen in 4 out of 5 animals

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 48 h

Score:

ca. 0.5

Max. score:

6

Reversibility:

other: at 48 h 2 out of 5 animals still showed slight erythema, no further observations were made

Irritant / corrosive response data:

In 4 out of 5 animals there was a slight erythema (grade 1 out of a possible 6) at 4 hours. At 48 hours this had dissapeared in 2 of those affected. No further observations were made.
No corrosivity was observed.

Applicant's summary and conclusion

Interpretation of results:

other: not-corrosive

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The substance was slightly irritating after a 4 hour exposure. No corrosivity was observed. Due to the minimal degree of irritation observed it is unlikely that this substance would meet the criteria for classification as a skin irritant.