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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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.

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