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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: no details given, nevertheless it can be taken for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Principles of method if other than guideline:
Method: 6 animals, clipped areas of the back (intact skin), 0.5 ml undiluted test material/animal, 24 h, semiocclusive, reading time: at removal and after 48 h.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
m-toluidine
EC Number:
203-583-1
EC Name:
m-toluidine
Cas Number:
108-44-1
Molecular formula:
C7H9N
IUPAC Name:
3-methylaniline
Test material form:
other: liquid
Details on test material:
IUCLID4 Test substance: other TS: m-toluidine, purity: >98.5%

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
no data

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 ml undiluted test material
Duration of treatment / exposure:
24 hours
Observation period:
up to 48 hours post initial application
Number of animals:
6
Details on study design:
Albino rabbits were clipped free of hair on the trunk and lateral area and were placed in FDA-type stocks. Doses of 9.5 ml of undiluted test material was applied to intact skin under gauze squares. Rubber sheeting was loosely wrapped around the treated area, secured with adhesive tape. After 24 hours the rabbits were removed from the stocks, the patches taken off and the reactions observed. Observations were also made at 48 hours.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: erythema and edema
Basis:
other: --erythema: mild in 5/6 rabbits and slight in 1/6 rabbits; --no edema in 6/6 rabbits
Time point:
other: 24 hours
Reversibility:
other: see observation time point 48 hours
Remarks on result:
other: scores not available
Irritation parameter:
other: erythema and edema
Basis:
other: slight erythema in 6/6 rabbits but none of 6/6 rabbits show edema
Time point:
other: 48 h
Remarks on result:
other: scores were not given
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at 24 and 48 hrs.
Remarks on result:
other: no edema was observed during the 48 hour observation time
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at 48 hours
Remarks on result:
other: no edema was observed during the 48 hour observation time
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
4
Reversibility:
other: not measured/tested
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
>= 0
Max. score:
4
Reversibility:
other: 48 hours. slight erythema in 6/6 rabbits
Remarks on result:
other: 24 hours: mild erythema in 5/6 rabbits and slight erythema in 1/6 rabbits
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
>= 0
Max. score:
4
Reversibility:
other: 48 hours. slight erythema in 6/6 rabbits
Remarks on result:
other: 48 hours. slight erythema in 6/6 rabbits
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
4
Reversibility:
other: not measured/tested
Remarks on result:
not measured/tested
Irritant / corrosive response data:
24 hours: mild erythema in 5/6 rabbits and slight erythema in 1/6 rabbits
48 hours: slight erythema in 6/6 rabbits
no edema was observed during the 48 hour observation time
Other effects:
24 hours: mild erythema in 5/6 rabbits and slight erythenma in 1/6 rabbits
48 hours. slight erythema in 6/6 rabbits
no edema was observed during the 48 hour observation time

Any other information on results incl. tables

m-Toluidine produced slight-mild skin irritation in 24 hours and slight skin irritation in 48 hours when tested on shaved intact skin of rabbits and was not fully reversible in this 48 hour observation time.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

When applied to the clipped intact skin of the back of rabbits undiluted m-toluidine produced mild to slight skin irritation in 24 hours and slight skin irritation in 48 hours. Due to the short observation time of 48 hours the slight effects were observed throughout the entire observation period but are not relevant for classification (DuPont De Nemours 1980).