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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: Draize Test
Primary irritation to the skin is measured by a patch-test technique on the abraded and intact skin of albino rabbits.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3-di-o-tolylguanidine
EC Number:
202-577-6
EC Name:
1,3-di-o-tolylguanidine
Cas Number:
97-39-2
Molecular formula:
C15H17N3
IUPAC Name:
1,3-di-o-tolylguanidine

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
no data

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: abraded and intact skin
Vehicle:
unchanged (no vehicle)
Remarks:
undiluted
Controls:
no
Amount / concentration applied:
An amount of 500 g of DOTG
Duration of treatment / exposure:
24 hour(s)
Observation period:
24, 48 and 72 hours after application
Number of animals:
12 rabbits : 6 with intact skin, and 6 with abraded skin.
Details on study design:
DOTG is brought on the intact or abraded skin under a surgical patch measuring 1 inch x 1 inch. The patches are fixed to the application site by means of adhesive tape and the entire trunk of the rabbits is wrapped with an impervious material to maintain the test patch in position.
Twenty four hours prior to applying the materials, the hair is removed from the backs of the animals with an electric clipper in such a way as to avoid abrasions.
SCORING SYSTEM: Draize grading system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
12 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
(with intact and abraded skin)
Irritation parameter:
edema score
Basis:
mean
Remarks:
12 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
(with intact and abraded skin)
Irritant / corrosive response data:
No signs of skin irritation could be detected in any of the test animals, either at the end of the 24 hours application period or 48 hours later.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
not skin irritating according to CLP
Conclusions:
According to this study, DOTG is not a skin irritant in rabbits.
Executive summary:

DOTG was examined for possible skin irritating properties in rabbits.

DOTG was applied to rabbit during 24 hours and animals were observed at 1, 24, 48, 72 hours.

Primary irritation to the skin is measured by a patch-test technique on the abraded and intact skin of albino rabbits.

No signs of skin irritation could be detected in any of the test animals, either at the end of the 24 hours application period or 48 hours later.

DOTG did not cause any signs of skin irritation.