1,3-di-o-tolylguanidine

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:

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

Test material information

Constituent 1

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

Results

Results 1

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)

Results 2

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.