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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Justification for type of information:
Animal testing pre-dates availablity of valid in-vitro methods

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Appraisal of the Safety of Chemicals in Food, Drugs and cosmetics (1959), the US Association of Food and Drug Officials (AFDO)
Principles of method if other than guideline:
The procedure used was the patch test technique described in the above guideline.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-o-tolylbiguanide
EC Number:
202-268-6
EC Name:
1-o-tolylbiguanide
Cas Number:
93-69-6
Molecular formula:
C9H13N5
IUPAC Name:
1-o-tolylbiguanide

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 - 2.0 Kg
- Housing: housed individually in metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): constant room temperature of 18 +/- 1° C
- Humidity (%): 55 +/- 5 %
- Photoperiod (hrs dark / hrs light): 10 hours dark / 14 hours light

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
not specified
Controls:
not specified
Duration of treatment / exposure:
The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour exposure.
Observation period:
The skin irritation was scored immediately and 48 hours after removal of the dressings (24 and 72 hours after initiation of treatment)
Number of animals:
6 (3 male, 3 female)

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
ca. 0.2
Max. score:
2
Reversibility:
fully reversible
Irritant / corrosive response data:
Only limited details were avbailable, but conclusion considered to be reliable in that the substance is only slightly irritant.

Any other information on results incl. tables

The skin irritation was scored immediately and 48 hours

after removal of the dressings   (24 and 72 hours after initiation of treatment)• Skin irritation was scored in accordance with the irritation score from table 1.

The severity of skin irritation was rated as follows: A mean value of less than 2 indicated mild, from 2 to 5 moderate and above 6 severe skin irritation.

Score for skin irritation in rabbits (Table 1)

Erythema and eschar formation

No erythema....................................0

Very slight erythema (barely perceptible)......1

Well defined erythema..........................2

Moderate to severe erythema.................. 3

Severe erythema (beet redness) to slight eschar

formation (injuries in depth)............... 4

Maximum possible erythema score

Edema formation

No edema..................................... 0

Very slight edema (barely perceptible)....... 1

Slight edema (edges of area well defined by

definite raising)............................ 2

Moderate edema (raised approximately 1 mm)... 3

Severe edema (raised more than 1 mm and

extending beyond area of exposure)........... 4

Maximum possible edema score4

Results - Table 2

The primary irritation index is the mean value of the sum of the scores for erythema and edema from all 6 rabbits 24 and 72 hours after initiation of treatment. The maximum possible score is 8.

The primary skin irritation index in this experiment was established to be 0.2.

Skin irritation in individual rabbits - Table 2

Animal No. Sex Skin Reaction 24 hrs after application 72 hrs after application
intact skin scarified skin intact skin scarified skin
1♂ Erythema 0 1 0 0
Edema 0 0 0 0
2♂ Erythema 0 0 0 0
Edema 0 0 0 0
3♂ Erythema 0 1 0 0
Edema 0 1 0 0
4♀ Erythema 0 1 0 0
Edema 0 0 0 0
5♀ Erythema 0 0 0 0
Edema 0 0 0 0
6♀ Erythema 0 0 0 0
Edema 0 0 0 0


Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Average score of 0.2 suggests the material is not irritating to skin.