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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:
supporting study
Study period:
1962
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basis scientific principles, however the method does not comply to current requirements on limited details were available on materials and methods.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1962
Report Date:
1962

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
4 animals tested and evaluated after 48h and 5 days
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
human
Strain:
not specified
Details on test animals and environmental conditions:
Not applicable

Test system

Type of coverage:
occlusive
Preparation of test site:
other: swabbing with warm distilled water and dried
Vehicle:
other: neutral distilled water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A 1 cm2 of unmedicated white lint was soaked in the test solution, lightly blotted and applied to the skin.
- Concentration (if solution): Solutions were made in neutral distilled water so that in each instance the “active matter” content was maintained at levels of 5% and 10% for each test substance.

Duration of treatment / exposure:
48 hours
Observation period:
72 hours
Number of animals:
4 volunteers per test substance
Details on study design:
TEST SITE
- Area of exposure: outer surface of the left upper arm
- Type of wrap if used: waterproof adhesive dressing of some 4.5 cm diameter, the adhesive centre portion of which was covered with a circle of cellulose film of 2.2 cm diameter.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
other: individual scores
Time point:
other: 48 hours & 5 days
Score:
0
Irritant / corrosive response data:
No reactions were detected.

Any other information on results incl. tables

Table 1. Irritation

Subject

5% solution

10% solution

48 hours

5 days

48 hours

5 days

102

-

-

-

-

103

-

-

-

-

104

-

-

-

-

105

-

-

-

-

Result-No reaction detected

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
No reactions were detected.
Executive summary:

A 1 cm2 of unmedicated white lint was soaked in the 5 and 10% test substance solution in comparison with toilet soaps, and applied to the skin of the left arm of 4 volunteers for 48 hours under waterproof adhesive dressing, followed by an observation period of 72 hours. No reactions were detected.