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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
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Citet in OECD SIDS. Acceptable, study with sufficient basic documentation to demonstrate that study meets basic scientific principles and contains enough detail to be able to judge the results reliable as a supporting study.

Data source

Reference
Reference Type:
publication
Title:
A comparison of rabbit and human skin response to certain irritants.
Author:
Phillips, L. II., Steinberg, M., Maibach, H.J., Akers, W.A.
Year:
1972
Bibliographic source:
Toxicol Appl Pharmacol 21:369-382.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: Draize protocol
Deviations:
yes
Remarks:
see below
Principles of method if other than guideline:
The test method was a modification of the Draize 1944 protocol to make it suitable for use with humans but using repeated daily occluded applications over a sub-acute period.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethanol
EC Number:
200-578-6
EC Name:
Ethanol
Cas Number:
64-17-5
Molecular formula:
C2H6O
IUPAC Name:
ethanol
Details on test material:
- Name of test material (as cited in study report): Other TS
- Analytical purity: Test compound was 95% ethanol. It is assumed that this is doubly rectified material, in which case the remainder is 5% water.

Test animals

Species:
human

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.2ml
Duration of treatment / exposure:
21 days or until a grade 4 reaction seen.
Observation period:
Readings taken daily when patch removed before re-application of next daily dose.
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: paraspinal location on subject's back, clipped 24 hours prior to testing
- % coverage: 2x2cm areas, 11 per subject )5 one side, 6 the other
- Type of wrap if used: Patches of non-woven fabric (Webril) impregnated with test material then occluded with Blenderm impermeable tape.

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

SCORING SYSTEM: Scoring done 30 mins after patch removal. Scoring system used was:
0=no reaction
+/- = questionable erythema not covering entire patch
1=definite erythema over whole patch
2=erythema and induration
3=vesiculation
4=bullous reaction

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: cumulative score
Score:
10
Max. score:
80
Reversibility:
no data

Any other information on results incl. tables

Daily scores

 Days  Score
 1 -12
 13, 14 +/- 
 15 -18  1
 19 -21  2
Day 7 also had a score of +/-

Applicant's summary and conclusion

Interpretation of results:
other: slightly irritating under extreme repeat dose situations
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
Direct comparison of the results against the EU classification criteria is not possible. There is evidence that under repeat dose exposure skin irritation can eventually occur.
On the other hand - In the form of biocidally active surgical spirit (70-80% ethanol in water), there is a considerable history of dermal application of ethanol as an antiseptic with no concern for skin irritancy. Similarly, large amounts of ethanol are used in a variety of cosmetics, personal care and household cleaning products.
Executive summary:

In a study that was designed to assess the potential for skin irritation under severe repeated dose conditions, ethanol was applied under occlusive conditions to the skin (backs) of male human volunteers. The application was repeated daily and the response checked from the previous dose before each fresh application. No irritation was seen until day 13, after which the irritative response slowly increased, initially as erythema until by day 19 erythema plus induration were also seen. The study was halted on day 21.