Titanium(4+) ethanolate

Skin irritation / corrosion

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Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Determination of skin irritation potential in the human 4-h patch test

Author:

Basketter DA, York M, McFadden JP & Robinson MK

Year:

2004

Bibliographic source:

Contact Dermatitis 51, 1-4

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Human (up to) 4-hour covered patch-tests used to determine skin irritation potential of ethanol. Reaction to 20% SDS used as a comparative positive control.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Constituent 2

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:

Not further described

Test animals

Species:

human

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 ml

Duration of treatment / exposure:

Separate patches were applied progressively from 15 minutes, through 30 minutes, 1, 2, 3 and 4 hours. Each application was at a new skin site on the upper arm.

Observation period:

Treatment sites assessed at 24, 48 and 72 hours after patch removal.

Number of animals:

31 volunteers

Results and discussion

In vivo

Results

Irritation parameter:

other: semi-quantitative response as described above.

Basis:

other: number of positive responses from total number tested.

Time point:

other: 4 h

Reversibility:

no data

Remarks on result:

other: One volunteer presumably had a response determined to be + or greater, but no further details were given.

Other effects:

One of 31 volunteers had a positive reaction to ethanol compared to 15/31 of the SDS positive controls.

Any other information on results incl. tables

Read-across justifications and data matrices are presented in IUCLID section 13.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: The level of irritant reaction following treatment with ethanol was substantially and significantly lower than the response to the SDS treatment.

Conclusions:

Ethanol is not classifiable as to skin irritation. The results indicate that ethanol has only a very low potential to irritate the skin of humans.

Executive summary:

Up to 4 -hour covered skin patch tests were conducted in 31 volunteers using 0.2 ml neat ethanol. A reaction determined to be indicative of irritation (+ or greater, on a scale of 0, +, ++, or +++) was seen in just one individual. 15 of the 31 volunteers reacted to similar patches with 20% sodium dodecyl sulfate (SDS). The results indicate that ethanol has, at most, just a very low potential to irritate the skin of humans.