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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Remarks:
Patch Test according to Draize (1944)
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
Remarks:
comparable to guideline study with acceptable restriction; short observation periode (up to 72 h)
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1996
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: other: Patch Test according to Draize (1944)
GLP compliance:
not specified

Test material

Constituent 1
Details on test material:
other TS: Compound WTR 15 Nonox TBC (corresponding to Vulkanox KB)

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: six rabbits were treated on the intact skin, six rabbits on the abraded skin
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
24 hour(s)
Observation period:
24, 72 h
Number of animals:
6 per group
Details on study design:
see text field materials and methods

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Time point:
other: 24h and 72 h
Score:
>= 0.3 - <= 0.7
Max. score:
8
Reversibility:
not fully reversible within: 72 h, but a clear time dependent decrease was seen down to 0.3 within 72 h
Remarks on result:
other: very slight erythema (barley perceptible)
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
mean
Time point:
other: 24 h and 72 h
Score:
0 - <= 0.3
Max. score:
8
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: very slight edema (barely perceptible)
Irritant / corrosive response data:
see text field results
Other effects:
see text field results

Any other information on results incl. tables

After semi-occlusive application of test substance to the
intact and scarified skin, respectively, a very slight
irritation could be noted: Intact skin: erythema 3/6 (24 h);
2/6 (72 h), edema 1/6 (24 h); 0/6 (72 h); abraded skin:
erythema 1/6 (24 h); 0/6 (72 h), edema 1/6 (24 h); 0/6 (72
h)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
BHT caused very slightly skin irritation in 3/6 rabbits treated on the intact skin, and 1/6 rabbits treated on the abraded skin (Bomhard 1996).
Executive summary:

BHT caused very slightly skin irritation in 3/6 rabbits treated on the intact skin, and 1/6 rabbits treated on the abraded skin (Bomhard 1996).