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Toxicological information

Skin irritation / corrosion

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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).