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Description of key information

Skin irritation: Key study: Patch Test according to Draize (1944). 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).

Eye irritation: Key study: Draize test according to  Draize and Kelly (1952). Transient slight conjunctivitis was seen one day after administration of BHT. The symptoms were completely reversible after 72 h (Bomhard 1996).



Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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)
Reason / purpose for cross-reference:
reference to same study
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: other: Patch Test according to Draize (1944)
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
no data
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
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
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)
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).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Remarks:
Draize test according to Draize and Kelly (1952)
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 restrictions; short observation periode (up to 72 h).
Reason / purpose for cross-reference:
reference to same study
Principles of method if other than guideline:
Method: other: Draize test according to Draize and Kelly (1952), Drug Cosmet. Industr. 71, 36 and FDA (1963), Fed. Reg. 28, 119, 5582
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no data
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
undiluted
Amount applied: 100 other: mg
Duration of treatment / exposure:
whole observation period
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Details on study design:
see text field materials and methods
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no ulceration or opacity
Remarks on result:
other: no ulceration or opacity
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 72h
Remarks on result:
other: fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48h
Remarks on result:
other: fully reversible
Irritant / corrosive response data:
see text field results
Other effects:
no data
6 of 6 rabbits showed slight conjunctivitis after 24 hours.
Symptoms were completely reversible after 72 hours.
Interpretation of results:
GHS criteria not met
Conclusions:
Transient slight conjunctivitis was seen one day after administration of BHT. The symptoms were completely reversible after 72 h (Bomhard 1996).
Executive summary:

Transient slight conjunctivitis was seen one day after administration of BHT. The symptoms were completely reversible after 72 h (Bomhard 1996).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the available data, the substance is not classified as skin irritant or eye irritant.