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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

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.