Registration Dossier

Administrative data

Description of key information

Key studies: Read-across from experimental data on the analogue 2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across from an analogue substance for which a guideline study (Klimisch 2) is available.
Reason / purpose for cross-reference:
read-across source
Principles of method if other than guideline:
Read-across from company data on an analogue.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Based on a read-across from an analogue substance.
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Based on a read-across from an analogue substance
Interpretation of results:
GHS criteria not met
Conclusions:
In a 4 hour rabbit skin irritancy test, the test material (source chemical) caused no skin reactions and is therefore not a skin irritant. The read across approach is applied and the target chemical BHT is considered to be non-irritant for the skin.
Executive summary:

The analogue CAS No. 118-82-1 (2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol) which shares the same functional group (alkylphenol) with the substance CAS no. 128-37-0 (2,6-di-tert-butyl-p-cresol), also has comparable values for the relevant molecular properties. Therefore, the results obtained with the substance CAS No. 118-82-1 can be used for the read-across approach.

Based on company data, the read-across approach is applied from 2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol and the substance 2,6 -di-tert-butyl-p-cresol (BHT) is considered to be non-irritant for the skin.

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation, other
Remarks:
read-across from supporting subtance
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across from an analogue substance for which a guideline study (Klimisch 2) is available.
Reason / purpose for cross-reference:
read-across source
Principles of method if other than guideline:
Read-across from company data on an analogue
GLP compliance:
yes
Remarks on result:
other: Read across, see cross reference to source information

The results are presented in the cross reference to the source information (read-across).

Interpretation of results:
GHS criteria not met
Conclusions:
In the rabbit eye irritancy test, the test material (source chemical) caused slight conjunctival redness within 1 hour of dosing which had cleared by 24 hours. The test material is therefore not an eye irritant in rabbits. The read across is applied and the target chemical BHT is considered to be non-irritant for the eyes.
Executive summary:

The analogue CAS No. 118-82-1 (2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol)which shares the same functional group (alkylphenol) with the substance CAS no. 128-37-0 (2,6-di-tert-butyl-p-cresol), also has comparable values for the relevant molecular properties. Therefore, the results obtained with the substance CAS No. 118-82-1 can be used for the read-across approach.

Based on company data, the read-across approach is applied from 2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol and the substance 2,6 -di-tert-butyl-p-cresol (BHT) is considered to be non-irritant for the eyes.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The analogue CAS No. 118-82-1 (2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol) which shares the same functional group (alkylphenol) with the substance CAS no. 128-37-0 (2,6-di-tert-butyl-p-cresol), also has comparable values for the relevant molecular properties. Therefore, the results obtained with the substance CAS No. 118-82-1 can be used for the read-across approach.

Key study: Read-across from the analogue CAS No. 118-82-1: Skin irritation: In the 4 hour rabbit skin irritancy test, the test material caused no skin reactions and is therefore not a skin irritant.

Key study: Read-across from the analogueCAS No. 118-82-1 :Eye irritation: In the rabbit eye irritancy test, the test material caused slight conjunctival redness within 1 hour of dosing which had cleared by 24 hours. The test material is therefore not an eye irritant in rabbits.

Justification for classification or non-classification

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