Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
30 mg/kg bw/day
Study duration:
chronic
Species:
rat
Quality of whole database:
Klimisch 2. Read-across approach.

The analogue CAS No. 128-37-0 (BHT) which shares the same functional group (alkylphenol) with the substance CAS no. 88-27-7 (2,6-di-tert-butyl-α-dimethylamino-p-cresol), also has comparable values for the relevant molecular properties. Therefore, the results obtained with the substance CAS No. 128 -37-0 can be used for the read-across approach.

Weight of evidence: Experimental results from two or three generation studies using different species and published in scientific articles.


Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information
Short description of key information:
Klimisch 2. Read-across approach.

The analogue CAS No. 128-37-0 (BHT) which shares the same functional group (alkylphenol) with the substance CAS no. 88-27-7 (2,6-di-tert-butyl-α-dimethylamino-p-cresol), also has comparable values for the relevant molecular properties. Therefore, the results obtained with the substance CAS No. 128 -37-0 can be used for the read-across approach.

Weight of evidence: Experimental results from two or three generation studies using different species and published in scientific articles.

Read-across approach: Based on the available information, the only effects on reproduction were lower numbers of litters of ten or more pups at birth . The NOAEL was 30 mg/kg bw/day in the rat.

Justification for selection of Effect on fertility via oral route:
The study with the longest duration and lowest NOAEL was chosen as key study (read-across approach).

Effects on developmental toxicity

Description of key information
Klimisch 2. Read-across approach. 
The analogue CAS No. 119-47-1 (6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol) 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. 119-47-1 can be used for the read-across approach.
Key study: Experimental results from developmental study in rats and read-across approach from an analogue.
Read-across approach: The NOAEL for maternal toxicity is 72 mg/kg bw/day and the NOAEL for developmental toxicity was 290 mg/kg bw/day (the highest dose tested).
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
290 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Klimisch 2. Read-across approach.

The analogue CAS No. 119-47-1 (6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol) 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. 119-47-1 can be used for the read-across approach.

Key study: Experimental results from developmental study in rats and read-across approach from an analogue.
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information
Justification for selection of Effect on developmental toxicity: via oral route:
Only one study available (read-across approach)

Justification for classification or non-classification

Based on the available data, the substance is not classified for toxicity to reproduction.