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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
no guideline followed; limited details on materials and methods and results provided

Data source

Reference
Reference Type:
publication
Title:
Toxicologic Studies with 2,6-Di-tert-Butyl-4-Hydroxymethylphenol in the Rat
Author:
Dacre, J.C.
Year:
1970
Bibliographic source:
Toxicol Appl Pharmacol 17: 669-678

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Groups of 5 rats were exposed to up to 7000 mg/kg bw test substance by gavage. Animals were fasted overnight and observed for 14 days to determine a LD50 value.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3,5-di-tert-butyl-4-hydroxybenzyl alcohol
EC Number:
201-815-6
EC Name:
3,5-di-tert-butyl-4-hydroxybenzyl alcohol
Cas Number:
88-26-6
Molecular formula:
C15H24O2
IUPAC Name:
2,6-Di-tert-butyl-4-(hydroxymethyl)phenol

Test animals

Species:
rat
Strain:
other: random-bred albino rat
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Otago University, Otago, New Zealand
- Weight at study initiation: 150-250 g
- Fasting period before study: fasted overnight
- Housing: 5 animals per cage
- Diet: wholemeal (25%), meatmeal (20%), pollard (18.5%), milk powder (15%), maize meal (10%), bran (10%), cod liver oil (0,8%), salt (0,6%), ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: mixture of acetone and dimethylsulfoxide (1:2 (v/v))
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
Doses:
2.5, 4.0, 5.0 and 7.0 g/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

Results and discussion

Preliminary study:
no sighting study performed
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 000 mg/kg bw
Based on:
test mat.
Mortality:
1 male rat died 7 days after dosing, but no specific cause of death was determined in autopsy.
Clinical signs:
No clinical signs were observed in any animal throughout the 14-day post-treatment period.
Body weight:
No information provided.
Gross pathology:
Autopsy of the deceased male rat did not reveal the cause of death (no further information provided).

Applicant's summary and conclusion

Interpretation of results:
other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified