1,3-Benzenediol, 4-butyl-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1935

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study is reported in a scientific journal publication which investigates the toxicty of a number of 4-n-alkylresorcinols, including 4-n-hexylresorcinol. Information on 4-n-hexylresorcinol is available from a WHO review, which cites and supports the findings from this scientic journal publication with regards to 4-n-hexylresorcinol. Therefore the study is considered as reliable with restrictions.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1935

Report date:

1935

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

not specified

Principles of method if other than guideline:

No information on the method is available other than on the route of administration and the dose.

GLP compliance:

no

Test type:

other: two dose acute toxicity study

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-n-butylresorcinol

IUPAC Name:

4-n-butylresorcinol

Details on test material:

No information on the test material is available

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

no information

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: ethylene glycol

Details on oral exposure:

None specified

Doses:

Doses were approx. 500 mg/kg bw and 1000 mg/kg bw

No. of animals per sex per dose:

No information

Control animals:

not specified

Details on study design:

no information

Statistics:

no information

Results and discussion

Preliminary study:

There is no information on a preliminary study

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

ca. 500 mg/kg bw

Based on:

test mat.

95% CL:

ca. 0

Remarks on result:

other: confidence level cannot be established therefore expressed as circa 0

Mortality:

Approx. 50% of the animals died at the lowest test level (circa 500 mg/kg bw). Approx. 80% of animals died at the highest dose level (circa 1000 mg/kg bw).

Applicant's summary and conclusion

Interpretation of results:

other: harmful if swallowed

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

LD50 (rat) = 500 mg/kg bw
In accordance with Directive 67/548 the substance should be classified as R22: Harmful if swallowed

Executive summary:

A study is available for 4-n-butylresorcinol, as reported in a scientific journal publication. As the information in the study is limited, the robustness was assessed by considering LD50 values reported in the same study for 4-n-hexylresorcinol. A review of the acute toxicity of 4-n-hexylresorcinol is available in the WHO Food Additives Series 35, which supports the findings of the scientific journal publication. A LD50 of 500 mg/kg bw in rats therefore appears appropriate for 4-n-butylresorcinol. In accordance with Directive 67/548 the substance should be classified as R22: Harmful if swallowed.