resorcinol; 1,3-benzenediol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline Study; Not GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1962

Materials and methods

Test guideline

Guideline:

other:

Principles of method if other than guideline:

Method: Federal Register of August 12 1961, pages 7333-7341.

The study was conducted in accordance with Federal Hazardous Substances Labeling Act (FHSLA), Federal Register Aug. 12, 1961, p 7333-7341, Part 191 "Hazardous Substances Definitions and Procedural and Interpretative Regulations, Final Order"

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Resorcinol

EC Number:

203-585-2

EC Name:

Resorcinol

Cas Number:

108-46-3

Molecular formula:

C6H6O2

IUPAC Name:

resorcinol

Details on test material:

Industrial Grade Resorcinol

Test animals

Species:

rabbit

Strain:

not specified

Sex:

male

Administration / exposure

Vehicle:

physiological saline

Doses:

1000, 2000, 3980 and 7950 mg/kg

No. of animals per sex per dose:

4/dose group, males

Control animals:

not specified

Details on study design:

Four groups of male albino rabbits were used (4/dose group), weighing between 2.3-3.0 kg after undergoing a seven day laboratory observation and acclimatization period.

The rabbits were administered the following doses of industrial resorcinol: 1000, 2000, 3980 and 7950 mg/kg. Prior to exposure, the animals were prepared by clipping the skin of the trunk, approximately 10% of the body surface, free of hair. One-half of each group was further prepared by making epidermal abrasions every two or three centimeters longitudinally over the area of future exposure. The abrasions were sufficiently deep to penetrate the stratum corneum but not to disturb the derma and cause bleeding. The skin and the material, which was evenly distributed on cotton gauze in an amount calculated to yield the desired dosage level, were moistened with physiological saline. The gauze and material were applied to the skin of the rabbits and the entire trunk was wrapped in an impervious plastic film. The maximum justifiable dosage level for solids in this procedure is approximately 4. 0 gm. /kg. which is twice the upper limit for the "toxic substance" category as defined in the regulations pursuant to the FHSLA. Following dosing, the rabbits were immobilized in stocks for 24 hours after which the dam and any excess chemical were removed and the skin was examined for gross changes. Mortality due to the effect of the chemical was considered complete after 14 days. All fatalities were subjected to autopsies to exclude extraneous causes of death while some survivors were sacrificed and examined for the existence of gross lesions.

Statistics:

The skin penetration LD50, based upon mortality attributable to the material during the 14-day observation period, was estimated employing Thompson's method of moving averages using the tables of Weil.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

2 830 mg/kg bw

Gross pathology:

No internal gross lesions were observed at necropsy.

Other findings:

The material produced necrosis of the skin in all the rabbits exposed to 3980 mg/kg and above for the Flaked Grade and to 2000 mg/kg and above for the Industrial Grade. The rabbits exposed to 1000 mg/kg Flaked Grade showed only slight hyperkeratosis following signs of moderate to severe irritation after 24 hours contact. However the same dose of the Industrial Grade showed no signs of irritation seven days following contact.

Any other information on results incl. tables

RS-Freetext:

Industrial Grade:
Dosage mg/kg                No. Died/No. Dosed        Days after dosing on which death occurred
1000                         0/4                        -
2000                         0/4                         -
3980                         4/4                         1 (4)
7950                         4/4                         1 (4)

95% confidence limits: cannot be calculated due to the all or none response.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 is 2830 mg/kg bw . The results were evaluated in association with the EC 1272/2008 (CLP). The substance does not fall within any categories identified.