4-chlororesorcinol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August/September, 1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Guideline:

other: not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-chlororesorcinol

EC Number:

202-462-0

EC Name:

4-chlororesorcinol

Cas Number:

95-88-5

Molecular formula:

C6H5ClO2

IUPAC Name:

4-chlorobenzene-1,3-diol

Test material form:

other:

Remarks:

beige powder

Details on test material:

Molecular weight: 144.65

Test animals

Species:

rat

Strain:

other: CFY

Sex:

male/female

Details on test animals or test system and environmental conditions:

Rats, in the weight range 95 to 122g were starved overnight before treatment with 4-chlororeaorcinol.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous sodium sulphite (0. 05%) solution

Details on oral exposure:

4·Chlororesorcinol was prepared as a 10% solution in aqueous sodium sulphite (0. 05%) and administered by oral intubation at a range of dosage volumes in the full scale test of 1.6 to 6.4 ml/kg bodyweight.

Doses:

160, 250, 400, 640 mg/kg

No. of animals per sex per dose:

4

Control animals:

yes

Details on study design:

Rats of the CFY strain, in the weight range 95 to 122g were starved overnight before treatment with 4-chlororeaorcinol.
4·Chlororesorcinol was prepared as a I0% solution in aqueous sodium sulphite (0. 05%) and administered by oral intubation at a range of dosage volumes in the full scale test of 1.6 to 6.4 ml/kg bodyweight. Rats treated with the vehicle alone (6. 4 ml/kg) served as controls.

During the observation period of 14 days, a record was kept of all mortalities and signs of toxicity. All rats that died were examined macroscopically in an attempt to identify the target organs, and those animals surviving terminally were similarly examined to detect possible residual damage.

From the mortality data the LD50 and its 95%o confidence limits were calculated by the method of Weil C. S. (1952), Biometrics, 8, 249.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

369 mg/kg bw

Mortality:

Death occurred from within one to two hours of treatment.

Clinical signs:

other: Signs of reaction to treatment, observed shortly after dosing, included lethargy, piloerection and decreased respiratory rate. These signs were accompanied by fine body tremors in rats treated at 160, 250 and 400 mg/kg, by ataxia in female rats at 160 and

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The acute median lethal oral dose (LD50) and its 95% confidence limits to rats of 4-chlororesorcinol were calculated to be:
369 (314 to 433) mg/kg bodyweight.

Executive summary:

The results of preliminary range finding tests indicated that the median lethal oral dose (LD50 ), was in the region of 250 to 640 mg/kg bodyweight. Dosing was then extended to larger groups of rats (five males and five females) in order to locate the median lethal dose more precisely. Signs of reaction to treatment, observed shortly after dosing, included lethargy, piloerection and decreased respiratory rate. These signs were accompanied by fine body tremors in rats treated at 160, 250 and 400 mg/kg, by ataxia in female rats at 160 and 400 mg/kg and all rats at 640 mg/kg and by loss of righting reflex and coarse body tremore: in rats at 640 mg/kg. Death occurred from within one to two hours of treatment. Autopsy revealed slight haemorrhage of the lungs, darkening of the liver, kidneys and spleen, and injection of mesenteric blood vessels. Recovery of survivors, as judged by external appearance and behaviour, was apparently complete within two days of treatment. This observation was substantiated by normal bodyweight gains compared with controls and normal autopsy findings.