Ichthyolic acid, sodium salt

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November to December 1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

In the study report no reference to the above mentioned guideline is made.

Deviations:

not specified

Remarks:

LD50 was determined to be > 10000 mg/kg b.w. (males and females)

Principles of method if other than guideline:

The test substance was administered orally by gavage in graduated doses to three groups
of experimental animals (rats), one dose being used per group. Subsequently observations of effects were made as long as four weeks after administration of the test substance. Although the testing guideline is not mentioned in the study report, it is obvious that the principles of OECD guideline 401 were followed.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ichthyolic acid, sodium salt

EC Number:

215-671-7

EC Name:

Ichthyolic acid, sodium salt

Cas Number:

1340-06-3

IUPAC Name:

Identification of the UVCB substance by "Chemcial Abstracts Index Name", among others: Ichthyolic Acid, Sodium Salt. No IUPAC name known.

Test material form:

liquid

Specific details on test material used for the study:

The test substance named "ICHTHYOL Natrium hell" with batch number 4 - 5/72 in the study report originated from regular production by ÖSTERREICHISCHE ICHTHYOL (applicant/registrant). Its identity corresponds to the one of ICHTHYOL PALE. At the time of conduct of the study it has been in clinical use in dermatology for several decades.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Sprague-Dawley rats originated from breeder S.IVANOVAS, 7967 Kißlegg/Württ., Germany. Their weight was between 100 and 105 g and their age was 38 days for male animals and 42 days for female animals at the begin of the study. The animals were kept singly in Makrolon cages (type II) at room temperature (24.0 +- 0.5°C) and a relative humidity of 60% +- 3%.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Feeding was discontinued 15-16 hours before administration of the test substance which was diluted with distilled water and administered once by gavage at a volume of 20 ml/kg b.w. Water was available to the animals ad libitum.

Doses:

6,300/7,900/10,000 mg/kg b.w. (male and female)

No. of animals per sex per dose:

Five male and five female animals per dose.

Control animals:

no

Details on study design:

Mortality: no interval specified
Clinical signs: determined during the post-observation time of 4 weeks
General behaviour: determined during the post-observation time of 4 weeks
Body weights: determined during the post-observation time of 4 weeks
Food intake: determined during the post-observation time of 4 weeks
Necropsy: performed immediately after death of animals and at the end of the observation period on surviving animals

Statistics:

Study was without statistical evaluation due to the fact that no lasting effects could be observed and the LD50 could not be determined (LD50 > 10000 mg/kg b.w. (males and females). Higher dosages could not be applied because corresponding volumina were too large.

Results and discussion

Preliminary study:

No preliminary study indicated in available study report.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Remarks:

Volumina higher than 10000 mg/kg b.w. could not be applied.

Mortality:

No mortalities

Clinical signs:

Signs of slight sedation after administration of 7900 mg/kg b.w.; after 10000 mg/kg b.w. slight sedation and ataxia was observable. Total recovery within 24 hours, no lasting effects.

Body weight:

No changes in body weight development and food intake was observable.

Gross pathology:

On necropsy no specific pathological findings were evident (number and kind of organs not specified).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of Ichthyolic Acid, Sodium Salt (ICHTHYOL PALE) in rats was found to be above 10000 mg/kg b.w.

Executive summary:

The acute oral toxicity in rats was determined according to a method comparable to procedures described in OECD guideline 401 "Acute Oral Toxicity" (adopted 24 Feb 1987).

All animals survived the treatment and showed only slight signs of sedation after administration of 7900 mg/kg b.w. and slight sedation and ataxia after 10000 mg/kg b.w. All animals recovered within 24 hours. On necropsy no specific pathological findings were evident.

Under the experimental conditions described in this report, the oral LD50 of ICHTHYOL Natrium hell (identity corresponding to ICHTHYOL PALE as a synonym of Ichthyolic Acid, Sodium Salt) in rats was found to be above 10000 mg/kg b.w.