3',5'-dichloro-4'-ethyl-2'-hydroxypalmitanilide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1989, may 19th to 1989, june 7th

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study performed according to the Test Guidelines described in the EEC Directive 84/449/EEC

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

3',5'-dichloro-4'-ethyl-2'-hydroxypalmitanilide

EC Number:

406-200-8

EC Name:

3',5'-dichloro-4'-ethyl-2'-hydroxypalmitanilide

Cas Number:

117827-06-2

Molecular formula:

C24H39Cl2NO2

IUPAC Name:

N-(3,5-dichloro-4-ethyl-2-hydroxyphenyl)hexadecanamide

Details on test material:

UC-136
White powder
Purity 98.5%
Storage conditions: at room temperature in the dark in a tighly sealed container
Stability of test substance: stable for one year maximal under storage conditions
Safety precautions: gloves and goggles were used to assure personnel health and safety

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test system Albino rats, Wistar (outbred, SPF—Quality)
Rationale Recognised by international guidelines as the recommended test system (e.g. EPA, OECD, EEC).
Source Charles River Wiga, Sulzfeld, West—Germany
Number of animals 5 males, 5 females
Age at start of treatment Approx. 7 weeks
Body weight at start males: 193 — 225g
of treatruent females: 169 — 175g
Identification Earmark
Randomisation Randomly selected at the time of delivery in groups of five.
Acclimatisation At least 5 days under laboratory conditions.
Husbandry
Room Number: 5
Standard Laboratory Conditions.
Air—conditioned with 7.5—15 air changes per hour, and hourly monitored environnent with the temperature set at 21 ± 3°C, the relative humidity 30—70% (actual range: 60—80%) and 12 hours artificial fluorescent light / 12 hours dark per day.
Accommodation
Housed in groups of five per sex in polycarbonate cages containing purified sawdust as bedding material (Woody Clean supplied by Broekman Institute,Someren, The Netherlands).
Diet
Free access to standard pelleted laboratory animal diet (RMH—B from Hope Farms, Woerden, The Netherlands). Certificates of analysis were examined and are retained in the RCC NOTOX archives.
Water
Free access to tap—water. Certificates of analysis were examined and are retained in the RCC NOTOX archives.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

Vehicle 1% aqueous methyl cellulose.
Stability of test substance in vehicle Stable for at least 4 hours.
TEST SUBSTANCE PREPARATION
The formulations were prepared immediately prior to dosing. The test substance was weighed into a glass flask on an analytical balance and the vehicle (w/w) was added.
Homogeneity of the test substance in vehicle was obtained by a homogeniser.
Treatment
Method: Oral gavage
Fasting Feed was withheld overnight prior to dosing until approximately 3—4 hours after administration of the test substance.
Frequency Once, on day 1.

Doses:

Dose level: 5000 mg/kg body weight.
Dose volume: 10 ml/kg body weight.

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Details on study design:

Mortality / Viability At periodic intervals on the day of dosing (day 1) and twice daily thereafter for at least 14 days.
Body Weights Test days 1 (pre—administration), 8 and 15.
Symptoms At periodic intervals on the day of dosing(day 1) and once daily thereafter. All signs of reaction to treatment were recorded with particular attention paid to changes in the skin, fur, eyes and mucous membranes, as well as to behaviour pattern, tremors, convulsion, salivations, diarrhoea, lethargy, sleep and coma.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

UC—136 was administered to rats of both sexes by oral gavage at 5000 mg/kg body weight.
No mortality occurred during the study period.

Clinical signs:

other: There were no clinical signs of toxicity or behavioural changes over the 15 day observation period that were considered to be a result of treatment.

Gross pathology:

Macroscopic examination of all animals at termination did not reveal any changes that were considered to have arisen as a result of treatment.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 value of UC—136 in rats of’ both sexes was estimated to exceed 5000 mg/kg body weight.
According to the general classification and labelling requirements for dangerous substances (EEC Directive 83/467/EEC, Annex VI of the EEC Directive 671548/EEC), UC—136 can not be classified and therefore should be considered as non—harmful.