2-cyclododecylpropan-1-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-09-19 to 1990-11-12

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test according to OECD guideline 401 and according to the OECD-GLP regulations, fixed in the Chemikaliengesetz 1990, but lack of data on the purity / quality of the sample tested.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

HYDROXYAMBRAN

IUPAC Name:

HYDROXYAMBRAN

Test material form:

solid: crystalline

Details on test material:

Hydroxyambran

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals:
Species: rat
Strain: Crl.: (WI)BR – Wistar, white
Source: Firma Charles River wiga, Sandhofer Weg 7, 8714 Sulzfeld
Date of receipt August 29, September 19 and October 04, 1990
Acclimation period: at least 7 days
Animal selection: random
Animal identification: with colored markings; cage labelled with dosage, sex, date of study initiation, project no.
Weight range at
study initiation: m: 216 – 247 g; f: 196 – 227 g

Husbandry:
Housing: collective housing up to a maximum of 5 animals per cage (Macrolon type III)
Illumination: artificial lighting (120 lux) from 7.00 a.m. – 7.00 p.m.
Temperature: 21 +/- 2 °C
Relative humidity: 50 – 85 %
Measurement: with thermohygrometer twice daily
Diet: Administration: ad libitum*
Manufacturer: Ssniff Spezialdiäten GmbH, 4770 Soest Westfahlen
Name: Ssniff-R, Alleindiät
Form: Pellets
Water: Administration: ad libitum
System: drinking bottles
Quality: Drinking water as for human consumption
Quality control: half-yearly analyses and bacteriological tests

*The animals were fasted from 16 h before until 3-4 h after administration of the test article.

Prior to study initiation, the animals were acclimated to laboratory conditions for at least 7 days. Only healthy animals were used in the test.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

vegetable oil

Details on oral exposure:

The test article was administered as a dilution of 50 % in vegetable oil. The pH value was 5.5.
A single oral administration of the test article was perfomed by gavage using a stomach tube.

Doses:

10 000 mg/kg body weight

No. of animals per sex per dose:

Range finding (preliminary study): 2 female animals
Main test: 5 male and 5 female animals

Control animals:

no

Results and discussion

Preliminary study:

There were no deaths in the preliminary study with 10 000 mg/kg bw.

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

No animal died during the course of main study.

Clinical signs:

Abnormal clinical signs such as reduced activity, abnormal gait, abdominal position, reduced grip strength and limb tone and piloerection were observed within 1h - 48h p.a.

Body weight:

Weight gains were normal in all animals.

Gross pathology:

Gross pathological examinations at 14 days p.a. (terminal necropsy) revealed no test article-dependent findings.

Any other information on results incl. tables

Body weights:

Individual Values:

Animal No.	Sex	Day 0	Day 7	Day 14
1	m	247	290	330
2	m	242	303	363
3	m	200	276	314
4	m	216	282	330
5	m	242	303	368
6	w	227	274	285
7	w	206	253	273
8	w	223	245	268
9	w	196	232	260
10	w	203	234	262

 

Mean Values:

Sex	n	Day 0	Day 7	Day 14
males	5	229	291	341
females	5	211	248	270
m + f	10	220	269	305

 

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 value for male and female animals is greather than 10 000 mg/kg bw.

Executive summary:

The acute oral toxicity of Hydroxyambran was determined according to the OECD Test Guideline 401 in a limit test with 10 000 mg/kg bw in rats.

No animals died during the course of the study.

Abnormal clinical signs were observed only within 1h - 48h p.a.

Weight gains were normal in all animals.

Gross pathological examinations at 14 days p.a. (terminal necropsy) revealed no test article-dependent findings.

The LD50 value for male and female animals is greather than 10 000 mg/kg bw.