Benzoic acid, 4-hydroxy-, docosyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline andGLP-Study with no deviations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

docosyl 4-hydroxybenzoate

EC Number:

920-338-0

Cas Number:

109236-76-2

Molecular formula:

C29 H50 O3

IUPAC Name:

docosyl 4-hydroxybenzoate

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Species: Healthy rats (Full-Barrier)
Strain: HsdRccHan: WIST
Source: Harlan Winkelmann GmbH, D-33178 Borchen.
Sex: female, non-pregnant, nulliparous
Age at the beginning of the study: 8-12 weeks old
Number of animals: 3 per step
Body weight at the beginning of the study: Animals no 1 - 3, step 1: 174 - 196 g; Animals no 4-6, step 2: 190- 191 g;
The animals were derived from a controlled full barrier maintained specific pathogen free breeding system. According to Art. 9.2, No.7 of the German Act on Animal Welfare the animals were bred for experimental purposes.

Housing and feeding conditions
Semi-barrier in an air conditioned room
- Temperature: 22 ± 3 °C
- Relative humidity: 55 ± 10%
- Artificial light, sequence being 12 hours light, 12 hours dark Air change: 10 x / hour
Free access to Altromin 1324 maintenance diet for rats and mice
Free access to tap water, sulphur acidified to a pH value of approx. 2.8 (drinking water, municipal residue control, microbiologically controlled
at frequent intervals)
- The animals were kept in IVC cages, type III H, polysulfone cages on Altromin saw fiber bedding
Certificates of food, water and bedding are filed at BSL Bioservice
Adequate acclimatization period (at least 5 days)

The animals were marked for individual identification by tail painting. Prior to the administration a detailed clinical observation was made of all
animals. Only healthy animals were used for the test. Prior to the administration the food was withheld from the test animals overnight. Following
the period of fasting the animals were weighed and the test item was administered. Then the food was withheld for a further 3-4 hours.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

cotton seed oil

Doses:

2000 mg/kg

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

Administration:
The test item was administered in a single dose by gavage using an intubation cannula. The test item was administered at a volume of 10 mL/kg body weight.

Dose level:
The starting dose was selected to be 2000 mg/kg body weight. No compound related mortality was recorded for any animal of step 1 or of step 2. Based on these results and according to the acute toxic class method regime no further testing was required.

Observation period:
The animals were observed for 14 days after dosing.

Weight assessment:
The animals were weighed prior to the administration and once a week thereafter.

Clinical examination:
A careful clinical examination was made several times on the day of dosing (at least three observations within the first four hours post-dose). The animals were observed once a day thereafter.

Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nei'vous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Pathology:
At the end of the observation period the animals were sacrificed by an overdosage of pentobarbital injected intraperitoneally. All animals were subjected to gross necropsy. All gross pathological changes were recorded.

Evaluation of results:

Results were interpreted according to OECD Guideline 423, Annex 2 (see also flow charts in the Annex of the project protocol). Individual reactions of each animal were recorded at each observation time. Toxic response data were recorded by sex and dose level. Nature, severity and duration of clinical observations were described. Body weight changes were summarised in tabular form. Necropsy findings were described.

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

The test item showed no acute oral toxic characteristics.

Clinical signs:

other: The test item showed no acute oral toxic characteristics.

Gross pathology:

With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no special gross pathological changes were recorded for any animal of the two steps.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the present study it can be stated that the test item 4-Hydroxybenzoic acid behenylester showed no acute oral toxic
characteristics. The oral LD50 cut-off was determined to be 5000 mg test item/kg body weight. According to GHS (Globally Harmonized Classification System) the test item 4-Hydroxybenzoic acid behenylester was not classified.