Formaldehyde, telomer with 1,3-benzenedimethanamine, 1,3-benzenediol and ethenylbenzene

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

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:

Formaldehyde, telomer with 1,3-benzenedimethanamine, 1,3-benzenediol and ethenylbenzene

EC Number:

615-240-7

Cas Number:

710292-85-6

Molecular formula:

Not available for this UVCB

IUPAC Name:

Formaldehyde, telomer with 1,3-benzenedimethanamine, 1,3-benzenediol and ethenylbenzene

Test material form:

other: waxy solid

Details on test material:

commercial sample. no data on purity

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH
Sandhofer Weg 7
D-97633 Sulzfeld

- Age at study initiation: 34 d
- Weight at study initiation: 172 - 200 g
- Fasting period before study: yes
- Housing: Granulated textured wood (Granulate A2, J Brandenburg, D-49424 Goldenstedt) was used as bedding material for the cages The cages were changed and cleaned twice a week. Periodic analysis of the bedding material for contaminants based on EPA/USA is conducted at least once a year by LUFA-ITL. During the 14-day observation period the animals are kept singly in MAKROLON cages (type Ill) at a room temperature of 22° C ± 3 ° C (maximum range) and a relative humidity of 60% ± 20% (maximum range). The rooms were lit (150 lux at approx 1 50 m room height) and darkened for periods of 12 hours each.
- Diet (e.g. ad libitum): Altromin 1324 (ALTROMIN GmbH, D-32791 Lage/Lippe, composition see Appendix 1) served as food. Feeding was discontinued approx 16 hours before administration, only tap water was then available ad libitum.
Periodic analysis of the food for contaminants based on EPA/USA1 is conducted at least twice a year by LUFA-11-L2 (limitation for contaminants in the diet see Appendix 2).
- Water (e.g. ad libitum):Drinking w ater in bottles was offered ad libitum. Drinking water is examined according to the 'Deutsche Trinkwasserverordnung, Bun¬desgesetzblatt, Jahrgang 1990' by the Hamburger Wasserwerke, D-20539 Hamburg, at least four times a year (limitation for contaminants in the drinking water see Appendix 1).
- Acclimation period: 5 days



IN-LIFE DATES: From: October 7th, 1999 to October 21st, 1999

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

A dose level of 2000 mg/kg bw, at 10 ml per kg bw, was tested in 5 males and 5 females (Limit-test).

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Following administration, observations were made and recorded systematically with individual records being maintained for each animal. Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after ad¬ministration. All surviving animals were observed. Observations on mortality were made at least once daily with appropriate actions taken to minimize loss of animals during the study. Individual body weights were recorded before administration of the substance and thereafter in weekly intervals up to the end of the study, and at death. Changes in weight were calculated when survival exceeds one day
At the end of the experiments all surviving animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded. From ani¬mals which survive 24 hours or longer a microscopic examination of all organs which showed evident lesions was performed, if necessary. Autopsy and macroscopic in¬spection of animals which died prematurely were carried out as soon as possible after exitus.

Statistics:

no data

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality

Mortality:

No mortality

Clinical signs:

other: no clinical signs

Gross pathology:

No pathology, no microscopic examinations

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance, when administered by gavage in oil to Sprague-Dawley rats (male and female) in a limit test of 2000 mg/kg bw, resulted in no deaths. The LD50 is over 2000 mg/kg bw.