1,4-dibromonaphthalene

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:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

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:

1,4-dibromonaphthalene

EC Number:

201-484-8

EC Name:

1,4-dibromonaphthalene

Cas Number:

83-53-4

Molecular formula:

C10H6Br2

IUPAC Name:

1,4-dibromonaphthalene

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Six Sprague Dawley rats (SPF Caw) were used after an acclimatization period of at least five days. The animals were nulliparous and non-pregnant. At the beginning of the study, the animals were 8-week old.
They were identified prior to inclusion in the test by means of a numbered ring on the edge of one ear. As no information regarding the toxicological properties by oral route of the test item was provided,
the starting dose was 2000 mg/kg.

Housing:
Healthy female rats were housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry. The temperature and relative humidity during the main test were controlled to remain within target ranges of 19°C to 25°C and 30% to 70%, respectively. The rate of air exchange was at least ten changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.

Food and drink:
Drinking water (tap-water from public distribution system) and foodstuff were supplied ad libitum. Food was removed on day 1 and then redistributed 4 hours after the test item administration.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

DMSO

Details on oral exposure:

In the first and second step of the study, 2.0026 g and 2.0000 g of the test item were weighed and DMSO (Dimethyl sulfoxide) was added to two 10 mL volumetric flasks. Just before the administration, the preparations were stirred by ultraturrax during 1 minute at 20000 rpm and by vortex to obtain white homogeneous suspensions.
Each preparation was administered under a volume of 10 mL/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.

Doses:

2000 mg/kg bw/d

No. of animals per sex per dose:

6 female rats were administered 2000 mg test item/kg bw/d.

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study.

Clinical signs:

No clinical signs related to the administration of the test item were observed during the study.

Body weight:

The body weight evolution of the animals remained normal during the study.

Gross pathology:

The macroscopic examination of the animals at the end of the study revealed a thinning of forestomach (2/6). No other changes were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item 1,4-DIBROMONAPHTHALENE is higher than 2000 mg/kg body weight. In accordance with the O.E.C.D. Test Guideline No. 423, the LD50 cut-off of the test item may be considered as 5000 mg/kg body weight by oral route in the rat.
The test item 1,4-DIBROMONAPHTHALENE does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures. No signal word or hazard statement is required.