Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals 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.