Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The experiment was performed between 28 February and 16 March 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
The experimental protocol was established according to the official method as defined in the O.E.C.D. Test Guideline No. 423 dated December 17th, 2001 and the test method B.1tris of the Council Regulation No. 440/2008.
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Certificate attached in the study report
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
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 of 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.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: graduated syringe fitted with an oesophageal metal canula
Details on oral exposure:
The test item was administered by gavage under a volume of 1.89 mL/kg body weight (corresponding to 2 g/kg, according to the calculated density) using a suitable graduated syringe fitted with an oesophageal metal canula.
Doses:
The animals of the treated group received an effective dose of 2000 mg/kg body weight of the test item Pine tar / Tar,Pinus sylvestris.
No. of animals per sex per dose:
6
Control animals:
yes
Details on study design:
Systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions during 14 days following the administration of the test item. This examination focuses particularly on a list of symptoms, recorded as "present" or "absent" on the
observation sheet. These observations were compared to historical control data. Observations and a mortality report were then carried out every day for 14 days.
Statistics:
The clinical observations are given in the observation data sheets.
The details of body weight evolution are presented in Table 4 in attached study report.
The results of the macroscopic examinations are given in the necropsy data sheets (Tables 5 & 6).

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred during the study.
Clinical signs:
It was only noted an increase of salivation and mydriasis at 30 minutes post-dose in only one animal (1/6). No other signs of systemic toxicity were noted.
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 thickening of white forestomach (3/6).

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The LD50 of the test item Pine tar / Tar,Pinus sylvestris is higher than 2000 mg/ kg body weight by oral route in the rat. In accordance with the O.E.C.D. Test Guideline No. 423, the LD50 cut-off of the test item may be considered to be higher than 5000 mg/ kg body weight by oral route in the rat.
The test item Pine tar / Tar,Pinus sylvestris 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.
Executive summary:

The test item Pine tar / Tar,Pinus sylvestris was administered, as supplied, to a group of 6 females Sprague Dawley at the dose of 2000 mg/ kg body weight. The experimental protocol was established according to the official method as defined in the O.E.C.D. Test Guideline No. 423 dated December 17th, 2001 and the test method B.1tris of the Council Regulation No. 440/2008. No mortality occurred during the study.

In conclusion, the LD50 of the test item Pine tar / Tar,Pinus sylvestris is higher than 2000 mg/ kg body weight by oral route in the rat.

In accordance with the O.E.C.D. Test Guideline No. 423, the LD50 cut-off of the test item may be considered to be higher than 5000 mg/ kg body weight by oral route in the rat.

The test item Pine tar / Tar,Pinus sylvestris 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.