Rectified Hydrocarbons by-products from synthetic process of Turpentine and acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09 May 2018 - 29 May 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (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:

Rectified Hydrocarbons by-products from synthetic process of Turpentine and acid

EC Number:

947-956-3

Molecular formula:

Not available since an UVBC substance.

IUPAC Name:

Rectified Hydrocarbons by-products from synthetic process of Turpentine and acid

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

(SPF Caw)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage JANVIER LABS (53940 Le Genest St Isle – France)
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 or 9 weeks
- Weight at study initiation: 212.3 g (SD = 17.4 g)
- Fasting period before study: Food was removed on D-1 and then redistributed 4 hours after the test item administration.
- Housing: 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.
- Diet (e.g. ad libitum): Ad libitum. Teklad Global 16% Protein Rodent Diet (ENVIGO 2016).
- Water (e.g. ad libitum): Ad libitum. Drinking water (tap-water from public distribution system). Microbiological and chemical analyses of the water were carried out once every six months by Bureau Veritas – Eurofins (FRANCE).
- Acclimation period: the animals were acclimatized for at least 5 days before treatment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19ºC to 25ºC
- Humidity (%): 30 to 70%
- Air changes (per hr): >10 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light (07.00 to 19.00) and 12 hours dark cycle.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.09 mL/kg body weight (corresponding to 2 g/kg, according to the calculated density)

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Available information suggests that mortality is unlikely at the highest starting dose level (2000 mg/kg body weight). Hence, the study is initiated with the starting dose of 2000 mg/kg body weight.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 (3 female rats per step)

Control animals:

yes

Remarks:

(study performed on three animals receiving distilled water under requirements of OECD Guideline 423)

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At each step, the animals were observed four times on test day 0 (day of administration), i.e. at T0+30 min, T0+1h, T0+3h and T0+4h, and once daily during days 1 to 14 post administration. The body weights were recorded on test day 0 (just before administration) then on D2, D7, and D14.
- Necropsy of survivors performed: yes. At termination, gross pathological findings were recorded and reported.
- Other examinations performed:
Clinical observations included: spontaneous activity, Preyer’s reflex (noise), respiratory rate, convulsions, tremors, body temperature, muscle tone, palpebral opening, pupil appearance, salivation, lachrymation, righting reflex, back hair appearance.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study.

Clinical signs:

other: A decrease of spontaneous activity (2/6) was noted at 30 minutes post-dose. The animals recovered a normal activity at 1 hour post-dose. No other clinical signs were observed.

Gross pathology:

The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.

Any other information on results incl. tables

Table 1: Body weight and weight gain in grams

Females	D0	D2	D2-D0	D7	D7-D0	D14	D14-D0
Rf 2500	193	220	27	250	57	263	70
Rf 2501	196	210	14	235	39	248	52
Rf 2502	204	201	-3	241	37	267	63
Rf 2544	232	232	0	265	33	285	53
Rf 2545	232	230	-2	278	46	296	64
Rf 2546	217	226	9	260	43	280	63
MEAN	212.3	219.8	7.5	254.8	42.5	273.2	60.8
SD	17.4	12.2	11.7	16.0	8.4	17.2	7.0

Applicant's summary and conclusion

Interpretation of results:

other: Not classified (CLP Regulation EC no. 1272/2008)

Conclusions:

The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat. The LD50 cut-off may be considered to be 5000 mg/kg body weight by oral route in the rat.

Executive summary:

The acute oral toxicity of the test item has been tested in accordance with OECD Test Guideline 423, following GLP. 6 female Sprague-Dawley rats divided in 2 groups were administered sequentially with test item by oral gavage. The first set of 3 female rats was given a single dose of 2000 mg/kg body weight. No mortality was observed at this dose level, so the second set of 3 female rats was treated at the same dose level. No mortality was observed at this dose level either. The body weight evolution of the animals remained normal during the study. A decrease of spontaneous activity (2/6) was noted at 30 minutes post-dose. The animals recovered a normal activity at 1 hour post-dose. No other clinical signs were observed. The macroscopic examination of the animals at the end of the study did not reveal treatment related effects. The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat. As per OECD Test Guideline 423, the LD50 cut-off of the test item may be considered to be 5000 mg/kg body weight by oral route in the rat.