Petroleum resins

Endpoint summary

Description of key information

Acute toxicity: oral - The LD50 of the test item Petroleum Resins (Kendex 0897) is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 April 2018 to 02 May 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Acute Oral Toxicity-Acute Toxic Class Method, OECD Guideline for Testing of Chemicals No 423, Adopted: 17th December 2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

No further details specified in the study report.

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Species: Wistar rats
Source: Dobrá Voda, Slovak Republic
Number and Sex of Animals: 6 females
Age at First Dose: 9-10 weeks; female animals were non-pregnant and nulliparous
Animal Health: Health condition of animals was examined by a veterinarian before initiation of the study.
Acclimation: The animals were acclimated under the conditions identical to the conditions during the experiment 5 days prior to the start of treatment. The acclimation was according to the standard operation procedure.
Housing Condition: The animals were housed in plastic cages suspended on stainless steel racks, 3 animals per cage in a room equipped with central airconditioning. The average room temperature was maintained within the range of 22.91 ± 0.55 °C, relative humidity within 54.62 ± 3.23 %. The light regimen was set to a 12-hour light /12-hour dark cycle. Sanitation was performed according to the standard operation procedures.
Diet: The laboratory food ssniff (Spezialdiäten GmbH, Germany) was offered at recommended doses each day approximately at the same time. The certificate of analysis is included in the raw data.
Water: The animals received tap water for human consumption. Supply of drinking was unlimited. The quality of drinking water is periodically analysed and recorded; certificate of analysis is included in the raw data.
Bedding: Lignocel S3/4, Lufa - ITL GmbH, Germany
Animals Identification: The animals in the cage were marked by a line (I-III) on the tail with a waterproof marker. Each cage was marked with the study code, ID of animals and date of administration of the test item.
Justification for the Choice of Species: Normally females are used for testing according to OECD TG 423 because females are typically the more sensitive gender.

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

Vehicle: Olive oil
Lot Number: L71143
Expiry Date: 10/2018
Manufacturer: Oleificio Luca, Italy
Storage: 20 ± 5 °C
Justification for the Choice of Vehicle: Olive oil is a common vehicle in toxicity studies like OECD TG 423

Dose Preparation: The required amount of the test item (according to the body weight and dose) was mixed with vehicle (Olive oil) shortly before administration. The dose of 2000 mg/kg was administered in a volume of 5 mL/kg body weight.

Dose Levels
The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. A limit dose of 2000 mg/kg body weight was used as a starting dose because available data indicated that the test item is probably non-toxic.

Doses:

2000 mg/kg/bw

No. of animals per sex per dose:

One group of 3 females was dosed. Test item-related mortality was not observed during 24 hours and therefore, in a second step, another 3 females were treated at the same dose.

Control animals:

no

Details on study design:

Clinical Observation
Animals were observed individually immediately after administration of the test item and 0.5, 1, 2, and 4 hours later. Each animal was inspected daily for the next 14 days.
Observations included: changes in skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity, and behaviour pattern. Particular attention was given to potential neurologic endpoints such as tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Body Weight
Individual weights of animals were measured immediately prior to administration of the test item and weekly thereafter. Weight differences after first and second weeks after administration were calculated and recorded.

Necropsy
All test animals were subjected to gross necropsy and the results were recorded for each animal.

Statistics:

Not specified.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All (6/6 females) animals survived the limit dose of 2000 mg/kg body weight.

Clinical signs:

other: No mortality was observed during the study. During the follow up period, no animals displayed signs of intoxication, change of health, nor any other adverse reaction.

Gross pathology:

All animals were necropsied. During necropsy, no macroscopic findings were observed.

Administration Results

Sex	Dose	ID	Result	Sex	Dose	ID	Result
Female	2000 mg/kg	1	Alive	Female	2000 mg/kg	4	Alive
		2	Alive			5	Alive
		3	Alive			6	Alive

 

Clinical Observation

Observation	Time After Administration
	Hour					Day
	Immediately	0.5	1	2	4	1	2	3	4	5	6	7	8	9	10	11	12	13	14
Skin and Hair	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Eyes	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Mucosa	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Respiratory System	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Circulatory System	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
CNS	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Somatomotoric Activity	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Tremor	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Spasms	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Salivation	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Diarrhea	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Lethargy	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Sleep	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Coma	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Death	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-

- No observed signs

 

Body Weight

Sex	Dose	ID	Body Weight (g)			Body Weight Difference (g)
			Initial	Week 1	Week 2	Week 1 – Initial	Week 2 – Initial	Week 2 – Week 1
Female	2000 mg/kg	1	199	28	22	19	30	11
		2	175	204	206	29	3	2
		3	18	206	206	38	38	0
		4	182	186	190	4	8	4
		5	189	93	204	4	15	11
		6	182	190	194	8	12	4

 

Necropsy Results

Sex	Dose	ID	Result	Sex	Dose	ID	Result
Female	2000 mg/kg	1	No finding	Female	2000 mg/kg	4	No finding
		2	No finding			5	No finding
		3	No finding			6	No finding

 

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The LD50 of the test item Petroleum Resins (Kendex 0897) is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item Petroleum Resins (Kendex 0897) is according to GHS criteria classified in Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats. According to UN Globally Harmonized System of Classification, Labelling and Packaging of Chemicals and Regulation (EU) Nr. 1272/2008 (CLP) the test item Petroleum Resins (Kendex 0897) is not classified.

Executive summary:

The purpose of the study was to evaluate the potential toxic effect of the test item Petroleum Resins (Kendex 0897) when administered as a single oral dose to Wistar rats.

The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used.

A limit dose of 2000 mg/kg body weight was used as a starting dose. The test item administered to 6 females at a limit dose did not cause death. The body weights of all animals increased during the study. A stagnation of body weight in one animal was observed between the first and the second week after administration of the test item. During necropsy, no macroscopic findings were observed.

The LD50 of the test item Petroleum Resins (Kendex 0897) is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.

Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item Petroleum Resins (Kendex 0897) is according to GHS criteria classified in Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats. According to UN Globally Harmonized System of Classification, Labelling and Packaging of Chemicals and Regulation (EU) Nr. 1272/2008 (CLP) the test item Petroleum Resins (Kendex 0897) is not classified.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

K1

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute toxicity: oral

The purpose of the study was to evaluate the potential toxic effect of the test item Petroleum Resins (Kendex 0897) when administered as a single oral dose to Wistar rats.

The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used.

A limit dose of 2000 mg/kg body weight was used as a starting dose. The test item administered to 6 females at a limit dose did not cause death. The body weights of all animals increased during the study. A stagnation of body weight in one animal was observed between the first and the second week after administration of the test item. During necropsy, no macroscopic findings were observed.

The LD50 of the test item Petroleum Resins (Kendex 0897) is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.

Justification for classification or non-classification

Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item Petroleum Resins (Kendex 0897) is according to GHS criteria classified in Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats. According to UN Globally Harmonized System of Classification, Labelling and Packaging of Chemicals and Regulation (EU) Nr. 1272/2008 (CLP) the test item Petroleum Resins (Kendex 0897) is not classified.