Rosin, decarboxylated

Endpoint summary

Description of key information

The potential for acute oral toxicity of the test material AA-948 -61 (Decarboxylated Rosin, CAS No. 8050 -18 -8) was determined according to the OECD 423 Testing Guideline.

A group of three fasted female rats received a single oral gavage dose of the test item, formulated in corn oil, at a dose level of 2000 mg/kg body weight. As results at this dose level indicated the acute lethal oral dose of the test item to be greater than 2000 mg/kg body weight, in compliance with the study guidelines, a further group of three fasted females was similarly dosed at 2000 mg/kg body weight to complete the study. During the study, clinical condition, body weight and macropathology investigations were undertaken.

Under the conditions of the study, the acute median lethal oral dose (LD50) to rats of AA-948- 61 (Decarboxylated Rosin, CAS No. 8050-18-8) was demonstrated to be greater than 2000 mg/kg body weight. AA-948-61 (Decarboxylated Rosin, CAS No. 8050-18-8) is included in Category 5/Unclassified, according to the Globally Harmonised System (GHS).

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:

2020-10-27 to 2020-12-16

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)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Animal information
Healthy nulliparous and non-pregnant female RccHan®:WIST albino rats were obtained from
- Source: Envigo RMS (UK) Ltd.
- housing: Group housed by three rats of the same sex. Solid bottomed polycarbonate cages with a stainless steel mesh lid.
- acclimatisation: at least five days
- body weights: 163 to 179 g, the body weight variation did not exceed ± 20% of the mean weight of any previously treated animals.
- age of animals: approximately eight to twelve weeks of age prior to dosing (Day 1).
Each cage of animals was provided with Aspen chew blocks or balls for environmental enrichment. Chew blocks or balls were provided throughout the study and were replaced when necessary. Each cage of animals was provided with a plastic shelter for environmental enrichment, which was replaced at the same time as the cages.
Diet: standard rodent pelleted diet (Teklad 2014C Diet) ad libitum (except for overnight prior to and approximately four hours after dosing)
Water:Potable water taken from the public supply ad libitum
Environmental conditions

-Temperature range:20 to 24°C
-Relative humidity range: 40 to 70%
-artificial lighting: a cycle of 12 hours continuous light and 12 hours continuous dark per 24 hours.
- air changes: not reported

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

The appropriate dose volume of the test item was administered to each rat by oral gavage using a plastic syringe and plastic catheter. A record of the weight of each formulation dispensed and the amount remaining after dosing was made. The balance of these two weights was compared with the predicted usage as a check that the doses had been administered correctly. Formulations were stirred before and throughout the dosing procedure.

Doses:

2000 mg/kg

No. of animals per sex per dose:

3 female rats/dose

Control animals:

no

Details on study design:

One group of three animals was treated as follows:

Dose level (mg/kg): 2000
Dose volume (mL/kg): 10
Number of rat (female): 3

In the absence of mortality or toxicity at a dose level of 2000 mg/kg, an additional group of three animals was treated as follows:
Dose level (mg/kg): 2000
Dose volume (mL/kg): 10
Number of rat (female): 3

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths during the study.

Clinical signs:

other: other: There were no clinical signs of reaction to treatment throughout the study.

Body weight:

other body weight observations

Remarks:

All animals were considered to have achieved satisfactory body weight gains throughout the study.

Other findings:

Macroscopic Examination

No abnormalities were noted in any animal at the macroscopic examination at study
termination on Day 15.

Table 1 – individual and group mean body weight (g)

Dose (mg/kg)	Sex	Animal Number	Body weight(s) at Day
			1*	8	15
2000	Female	41	163	186	199
		42	174	203	209
		43	170	201	215
		Mean	169	197	208
2000	Female	44	167	183	202
		45	170	190	210
		46	179	209	225
		Mean	172	194	212

* Prior to dosing

 

Table 2 – individual body weight change (g)

Dose (mg/kg)	Sex	Animal Number	Body weight(s) at Day
			1-8	8-15
2000	Female	41	23	13
		42	29	6
		43	31	14
2000	Female	44	16	19
		45	20	20
		46	30	16

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Under the conditions of the study, the acute median lethal oral dose (LD50) to rats of AA- 948- 61 (Decarboxylated Rosin, CAS no. 8050-18-8) was demonstrated to be greater than 2000 mg/kg body weight. AA-948-61 (Decarboxylated Rosin, CAS no. 8050-18-8) is included in Category 5/Unclassified, according to the Globally Harmonised System (GHS).

Executive summary:

The study was performed to assess the acute oral toxicity of AA-948-61 (Decarboxylated Rosin, CAS No. 8050-18-8) to the rat. A group of three fasted female rats received a single oral gavage dose of the test item, formulated in corn oil, at a dose level of 2000 mg/kg body weight. As results at this dose level indicated the acute lethal oral dose of the test item to be greater than 2000 mg/kg body weight, in compliance with the study guidelines, a further group of three fasted females was similarly dosed at 2000 mg/kg body weight to complete the study. During the study, clinical condition, body weight and macropathology investigations were undertaken. Under the conditions of the study, the acute median lethal oral dose (LD50) to rats of AA-948- 61 (Decarboxylated Rosin, CAS No. 8050-18-8) was demonstrated to be greater than 2000 mg/kg body weight. AA-948-61 (Decarboxylated Rosin, CAS No. 8050-18-8) is included in Category 5/Unclassified, according to the Globally Harmonised System (GHS).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Justification for classification or non-classification

Decarboxylated Rosin (CAS No. 8050 -18 -8) is not classified as hazardous according to the CLP Regulation