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Description of key information

The study was performed to determine the acute oral toxicity of the test item Tall Oil Pitch, reaction product with triethylene glycol in the female Wistar rat. The study was performed according to the OECD Guideline 420 and under GLP conditions.

A single dose of 2000 mg/kg bw was administered to female Wistar rat via oral gavage. Clinical signed and body weight changes were monitored during the study. All animals were subjected to gross necropsy. There were no deaths during the length of the study. No signs of systemic toxicity were observed. The body weight were in the normal values. No abnormalities were recorded in the necropsy.

In conclusion, according to the results of this study, the acute oral median lethal dose (LD50) of the test item was found to be greater than 2000 mg/kg/bw, therefore the substance is unclassified.

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:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
Identification: Tall Oil Pitch, reaction product with triethylene glycol
CAS Number: 2135769-54-7
CAS Nme: Tall oil pitch, ester with triethylene glycol
Batch: LABO 16-02
Purity: 100%
Physical state: brown viscous liquid
Expiry date: 14/11/2018
Storage conditions: room temperature in the dark under nitrogen
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon, UK
- Allocation on receipt: random
- Acclimatation: 5 days
- Age: 8-12 weeks
- Body weight variation: not more that +/-20%
- Housing: groups of up to four in suspended solid - floor polypropylene cages furnished with woodflakes.
- Diet: free access
- Water: free acess

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): 15 per hr
- Photoperiod (hrs dark / hrs light): 12 light / 12 dark
Route of administration:
oral: gavage
Details on study design:
Starting dose: 2000 mg/kg/bw

A single animal was treated as follows:
- Dose level: 2000 mg/kg/bw
- Concentration: 200 mg/mL
- Dose Volume: mL/kg
- Number of rat / female: 1
In the absence toxicity at a dose level of 2000 mg/kg, an additional group of animal was treated as follows:
- Dose level: 2000 mg/kg/bw
- Concentration: 200 mg/mL
- Dose Volume: mL/kg
- Number of rat / female: 4

A total of five animals were therefore treated at a dose level of 2000 mg/kg in the study.

All animals were dosed once by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing. Treatment of animals was sequential.

Sufficient time was allowed between each dose group to confirm the survival of the previously dosed animals.

Clinical observations were made 30 minutes, 1, 2 and 4 hours after dosing and then daily for up to 14 days. Morbidity and mortality checks were made twice daily, early and late during normal working days, and once daily at weekends and public holidays.

Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.

At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other:
Mortality:
There were no deaths
Clinical signs:
No signs of systemic toxicity were noted
Body weight:
No changes compered to the controls
Gross pathology:
No abnormalities were noted
Other findings:
No abnormalities were noted
Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the femal Wistar strain rats was determied to be greated than 2000 mg/bw bw.
Executive summary:

The study was performed to determine the acute oral toxicity of the test item Tall Oil Pitch, reaction product with triethylene glycol in the female Wistar rat. The study was performed according to the OECD Guideline 420 and under GLP conditions.

A single dose of 2000 mg/kg bw was administered to female Wistar rat via oral gavage. Clinical signed and body weight changes were monitored during the study. All animals were subjected to gross necropsy. There were no deaths during the length of the study. No signs of systemic toxicity were observed. The body weight were in the normal values. No abnormalities were recorded in the necropsy.

In conclusion, according to the results of this study, the acute oral median lethal dose (LD50) of the test item was found to be greater than 2000 mg/kg/bw, therefore the substance is unclassified.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Key study - K1 - GLP - Accoring to OECD TG 430

Additional information

Justification for classification or non-classification