Tall oil, polymd., oxidized

Endpoint summary

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:

2017

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)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Species:

rat

Strain:

Wistar

Sex:

female

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

The test item was administered at a dose volume of 10 mL/kg body weight.

Doses:

Dosage of 300 mg/kg body weight. The test item was suspended with the vehicle corn oil at a concentration of 0.03 g/mL and administered at a dose volume of 10 mL/kg.
Dosage of 2000 mg/kg body weight. The test item was suspended with the vehicle corn oil at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg.

No. of animals per sex per dose:

6 Female rats/ 300 mg/kg body weight
6 Female rats/ 2000 mg/kg body weight

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: once daily
- Frequency of weighing: on day 1 (prior to the administration) and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

ca. 5 000 mg/kg bw

Mortality:

The test item showed no mortality.

Clinical signs:

other: The most relevant clinical findings in the animals treated with the test item at a dose of 300 mg/kg bw were reduced spontaneous activity, piloerection, half eyelid-closure and hunched posture. All animals recovered within up to 2 days post-dose. The most

Gross pathology:

No specific gross pathological changes were recorded for any animal.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the present study, a single oral application of the test item Tall oil, polym., oxidized to rats at a dose of 300 mg/kg body weight was associated with signs of toxicity but not mortality.
Under the conditions of the present study, a single oral application of the test item Tall oil, polym., oxidized to rats at a dose of 2000 mg/kg body weight was associated with signs of toxicity but not mortality.
The median lethal dose of Tall oil, polym., oxidized after a single oral administration to female rats, observed over a period of 14 days is:
LD50 cut-off (rat): 5000 mg/ kg bw

Executive summary:

Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 300 mg/kg body weight. The test item was suspended with the vehicle corn oil at a concentration of 0.03 g/mL and administered at a dose volume of 10 mL/kg.

Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was suspended with the vehicle corn oil at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg.

All animals used in the study after their entrance at BSL were allowed to acclimatise to the laboratory conditions for at least 5 days. The animals were observed on delivery, on inclusion in the study and before administration for mortality/morbidity and other clinical signs. All animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period. Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.

All animals survived until the end of the study showing signs of toxicity.

The most relevant clinical findings in the animals treated with the test item at a dose of 300 mg/kg bw were reduced spontaneous activity, piloerection, half eyelid-closure and hunched posture. All animals recovered within up to 2 days post-dose.

The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, piloerection, half eyelid-closure, hunched posture and sunken flanks. All animals recovered within up to 3 days post-dose.

Throughout the 14-day observation period, the weight gain of the animals was within the normal range of variation for this strain.

Macroscopic findings of animals:

At necropsy, no treatment-related macroscopic findings were observed in any animal of any step.

Endpoint conclusion

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

- Lot/batch No.: 2005-06-09, sample 4.
- Storage condition of test material: Room temperature, in the dark.

Species:

rat

Strain:

other: CRL: CD(SD)BR SPF

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland
- Age at study initiation: Males: 8 weeks. Females: 12 weeks.
- Weight at study initiation: Males: 270 - 284 g. Females: 245 - 252g.
- Fasting period before study: No
- Housing: Individually in Makrolon cages Type III
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 (average)
- Humidity (%): 67 (average)
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 09.08.05 To: 25.08.05

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 52 cm2
- % coverage: 10% of estimated body surface.
- Type of wrap if used: Cellulose patch was held in place by a non-irritating tape. The patch and tape were covered semi-occlusively by a dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with wet cellulose tissue.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Five

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed 0-0.5, 0.5-1, 1-2, 2-4 and 4-6 hours after administration of the test substance and then at least once per day for two weeks. Body weights were recorded before administration and on Days 7 and 14.
- Necropsy of survivors performed: yes

Statistics:

None

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: No deaths occurred

Mortality:

All animals survived until scheduled termination of the study.

Clinical signs:

other: There were no clinical signs of toxicity.

Gross pathology:

There were no abnormal findings during the gross pathological examination.

Other findings:

No other findings.

Interpretation of results:

GHS criteria not met

Conclusions:

In a good quality acute dermal toxicity study (reliability score 1) conducted to OECD test guideline 402, and GLP, the LD50 for Crude Tall Oil was greater than 2000 mg/kg bw in Crl:CD(SD)IGS BR rats.

Executive summary:

A single dermal administration of Crude Tall Oil was performed, by spreading the test substance on an area of skin that was at least 10% of the estimated body surface of male and female CRL: CD(SD)BR SPF rats. 2000 mg/kg bw of the test substance was held in place with a semi-occlusive dressing for 24 hours. At the end of the exposure period the residual test substance was wiped off with a wet cellulose tissue, when necessary. The animals were then observed for 14 days. Clinical observations were noted at least once per day, body weights were recorded before administration, and on days 7 and 14. At the end of the observation period all animals were sacrificed and necropsied. There were no clinical signs of toxicity, no deaths and there were no treatment-related effects on body weight. The dermal LD₅₀was therefore greater than 2000 mg/kg bw.

Reference 2

Endpoint:

acute toxicity: dermal

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Justification for type of information:

See attached read-across justification report

Reason / purpose for cross-reference:

read-across source

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: No deaths occured

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 for Tall oil, polymerized, oxidized is estimated to be greater than 2000 mg/kg bw, based on the result of the source study (see read across justification report).

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Justification for classification or non-classification

The available data for acute oral and dermal toxicity in the rat indicate that Tall Oil, polymd. oxidized is not classified for acute toxicity according to the criteria of Regulation 1272/2008.

There are no data available for the inhalation route.