Fatty acids, tall-oil, reaction products with pentaethylenehexamine

Endpoint summary

Description of key information

A single dose of the test item was administered orally or dermally to Wistar rats at concentrations of 2000 mg/kg bw. No mortality occurred. Clinical examiniation and gross necropsy did not reveal any findings. Application onto skin caused erythema, edema, incrustations and scaling. The LD50 after oral and dermal administration is therefore considered to be > 2000 mg/kg bw.

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:

2012

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

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:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 160-250g
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5d
- Fasting: 16h before administration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: September 13, 2012 To: October 2nd, 2012

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw, 2.13 ml/kg bw

DOSAGE PREPARATION (if unusual): For a better homogeneity the test item was heated at 40°C for approx. 1 hour. The test item was administrated hand warm.

Doses:

single administration of 2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed individually for behaviour changes or signs of toxicity <0.5, 1, 2, 3, 4 and 5 hours after dosing at the day of administration and at least once daily thereafter. Clinical observations were performed at least once each workday and recorded individually. Individual body weight was determined shortly before test item administration, at approx. weekly intervals thereafter and before the sacrifice of the animals at the end of the observation period. A check for moribund and dead animals was made at least once each workday.
- Necropsy of survivors performed: yes
- Other examinations performed: On the last day of the observation period, the animals were sacrificed by CO2-inhalation in a chamber with increasing concentrations over time, followed by necropsy and gross-pathological examination.

Statistics:

no

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no mortality occured

Clinical signs:

other: Impaired general state, dyspnoea, piloerection (first test group); no signs (second group)

Gross pathology:

There were no macroscopic pathological findings at the end of the observation period.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: male animals approx. 8 - 10 weeks, female animals approx. 12 - 14 weeks
- Weight at study initiation: 200-300g
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5d
- Fasting: 16h before administration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: September 13, 2012 To: October 2nd, 2012

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal and dorsolaterale parts of the trunk
- % coverage: 10

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing of the application site with luke warm water
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.13 ml/kg bw
- Concentration (if solution): 100%
- Constant volume or concentration used: yes

For a better homogeneity the test item will be heated at 40°C for approx. 1 hour. The test item will be administrated hand warm.

Duration of exposure:

24h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed individually for behaviour changes or signs of toxicity <0.5, 1, 2, 3, 4 and 5 hours after dosing at the day of administration and at least once daily thereafter. Clinical observations were performed at least once each working-day and recorded individually. Individual body weight was determined shortly before test item administration, at weekly intervals thereafter and before the sacrifice of the animals at the end of the observation period. A check for moribund and dead animals was made at least once each work-day.
- scoring: Individual recording of findings 30 - 60 minutes after removal of the semi- occlusive dressing; afterward, at approx. weekly intervals and on the last day of observation.
- Necropsy of survivors performed: yes
- Other examinations performed: On the last day of the observation period, the animals were sacrificed by CO2-inhalation in a chamber with increasing concentrations over time, followed by necropsy and gross-pathological examination.

Statistics:

no

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality observed.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

Other findings:

The following test item-related local effects were recorded during the course of the study:

oVery slight to severe erythema (grade 1 to 4)
o Very slight to severe edema (grade 1 to 4)
o Incrustations
o Scaling

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

A single dose of the test item was administered by gavage to female Wistar rats at concentrations of 2000 mg/kg bw. The animals were observed for 14 days. Mortality, body weight and clinical signs were recorded continuously. Organ weighing and gross necropsy was performed after scheduled sacrifice.

A single dose of the test item was applied onto skin of male and female Wistar rats at concentrations of 2000 mg/kg bw. The animals were observed for 14 days. Mortality, body weight and clinical signs were recorded continuously. Organ weighing and gross necropsy was performed after scheduled sacrifice.

 

No mortality occurred, body weight and body weight gain were comparable to control animals. Clinical signs of toxicity were not observed and gross necropsy did not reveal any findings. Application onto skin caused erythema, edema, incrustations and scaling. The oral and dermal LD50 is therefore considered to be > 2000 mg/kg bw.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008, as amended for the 14th time in Regulation (EU) 2020/217.