Fatty acids, tallow, compds. with triethanolamine

Endpoint summary

Description of key information

Acute oral toxicity

The LD50 of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight and as such requires no classification in accordance with EU criteria.

Acute Inhalation Toxicity

In accordance with Section 8.5.2. of Column 2 of Annex VIII of the REACH Regulation, the registrant proposes to waive the acute toxicity testing by the inhalation route on the basis that exposure to humans via inhalation is unlikely, taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

Acute Dermal Toxicity

In accordance with Section 8.5.3. of Column 2 of Annex VIII of the REACH Regulation, the registrant proposes to waive the acute toxicity testing by the dermal route on the basis that the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been seen in in vivo studies with dermal exposure (skin sensitisation).

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:

19 January 2016 to 16 February 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 8 to 12 weeks of old.
- Weight at study initiation: Body weights ranged from 145 to 187g. The body weight variation did not exceed ± 20 % of the mean body weight at the start of treatment.
- Fasting period: Yes. The animals had an overnight fast immediately before dosing and for approximately 3 to 4 hours after dosing.
- Housing: The animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with wood flakes.
- Diet: Ad libitum.
- Water: Ad libitum access to mains drinking water.
- Acclimation period: Period of at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C.
- Humidity (%): 30 to 70 %.
- Air changes (per hr): At least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness.

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg at the 300 mg/kg dose level in the sighting study and 2.18 mL/kg at the 2000 mg/kg dose level. The specific gravity (0.919) was determined and used to calculate the appropriate dose volume for the required dose level.

DOSAGE PREPARATION: For the purpose of administering the 2000 mg/kg dose level the test item was used as supplied.
For the purpose of administering the 300 mg/kg dose level the test item was freshly prepared, as required, as a solution in arachis oil BP. Arachis oil BP was used because the test item did not dissolve/suspend in distilled water.
The test item was formulated within 2 hours of being applied to the test system. It is assumed that the formulation was stable for this duration.
No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation.

Doses:

2000 mg/kg

No. of animals per sex per dose:

One female was treated at 300 mg/kg.
Five females were treated at 2000 mg/kg.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 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 14 days. Morbidity and mortality checks were made twice daily. Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: Yes. 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.

Preliminary study:

At a dose level of 300 mg/kg, there was no mortality and no signs of systemic toxicity were noted during the observation period. The animals showed expected gains in body weight over the observation period. No abnormalities were noted at necropsy.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: No signs of systemic toxicity were noted during the observation period.

Gross pathology:

Dark kidneys were noted at necropsy of the initial animal treated at 2000 mg/kg. No abnormalities were noted at necropsy of the additional four treated animals treated at this dose level.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the LD50 of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight and as such requires no classification in accordance with EU criteria.

Executive summary:

The acute oral toxicity of the test material was assessed in the Wistar strain rat in accordance with the standardised guidelines OECD 420 and EU Method B.1bis under GLP conditions.

Following a sighting test at dose levels of 300 mg/kg and 2000 mg/kg, a further group of four fasted females was given a single oral dose of test material at a dose level of 2000 mg/kg body weight. All animals were dosed once only 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. Sufficient time was allowed between each dose group to confirm the survival of the previously dosed animals. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

There were no deaths during the study. There were no signs of systemic toxicity observed and all animals showed expected gains in body weight. Dark kidneys were noted at necropsy of one animal treated at a dose level of 2000 mg/kg. However, no abnormalities were noted at necropsy of the remaining animals.

Under the conditions of this study, the LD50 of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight and as such requires no classification in accordance with EU criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The key study was conducted under GLP conditions in accordance with the standardised guidelines OECD 420 and EU Method B.1 bis. It was assigned a reliability score of 1 in accordance with the criteria detailed by Klimisch (1997).

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

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
In accordance with Section 8.5.2. of Column 2 of Annex VIII of the REACH Regulation, the registrant proposes to waive the acute toxicity testing by the inhalation route on the basis that exposure to humans via inhalation is unlikely, 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

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
In accordance with Section 8.5.3. of Column 2 of Annex VIII of the REACH Regulation, the registrant proposes to waive the acute toxicity testing by the dermal route on the basis that the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects were observed in the in vivo skin sensitisation study.

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity

The acute oral toxicity of the test material was assessed in the Wistar strain rat in accordance with the standardised guidelines OECD 420 and EU Method B.1bis under GLP conditions. The study was assigned a reliability score of 1 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).

Following a sighting test at dose levels of 300 mg/kg and 2000 mg/kg, a further group of four fasted females was given a single oral dose of test material at a dose level of 2000 mg/kg body weight. All animals were dosed once only 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 signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

All animals survived the oral exposure of the test material. There were no signs of systemic toxicity observed and all animals showed expected gains in body weight. Dark kidneys were noted at necropsy of one animal treated at a dose level of 2000 mg/kg. However, no abnormalities were noted at necropsy of the remaining animals.

Under the conditions of this study, the LD50 of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight and as such requires no classification in accordance with EU criteria.

Acute Inhalation Toxicity

In accordance with Section 8.5.2. of Column 2 of Annex VIII of the REACH Regulation, the registrant proposes to waive the acute toxicity testing by the inhalation route on the basis that exposure to humans via inhalation is unlikely, taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

Acute Dermal Toxicity

In accordance with Section 8.5.3. of Column 2 of Annex VIII of the REACH Regulation, the registrant proposes to waive the acute toxicity testing by the dermal route on the basis that the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (skin sensitisation).

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for acute oral toxicity.