Fatty acids C16-18 (even numbered), mono and di esters with Sucrose

Endpoint summary

Description of key information

Oral (OECD 401), rat: > 2000 mg/kg bw (limit test)

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:

08 May - 22 May 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted Feb 24, 1987

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Commission Directive No 92/69/EEC of July 31, 1992

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Remarks:

Hoe: W1SKf(SPF71)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst Aktiengesellschaft, Kastengrund, Germany; SPF breeding colony
- Age at study initiation: 6 - 8 weeks (males) and 7 - 10 weeks (females)
- Weight at study initiation: 163 - 175 g (males) and 162 - 173 g (females)
- Fasting period before study: from 16 h before to 3 - 4 h after treatment
- Housing: in groups of 5 animals in macrolon cages (type 4) on soft wood granulate
- Diet: ssnitt® R/M-H (V 1534), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least one day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): fully air-conditioned
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

other: deionised water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10%
- Amount of vehicle: 20 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for clinical signs twice a day (in the morning and in the afternoon), on weekends and public holidays only once. Body weights were determined weekly.
- Necropsy of survivors performed: yes

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

Gross pathology revealed no substance-related findings.

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

In this acute oral toxicity study a LD50 value of > 2000 mg/kg bw was derived in male and female rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises adequate, reliable (Klimisch score 1) and consistent studies, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Oral

The acute oral toxicity of the test substance was assessed in a study according to OECD Guideline 401 (Jensch, 1996), conducted in compliance with GLP. The test substance was applied via gavage as 10% dilution in deionized water. A dose of 2000 mg/kg bw (limit test) test substance was administered to 5 male and 5 female rats. Animals were observed for mortality and general clinical condition twice daily for 14 days. Body weights were recorded on the day of administration (Day 1) and on Days 8 and 15 thereafter. Macroscopic examination was performed in the end of the observation period at terminal sacrifice. None of the animals died and no clinical symptoms were observed during the study. The body weight gain was not affected by the administration of the test substance. No pathological findings were observed at necropsy. Based on the results of this study, the oral LD50 value was determined to be > 2000 mg/kg bw in rats.

In a supporting study, the acute oral toxicity was assessed in a study equivalent to OECD Guideline 401 with limited documentation (Bouffechoux, 1995). A single oral dose of 2000 mg/kg bw (limit test) was given to 5 female Swiss mice. Animals were observed for mortality, body weight, general clinical signs and behavior for 14 days. None of the animals died and no clinical symptoms or changes in behavior were observed during the study. The body weight gain was not affected by the administration of the test substance. Based on the results of this study, the oral LD50 value was determined to be > 2000 mg/kg bw in rats. This study was not taken into account for hazard assessment.

Justification for classification or non-classification

The available data on acute oral toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification