Oligo

Endpoint summary

Description of key information

Acute oral toxicity (OECD 401): LD50 > 2000 mg/kg bw in male and female rats

Acute dermal toxicity (OECD 402, read across): LD50 > 2000 mg/kg bw in male and female rats

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:

21 May - 18 Jun 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 in 1987

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted in 1992

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Remarks:

Hoe: WISKf(SPF71)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst Aktiengesellschaft, Kastengrund, SPF breeding colony
- Age at study initiation: males ~7 weeks, females ~8 weeks
- Weight at study initiation: males: 173-179 g, females 159-170 g
- Fasting period before study: from about 16 hours before to 3 - 4 hours after treatment
- Housing: in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet: commercial diet ( ssniff R/M-H (V 1534)), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least one day (breeding at identical conditions)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 21 May 1996 - 04 Jun 1996

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE: The animals received the compound as a 20 % solution in sesame oil.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION: The test substance was dissolved in the stated concentration in sesame oil and distributed homogeneously by means of a magnetic stirrer. The stability and the homogeneity of the test substance in the vehicle was determined by analytical methods.

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: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once.
- Frequency of weighing: once a week
- Necropsy of survivors performed: yes

Key result

Sex:

male/female

Dose descriptor:

LD50

Remarks:

rat

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: All animals showed swollen abdomen on the first day after administration, which was fully resolved within 2 days.

Gross pathology:

No macroscopically visible changes were seen during necropsy performed at the end of observation period.

Interpretation of results:

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises an adequate and reliable study (Klimisch score 1), 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

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

Refer to analogue justification provided in IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Clinical signs:

other:

The acute dermal toxicity study with the source substance Fatty acids C16-18 (even numbered), mono, di and triesters with sucrose (no CAS) was selected as key result for reasons of high structural similarity and data reliability.

Interpretation of results:

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

Conclusions:

The read across approach is justified in the analogue justification. The target and source substances are considered unlikely to differ in their acute toxicity potential. The acute dermal LD50 in male and female rats was found to be ≥ 2000 mg/kg bw for the source substance Fatty acids C16-18 (even numbered), mono, di and triesters with sucrose (no CAS). Therefore, an acute dermal LD50 value of 2000 mg/kg bw was considered for the hazard assessment and C&L purposes for the target substance Fatty acids C16-18(even numbered), oligoesters with sucrose (no CAS).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises an adequate and reliable (Klimisch score 1) study from an structural analogue source substance with very similar structure and intrinsic properties. Read-across is justified based on common precursors and breakdown products of hydrolysis and consistent trends in environmental fate, ecotoxicological and toxicological profile. The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.

Additional information

Acute oral toxicity

The acute oral toxicity of the test substance Fatty acids C16-18(even numbered), oligoesters with sucrose (no CAS) was assessed in male and female rats in a study performed according to OECD Guideline 401 under GLP conditions (key study, 1996). The test substance was applied via gavage as 20% solution in sesame oil. A dose of 2000 mg/kg bw (limit test) was administered to five female and five male rats. No deaths occurred during the study. All animals showed swollen abdomen on the first day after administration, which was fully resolved on day 2. Development of body weight was not affected. No macroscopically visible changes were seen during necropsy performed at the end of observation period. Based on the study results, the oral LD50 value was > 2000 mg/kg bw.

Acute dermal toxicity

The acute dermal LD50 was found to be ≥2000 mg/kg bw for the source substance Fatty acids C16-18 (even numbered), mono, di and triesters with sucrose (key study, 2015). The target and source substances are considered unlikely to differ in their acute toxicity potential. Therefore, an acute dermal LD50 value of 2000 mg/kg bw was considered for the hazard assessment and C&L purposes for the target substance Fatty acids C16-18(even numbered), oligoesters with sucrose (no CAS).

Justification for classification or non-classification

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