Fatty acids, C16-18 (even numbered, C18 unsaturated), 2-ethylhexyl esters, epoxidized

Endpoint summary

Description of key information

The test substance was subjected to an acute oral toxicity study, performed in accordance with OECD Guideline 401 (no GLP). The study showed a LD50 of >2000 mg/kg.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(adopted 1981)

Deviations:

yes

Remarks:

Use of 2000 mg/kg bw as limit dose. Use of 2 animals per sex.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

- Chemical name: 2-Ethylhexyl-Epoxystearate
- Physical state: liquid, light yellow

Species:

rat

Strain:

Wistar

Remarks:

TNO

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen (district Paderborn)
- Age at study initiation: 152 g (females), 174 g (males)
- Weight at study initiation: at least 6 weeks
- Fasting period before study: 15 hours before treatment until 3 hours post-treatment
- Housing: 2 rats per Makrolon cage (type III)
- Diet: Altromin 1324 pellets, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23
- Humidity (%): 50-70
- Photoperiod: 12 hrs dark / 12 hrs light

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

2%

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg

MAXIMUM DOSE VOLUME APPLIED:
10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations for mortality and symptoms: Several times at the day of application, twice daily afterwards.
- Frequency of weighing: Day -1 before fasting, day of application as well as 48 hours, 1 week, and 2 weeks after application.
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: Directly after application: piloerection, lethargy Day 2-3: lethargy

Gross pathology:

No findings.

Table 1: Development of body weights of rats during the acute oral toxicity study.

Animal No.	Sex	Day -1	Day of application	Day 2	Day 7	Day 14
1	Male	182	173	184	203	236
2	Male	190	175	186	208	228
1	Female	155	149	157	164	166
2	Female	164	154	160	156	169

 

Interpretation of results:

GHS criteria not met

Conclusions:

No mortality occurred and no gross pathology findings were observed.

Executive summary:

In an acute oral toxicity study equivalent to OECD TG 401 (adopted 1981, no GLP), the test substance was administered by oral gavage to two Wistar rats of each sex at 2000 mg/kg bw as a limit dose. All animals were weighed prior to dosing and at termination. They were observed frequently on the day of dosing and daily for a total of 15 days. Clinical signs of toxicity, body weights as well as gross pathological findings were recorded. Directly after application piloerection and lethargy were observed as clinical signs. Lethargy was present at day 2 and 3 after administration. No animals died on account of the treatment nor did they show severe signs of toxicosis in the 14 observation period. The oral LD50 value of the test substance in Wistar rats was established as greater than 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

Comparable to guideline study with acceptable restrictions

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

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

Quality of whole database:

In accordance with column 2 of REACH Annex VIII, testing of the acute toxicity by inhalation is not appropriate as the substance is a liquid with a low vapour pressure (<= 3.6*10-8 atm ( <= 3.7*10-3 Pa; <= 3. 7*10-5 mbar) at 20°C) and inhalation of the substance is unlikely.

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)

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

The study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (see chapter 7.3.1 Skin irritation and 7.4.1 Skin sensitation).

Additional information

Acute toxicity, oral

In an acute oral toxicity study equivalent to OECD TG 401 (adopted 1981, no GLP), the test substance was administered by oral gavage to two Wistar rats of each sex at 2000 mg/kg bw as a limit dose. All animals were weighed prior to dosing and at termination. They were observed frequently on the day of dosing and daily for a total of 15 days. Clinical signs of toxicity, body weights as well as gross pathological findings were recorded. Directly after application piloerection and lethargy were observed as clinical signs. Lethargy was present at day 2 and 3 after administration. No animals died on account of the treatment nor did they show severe signs of toxicosis in the 14 observation period. The oral LD50 value of the test substance in Wistar rats was established as greater than 2000 mg/kg bw (Henkel 1983).

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No mortality occurred at the limit dose of 2000 mg/kg bw. As a result, the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.