Alkenes, C15-18-branched and linear, maleated, hydrolyzed

Endpoint summary

Description of key information

An acute oral toxicity study was carried out according to OECD guideline 420. A group of five female Wistar rats were administered a single oral dose of Hydrolysed reaction products of furan-2,5-dione and C15-18-(linear and branched)-alkenes, suspended in distilled water. Neither death nor signs of toxicity were reported during the course of the study.

Acute oral toxicity LD50 > 2000 mg/kg bw for rat (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:

19 January 2010 to 4 February 2010

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

GLP compliance:

yes (incl. QA statement)

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK limited, Bicester, Oxon, K
- Age at study initiation: 8 to 12 weeks of age
- Weight at study initiation:
- Fasting period before study: Overnight fast prior to dosing and for approximately three to four after dosing
- Housing: Animals were housed in groups of four in suspended solid-floor polypropylene cages.
- Diet (e.g. ad libitum): Ad libitum except during fasting.
- Water (e.g. ad libitum): Free access to drinking water
- Acclimation period: At least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 C
- Humidity (%): 30-70%
- Air changes (per hr): At least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark and 12 hours light


IN-LIFE DATES: From: 19 January 2010 To: 4 February 2010

Route of administration:

oral: gavage

Vehicle:

other: Suspension in distilled water

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made at 0.5 hour, 1, 2 and 4 hours after dosing and once daily thereafter. Individual bodyweights were recorded on Day 0, 7 and 14.
- Necropsy of survivors performed: Yes, all animals were subjected to gross necropsy
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Mortality and viability were checked twice daily

Statistics:

No statistical method was used.

Preliminary study:

One animal was chosen as starting dose and administered 2000 mg/kg bw. Since no effects were observed an additional 4 animals were treated with that dose level.

Key result

Sex:

female

Dose descriptor:

approximate LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

There were no deaths

Clinical signs:

other: No signs of systemic toxicity were noted

Gross pathology:

No abnormalities were noted at necropsy

Other findings:

No other findings were reported

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the absence of any signs of toxicity, the acute oral median lethal dose (LD50) of the test material in female Wistar rats was estimated to be greater than 2000 mg/kg bw.

Executive summary:

A group of 5 female Wistar rats was administered a single oral dose of Hydrolysed reaction products of furan-2,5-dione and C15-18-(linear and branched)-alkenes suspended in distilled water by gavage at 2000 mg/kg bw. Moratlity was checked twice daily for 14 days. Clinical observations were made at 0.5 hour, 1, 2 and 4 hours after dosing and once daily thereafter. Individual bodyweights were recorded on Day 0, 7 and 14. Gross necropsy was carried out at the end of the study. Neither deaths, signs of systemic toxicity nor abnormalities occurred. All animals gained weight during the study and low increases in bodyweight were not deemed to be treatment related. Teh acute oral median lethal dose (LD50) of Hydrolysed reaction products of furan-2,5-dione and C15-18-(linear and branched)-alkenes in females Wistar rat was estimated to be greater than 2000 mg/kg bw. On this basis, Hydrolysed reaction products of furan-2,5-dione and C15-18-(linear and branched)-alkenes does not warrant any classification according to Regulation (EC) No 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

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

Pooles (2010) investigated the potential acute toxic effects of Hydrolysed reaction products of furan-2,5-dione and C15-18-(linear and branched)-alkenes to female Wistar rats following exposure by oral gavage. One group of 5 female rats were administered a single dose of Hydrolysed reaction products of furan-2,5-dione and C15-18-(linear and branched)-alkenes in suspended distilled water at a dose level of 2000 mg/kg bw. The rats were then observed for 14 days following test article administration. No death occurred during the course of the study. There was no signs of toxicity and all animals gained weight at the end of the study. No abnormalitites were recorded at necropsy. Therefore, the LD₅₀of Hydrolysed reaction products of furan-2,5-dione and C15-18-(linear and branched)-alkenes was estimated to be greater than 2000 mg/kg bw.

Justification for classification or non-classification

Based on the absence of any systemic effects in the acute oral study, the LD50 of Hydrolysed reaction products of furan-2,5-dione and C15-18-(linear and branched)-alkenes was estimated to be greater than 2000 mg/kg bw. On this basis, Hydrolysed reaction products of furan-2,5-dione and C15-18-(linear and branched)-alkenes does not warrant any classification according to Regulation (EC) No 1272/2008.