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

Acute Toxicity: oral

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(6E)-3,13-diethylpentadec-6-ene; (6E)-tetradec-6-ene; (7E)-hexadec-7-ene; (8E)-nonadec-8-ene; 2-[(6E)-3,13-diethylpentadec-6-en-8-yl]butanedioic acid; 2-[(8E)-nonadec-8-en-7-yl]butanedioic acid; 2-[(8E)-tetradec-8-en-7-yl]butanedioic acid; 2-[(9E)-hexadec-9-en-8-yl]butanedioic acid

EC Number:

700-363-1

Cas Number:

1335203-20-7

IUPAC Name:

(6E)-3,13-diethylpentadec-6-ene; (6E)-tetradec-6-ene; (7E)-hexadec-7-ene; (8E)-nonadec-8-ene; 2-[(6E)-3,13-diethylpentadec-6-en-8-yl]butanedioic acid; 2-[(8E)-nonadec-8-en-7-yl]butanedioic acid; 2-[(8E)-tetradec-8-en-7-yl]butanedioic acid; 2-[(9E)-hexadec-9-en-8-yl]butanedioic acid

Details on test material:

- Name of test material (as cited in study report): Hydrolysed reaction products of furan-2,5-dione and C15-18-(linear and branched)-alkenes
- Physical state: Amber coloured extremely viscous liquid
- Lot/batch No.: AF405
- Storage condition of test material: Kept at room temperature in the dark

Test animals

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

Administration / exposure

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.

Results and discussion

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.

Effect levels

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

Applicant's summary and conclusion

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.