2,2,3,3,4,4,5,5-octafluoropentyl methacrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 24, 2008 to August 28, 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Version / remarks:

Adopted December 17, 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

2002

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2,3,3,4,4,5,5-octafluoropentyl methacrylate

EC Number:

206-596-0

EC Name:

2,2,3,3,4,4,5,5-octafluoropentyl methacrylate

Cas Number:

355-93-1

Molecular formula:

C9H8F8O2

IUPAC Name:

2,2,3,3,4,4,5,5-octafluoropentyl 2-methylprop-2-enoate

Test material form:

liquid

Specific details on test material used for the study:

Purity: 99%
Specific Gravity: 1.49

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Boyertown, PA
- Females nulliparous and non-pregnant: yes
- Age at study initiation: ~8-9 weeks
- Weight at study initiation: 196-212 grams
- Fasting period before study: 16-20 hours prior to dosing
- Housing: 1/cage
- Diet: ad libitum, except for 16-20 hours prior to dosing
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: June 25, 2008 To: July 10, 2008

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 0.26-0.28 mL

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 females/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed 0.5, 1, 2, and 4 hours postdose and once daily for 14days for toxicity and pharmacological effects. All animals were observed twice daily for mortality. Body weights were recorded immediately pretest, weekly and at termination.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Not applicable

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality reported

Mortality:

All animals survided the 2000 mg/kg oral dose

Clinical signs:

other: Instances of wetness of the anogenital area, ataxia, prostration, flaccid muscle tone and coma were noted on the day of dosing. All animals appeared normal from day 1 through day 14.

Gross pathology:

Necropsy results were normal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

All animals survived the 2000 mg/kg oral dose with transient clinical signs observed during the day of dosing. The symptoms occurred quickly after dosing and were transient in nature. The acute oral LD50 is greater than 2000 mg/kg bw.

Executive summary:

The acute oral toxicity of the substance was investigated following a GLP compliant OECD Guideline 425 study. In total, five female non-pregnant and nulliparous Wistar albino rats were dosed with 2000 mg/kg bw of OFPMA according to up-and-down procedure. The rats were observed at 0.5, 1, 2, and 4 hours post dose and once daily for 14 days for toxicity and pharmacological effects. All animals were observed twice daily for mortality. Body weights were recorded immediately pretest, weekly and at termination. All animals were examined for gross pathology.

 

All animals survived the 2000 mg/kg bw oral dose with transient clinical signs observed during the day of dosing. Instances of wetness of the anogenital area, ataxia, prostration, flaccid muscle tone and coma were noted on the day of dosing. The symptoms occurred quickly after dosing and were transient in nature. All animals appeared normal from day 1 through day 14. Body weight changes were normal in 4/5 animals. One animal lost weight during the second week of the observation period. Necropsy results were normal.

 

The acute oral LD50 of the substance is greater than 2000 mg/kg bw.