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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18/5/15 to 4/6/15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
methyl 2-fluoroprop-2-enoate
EC Number:
607-233-2
Cas Number:
2343-89-7
Molecular formula:
C4H5FO2
IUPAC Name:
methyl 2-fluoroprop-2-enoate
Test material form:
other: Light brown liquid
Details on test material:
- Name of test material (as cited in study report): 2-Propenoic acid, 2-fluoro, methyl ester, EC Number: 607-233-2
- Physical state: Light brown liquid
- Analytical purity: 98.7 %
- Lot/batch No.: 03026-20140801
- Expiration date of the lot/batch: 27 August 2015
- Storage condition of test material: Approximately 4 °C under nitrogen in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: At least 200 g, weight variation did not exceed ±20% of the mean weight
- Fasting period before study: None
- Housing: uspended solid floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): Free access to 2014C Teklad Global Rodent diet
- Water (e.g. ad libitum): Free access to mains drinking water
- Acclimation period: At least 5 days

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Shorn skin, precise location not specified
- % coverage: 10 % of the total body surface
- Type of wrap if used: surgical gauze, semi-occluded with a piece of self-ashesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with cotton wool and arachis oil BP
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Constant volume or concentration used: yes
Duration of exposure:
24 hours
Doses:
Single dose test
No. of animals per sex per dose:
Five
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30 minutes, 1 hour, 2 hours and 4 hours after dosing and subsequently daily for the observation period
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
There were no deaths.
Clinical signs:
other: No signs of systemic toxicity were noted during the observation period.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
There were no signs of dermal irritation

Any other information on results incl. tables

Table 1 - Individual Clinical Observations and Mortality Data

              Effects Noted After Dosing (Hours)                        Effects Noted During Period After Dosing (Days)                 
 Dose Level (mg/kg) Animal Number and Sex   0.5 1  2  4  1  2  3  4  5  6  7  8  9  10  11  12  13  14 
 2000 1 -0 Male  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 3 -0 Male  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 3 -1 Male  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 3 -2 Male  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 3 -3 Male  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 2 -0 Female  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 4 -0 Female  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 4 -1 Female  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 4 -2 Female  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 4 -3 Female  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0 

Table 2 - Individual Dermal Reactions: Males

     

Effects Noted After Initiation of Exposure (Days)
 Dose Level (mg/kg) Animal Number and Sex  Observation  1 2  3  4  5  6  7  8  9  10  11  12  13  14 
 2000 1 -0 Male  Erythema  0 0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 1 -0 Male  Edema  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 1 -0 Male  Other  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 3 -0 Male  Erythema  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 3 -0 Male  Edema  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 3 -0 Male  Other  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 3 -1 Male  Erythema  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 3 -1 Male  Edema  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 3 -1 Male  Other  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 3 -2 Male  Erythema  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 3 -2 Male  Edema  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 3 -2 Male  Other  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 3 -3 Male  Erythema  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 3 -3 Male  Edema  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 3 -3 Male  Other  0  0  0  0  0  0  0  0  0  0  0  0  0  0 

Table 3 - Individual Dermal Reactions: Females

       Effects Noted After Initiation of Exposure (Days)
 Dose Level (mg/kg) Animal Number and Sex  Observation  1  2  3  4  5  6  7  8  9  10  11  12  13  14 
 2000 2 -0 Female  Erythema  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 2 -0 Female  Edema  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 2 -0 Female  Other  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 4 -0 Female  Erythema  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 4 -0 Female  Edema  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 4 -0 Female  Other  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 4 -1 Female  Erythema  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 4 -1 Female  Edema  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 4 -1 Female  Other  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 4 -2 Female  Erythema  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 4 -2 Female  Edema 0   0 0  0  0  0  0  0  0  0  0  0  0  0 
 2000 4 -2 Female  Other  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 4 -3 Female  Erythema  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 4 -3 Female  Edema  0  0  0  0  0  0  0  0  0  0  0  0  0  0 
 2000 4 -3 Female  Other  0  0  0  0  0  0  0  0  0  0  0  0  0  0 

Table 4 - Individual Body Weights and Body Weight Changes

     Body Weight (g) at Day  Body Weight Change (g) During Week
 Dose Level (mg/kg) Animal Number and Sex  0  7  14  1  2 

 2000

 1 -0 Male  228  240  262  12  22 
 2000 3 -0 Male  226  241  260  15  19 
 2000 3 -1 Male  236  246  269  10  23 
 2000 3 -2 Male  242  261  284  19  23 
 2000 3 -3 Male  230  243  262  13  19 
 2000 2 -0 Female  211  214  217  3  3 
 2000 4 -0 Female  214  214  224  0  10 
 2000 4 -1 Female  220  219  234  -1  15 
 2000 4 -2 Female  213  217  223  4  6 
 2000 4 -3 Female  214  212  221  -2  9 

Table 5 - Individual Necropsy Findings

 Dose Level (mg/kg)  Animal Number and Sex Time of Death  Macroscopic Observations 
 2000 1 -0 Male  Killed Day 14 

No abnormalities detected 
 2000 3 -0 Male  Killed Day 14   No abnormalities detected  
 2000 3 -1 Male  Killed Day 14   No abnormalities detected  
 2000 3 -2 Male  Killed Day 14   No abnormalities detected  
 2000 3 -3 Male  Killed Day 14   No abnormalities detected  
 2000 2 -0 Female  Killed Day 14   No abnormalities detected  
 2000 4 -0 Female  Killed Day 14   No abnormalities detected  
 2000 4 -1 Female  Killed Day 14   No abnormalities detected  
 2000 4 -2 Female  Killed Day 14   No abnormalities detected  
 2000  4 -3 Female Killed Day 14   No abnormalities detected  

Applicant's summary and conclusion

Interpretation of results:
not classified
Conclusions:
The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight. The substance is not classified according to the CLP Regulation (EU) 1272/2008.
Executive summary:

Introduction

The study was performed to assess the acute dermal toxicity of the test item in the Wistar strain rat.

Methods

Initially, two animals (one male and one female) were given a single, 24 hour, semi-occluded dermal application of the undiluted test item to intact skin at a dose level of 2000 mg/kg body weight. Based on the results of the initial test, a further group of eight animals (four males and four females) was similarly treated. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

Results

Mortality. There were no deaths.

Clinical Observations. There were no signs of systemic toxicity.

Dermal Irritation. There were no signs of dermal irritation.

Body Weight. Three females showed body weight loss or no gain in body weight during the first week with expected gain in body weight during the second week. The remaining animals showed expected gains in body weight over the study period.

Necropsy. No abnormalities were noted at necropsy.

Conclusion

The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.