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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: MAFF Japan Agricultural Chemicals Regulation Laws Notification 12 Nousan 8147 (2000)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
methyl (2E)-3-methoxy-2-[2-({[6-(trifluoromethyl)pyridin-2-yl]oxy}methyl)phenyl]acrylate
EC Number:
601-478-9
Cas Number:
117428-22-5
Molecular formula:
C18H16F3NO4
IUPAC Name:
methyl (2E)-3-methoxy-2-[2-({[6-(trifluoromethyl)pyridin-2-yl]oxy}methyl)phenyl]acrylate
Test material form:
solid
Details on test material:
Purity: 99.66%

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Inc., Raleigh, North Carolina.
- Age at study initiation: Males 12 and females 10 weeks old
- Weight at study initiation: Males: 393 to 465 g; Females: 209 to 246 g
- Housing: All animals were housed singly in stainless steel, wire-mesh cages suspended above cage boards.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: At least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18-26°C
- Humidity: 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: Deionized water
Details on dermal exposure:
TEST SITE
- Area of exposure: 37 square centimeters
- % coverage: Approximately 10% of the total body surface area
- Type of wrap if used: stretch gauze bandage and self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: Yes with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 1.0 mL
- For solids, paste formed: yes
Duration of exposure:
24 hours
Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for mortality and signs of illness, injury, and abnormal behaviour were made daily throughout the study. Observations for clinical signs of toxicity and dermal irritation were made daily throughout the study (weekends excluded for dermal irritation). The rats were weighed prior to treatment (test Day 0) and on test days 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
The rats exhibited no clinical signs of systemic toxicity during the study. One rat exhibited stained fur/skin on test days 1 and 2. This clinical sign is commonly seen in wrapped rats and therefore is not considered test substance related.
Body weight:
No biologically important body weight losses were observed.
Gross pathology:
No gross lesions were present in the rats at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 (Male/female): > 5000 mg/kg
Executive summary:

A single dose of the test substance was applied to the shaved, intact skin of 5 male and 5 female rats at a dose of 5000 mg/kg of body weight. The male group and female group were dosed a week apart. The application site was covered with a semi-occlusive dressing for 24 hours, after which the test substance was removed. The rats were observed for 14 days following application. The rats were necropsied to detect grossly observable evidence of organ or tissue damage or dysfunction at the end of the 15-day test period.

No deaths occurred. The rats exhibited no clinical signs of systemic toxicity or biologically important body weight loss. No dermal irritation was observed. No gross lesions were present in the rats at necropsy.

Under the conditions of this study, the skin absorption of the test substance was greater than 5000 mg/kg of body weight when applied to the skin of male and female rats for 24 hours.

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