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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
Study period:
15 December 2009 - 1 April 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:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
Fenitrothion TG (SMT, sumithion)
Brown liquid
Lot no.: 070502

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: ORIENTBIO, Korea
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 280.8-303.3 g (M); 224.8 - 247.9 g (F)
- Fasting period before study: No
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: One week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.2-22.4
- Humidity (%): 27.8-65.1
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 22 Dec 2009 To: 5 Jan 2010

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 5 x 6 cm
- Type of wrap if used: Gauze, plastic film

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 2000 mg/kg bw (undiluted)
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes, concurrent no treatment
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 30 minutes, 1, 2, 4 and 6 hours on the day of dosingand daily thereafter
- Frequency of weighing: Days 0, 1, 3, 7 and 14 (terminal)
- Necropsy of survivors performed: yes
Statistics:
None

Results and discussion

Preliminary study:
Not reported
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No deaths occurred
Clinical signs:
There were no signs of toxicity
Body weight:
Bodyweights and weight gain were unaffected by treatment
Gross pathology:
Necropsy did not reveal any effects of treatment
Other findings:
None

Any other information on results incl. tables

Summary of mortality

Dose level (mg/kg bw)

Number of rats

Mortality

0

5M / 5F

-

2000

5M / 5F

-

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 of fenitrothion was found to be >2000 mg/kg bw. Fenitrothion does not therefore require classification for acute dermal toxicity according to the CLP Criteria.
Executive summary:

The acute dermal toxicity of fenitrothion was investigated in a study in the rat, performed in compliance with OECD 402. Groups of rats were exposed to fenitrothion for 24 hours under occlusive conditions at dose levels of 0 (control) or 2000 mg/kg bw and observed for 14 days. There was no mortality in this study and no signs of systemic toxicity or local irritation. Bodyweights were unaffected by treatment and gross necropsy did not reveal any effects. The acute dermal LD50 of fenitrothion was therefore found to be >2000 mg/kg bw under the conditions of this study.  Fenitrothion does not therefore require classification for acute dermal toxicity according to the CLP Criteria.