Fenitrothion

Acute Toxicity: dermal

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

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

Test material information

Constituent 1

Reference substance name:

Fenitrothion

EC Number:

204-524-2

EC Name:

Fenitrothion

Cas Number:

122-14-5

Molecular formula:

C9H12NO5PS

IUPAC Name:

O,O-dimethyl O-3-methyl-4-nitrophenyl phosphorothioate

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 or test system 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:

other: There were no signs of toxicity

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.