Fenamiphos

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 1980

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Fenamiphos

EC Number:

244-848-1

EC Name:

Fenamiphos

Cas Number:

22224-92-6

Molecular formula:

C13H22NO3PS

IUPAC Name:

{ethoxy[3-methyl-4-(methylsulfanyl)phenoxy]phosphoryl}(propan-2-yl)amine

Test material form:

solid: crystalline

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: lutrol, warm

Details on dermal exposure:

TEST MATERIAL
- Amount applied: 0.05 - 2 mL

Duration of exposure:

24 h

Doses:

- 25, 35, 40, 45, 50, 65, 75, 100, 125, 1000 mg/kg bw (males)
- 25, 50, 75, 100, 125, 1000 mg/kg bw (females)

No. of animals per sex per dose:

males: 5 animals/group at dose levels: 25 and 1000 mg/kg bw; 10 animals/group at dose levels 35, 40, 45, 50, 65, 100, 125 mg/kg bw; 20 animals at 75 mg/kg bw;
females: 5 animals/group at dose levels: 25 and 1000 mg/kg bw; 10 animals/group at dose levels 50, 75, 100, and 125 mg/kg bw

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

72 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

92 mg/kg bw

Based on:

test mat.

Mortality:

Mortalitiy occured in male animals at and above doses of 45 mg/kg bw and at and above 75 mg/kg bw in females (please refer to Table 1 "Any other information on results incl. tables").

Clinical signs:

other: other: The following clinical symptoms were seen in male and female rats: apathy, laboured breathing, tremor, abdominal position, salivation, red lacrimation and soft faeces. Symptoms appeared in males after 66 min and in females after 41 min of exposure;

Gross pathology:

not specified

Other findings:

not specified

Any other information on results incl. tables

Table 1: Results summary

Dose [mg/kg bw]	Toxicological results*
	male rats	female rats
25	0/5/5	0/5/5
35	0/10/10	-
40	0/10/10	-
45	1/10/10	-
50	3/10/10	0/10/10
65	4/10/10	-
75	11/20/20	2/10/10
100	8/10/10	6/10/10
125	9/10/10	9/10/10
1000	5/5/5	5/5/5
	LD50: 72 mg/kg bw	LD50: 92 mg/kg bw

* 1^st figure = number of dead animals / 2^nd figure = number of animals with clinical signs / 3^rd figure = number of animals in the group

Applicant's summary and conclusion

Interpretation of results:

Category 2 based on GHS criteria

Conclusions:

The test item is toxic to rats following dermal administration in a lipophilic vehicle. The dermal LD50 of the test item in rats was 72 – 92 mg/kg bw in males and females, respectively.

Executive summary:

In a acute dermal toxiciy study equivalent to OECD 402, the test item was dissolved, emulsified, suspended in Lutrol (warm) and applied under occlusive conditions to groups of non-fasted male and female rats for an exposure duration of 24 hours at dose levels of 25, 35, 40, 45, 50, 65, 75, 100, 125 and 1000 mg/kg bw. The treatment volume was 0.05 - 2 mL/kg bw. The recovery period was 14 days.

Mortalitiy occured in male animals at and above doses of 45 mg/kg bw and at and above 75 mg/kg bw in females. Clinical signs were observed in all animals and all dose levels (apathy, laboured breathing, tremor, abdominal position, salivation, red lacrimation and soft faeces).

It was concluded that the test item is toxic to rats following dermal administration in a lipophilic vehicle. The dermal LD50 of the test item in rats was 72 – 92 mg/kg bw in males and females, respectively.