O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 October 2005 to 10 November 2005

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: JMAFF 12 Nouan 8147 (2000)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate

EC Number:

255-255-2

EC Name:

O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate

Cas Number:

41198-08-7

Molecular formula:

C11H15BrClO3PS

IUPAC Name:

4-bromo-2-chlorophenyl ethyl (propylsulfanyl)phosphonate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 hour exposure

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 animals/sex/gp

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

other: no deaths observed

Any other information on results incl. tables

Individual body weights and doses are presented in Table 1. Individual cage-side and necropsy observations are presented in Tables 2 and 3, respectively.

 

All animals survived, gained body weight, and appeared active and healthy during the study. Apart from dermal irritation (erythema and edema) noted at the dose site of four females between Days 1 and 2, there were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

 

Table 7.2.3-1: Individual bodyweights/weight gains and doses

Animal No.	Sex	Body Weight (g)					Dose# ml
		Day 0 Weight	Day 7 Weight	Gain*	Day 14 Weight	Gain*
6089	M	220	253	33	316	96	0.29
6090	M	241	261	20	338	97	0.32
6091	M	247	269	22	322	75	0.33
6092	M	243	273	30	356	113	0.33
6093	M	246	277	31	347	101	0.33
6094	F	190	211	21	236	46	0.25
6095	F	178	190	12	233	55	0.24
6096	F	191	204	13	241	50	0.26
6097	F	196	210	14	247	51	0.26
6098	F	189	207	18	242	53	0.25

* - Body weight gain from Day 0.

# -The test substance was administered as received. Specific Gravity – 1.487 g/ml. 

 

Table 7.2.3-2: Individual cage-side observations

Animal Number	Findings	Day of Occurrence
MALES 6089 – 6093	Active and healthy	0-14
FEMALES 6094, 6096, 6097	Active and healthy Erythema / oedema present at dose site	0-14 1-2
6095	Active and healthy	0-14
6098	Active and healthy Erythema / oedema present at dose site	10-14 1

 

Table 7.2.3-3: Individual necropsy observations

Animal Number	Tissue	Findings
MALES 6089 – 6093	All tissues and organs	No gross abnormalities
FEMALES 6094 - 6098	All tissues and organs	No gross abnormalities

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, the single dose acute dermal LD50 of Profenofos Technical is greater than 2000 mg/kg of body weight in male and female rats.

Executive summary:

An acute dermal toxicity test was conducted with rats to determine the potential for Profenofos Technical to produce toxicity from a single topical application.

 

Two thousand milligrams of the test substance per kilogram of body weight was applied to the skin of ten healthy rats for 24 hours. The animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14 days. Body weights were recorded prior to application and again on Days 7 and 14 (termination). Necropsies were performed on all animals at terminal sacrifice.

 

All animals survived, gained body weight and appeared active and healthy during the study. Apart from dermal irritation (erythema and edema) noted at the dose site of four females between Days 1 and 2, there were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

 

Under the conditions of this study, the single dose acute dermal LD₅₀ of Profenofos Technical is greater than 2000 mg/kg of body weight in male and female rats.