1-(3,5-Dichloro-4-fluoro-phenyl)-2,2,2-trifluoro-ethanone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-(3,5-dichloro-4-fluorophenyl)-2,2,2-trifluoroethan-1-one

EC Number:

829-719-5

Cas Number:

1190865-44-1

Molecular formula:

C8H2Cl2F4O

IUPAC Name:

1-(3,5-dichloro-4-fluorophenyl)-2,2,2-trifluoroethan-1-one

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Not reported

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Not reported

Duration of exposure:

24 hours

Doses:

1000 mg/kg bw

No. of animals per sex per dose:

Three

Control animals:

no

Details on study design:

Clinical signs and bodyweight development as well as signs of skin irritation were monitored during the study over a period of eight days. All animals were subjected to gross necropsy.

Results and discussion

Mortality:

There were no deaths.

Clinical signs:

other: No signs of systemic toxicity were noted.

Gross pathology:

No abnormalities were observed during necropsy.

Other findings:

Weak signs of dermal irritation noted were very slight erythema, glossy skin, small superficial scattered scabs and scab lifting to reveal glossy skin.

Any other information on results incl. tables

Table 1: Individual dermal reactions, as scored according to Draize system

Dose level mg/kg	Animal number and sex	Observation	Effects noted after initiation of exposure (days)
			1	2	3	4	5	6	7	8
1000	1-0 female	Erythema	1	1	0	1	1	1	1	0
		Oedema	0	0	0	0	0	0	0	0
		Other	0	0	G	GSs	GSs	Ss	Ss	Ss
	1-1 female	Erythema	1	1	1	1	1	1	0	0
		Oedema	0	0	0	0	0	0	0	0
		Other	0	0	GSs	GSs	GSs	GSs	GSs	GSs
	1-2 female	Erythema	1	1	1	1	1	1	0	0
		Oedema	0	0	0	0	0	0	0	0
		Other	0	0	Ss	Ss	Ss	Ss	Ss	SsSg
0 = no reaction; G = Glossy skin; Ss = Small superficial scattered scabs; Sg = Scab lifting to reveal glossy skin

Table 2: Individual bodyweights and bodyweight changes

Dose level mg/kg	Animal number and sex	Bodyweight (g) at day		Bodyweight change (g)
1000	1-0 female	212	216	4
	1-1 female	212	221	9
	1-2 female	208	216	8

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Based on the results of the study, the dermal LD50 in the rat was found to be greater than 1000 mg/kg bw.

Executive summary:

The acute dermal toxicity of the substance was tested on three female rats of the Wistar strain by applying the undiluted substance at a dose of 1000 mg/kg bw to the intact skin under semi-occlusion for a period of 24 hours. The study was not conducted under GLP, but followed the basic principles of the standard acute method as laid down in EU Method B.4. No deaths occured. No clinical symptoms or signs of systemic toxicity were observed following dermal exposure. No abnormalities were noted at necropsy of the animals that were killed at the end of the study. All animals were also gaining bodyweights as expected. Only weak signs of dermal irritation were observed. Based on the study it was estimated that the dermal LD50 value for the substance in the rat was greater than 1000 mg/kg bw.