Reaction mass of (R)-cyano(3-phenoxyphenyl)methyl rel-(1R,3R)-3-((1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl)-2,2-dimethylcyclopropanecarboxylate and (R)-cyano(3-phenoxyphenyl)methyl rel-(1S,3S)-3-((1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl)-2,2-dimethylcyclopropanecarboxylate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: GLP study similar to guideline but with distinct deviations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

five male and five female rats per dose group were used, no bodyweight measurement, no necropsy performed

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of (R)-cyano(3-phenoxyphenyl)methyl rel-(1R,3R)-3-((1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl)-2,2-dimethylcyclopropanecarboxylate and (R)-cyano(3-phenoxyphenyl)methyl rel-(1S,3S)-3-((1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl)-2,2-dimethylcyclopropanecarboxylate

EC Number:

932-389-6

Molecular formula:

C23H19ClF3NO3

IUPAC Name:

Reaction mass of (R)-cyano(3-phenoxyphenyl)methyl rel-(1R,3R)-3-((1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl)-2,2-dimethylcyclopropanecarboxylate and (R)-cyano(3-phenoxyphenyl)methyl rel-(1S,3S)-3-((1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl)-2,2-dimethylcyclopropanecarboxylate

Test animals

Species:

rat

Strain:

other: Alderley Park SPF-derived albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Animal Breeding Unit, ICI Ltd., Pharmaceuticals Division, Alderley Park, Macclesfield, Cheshire, UK
- Weight at study initiation: 119-220 g
- Fasting period before study: 16-20 h
- Housing: in stainless steel cages with a maximum of 5 animals per cage
- Diet (e.g. ad libitum): BP PCD pellets ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 50-60%
- Air changes (per hr): 24
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

polyethylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: dorso-lumbar region
- coverage: 75x50 mm
- Type of wrap if used: aluminium foil patch held in place by adhesive polyethylene tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with cotton-wool soaked in lukewarm water
- Time after start of exposure: 24h

TEST MATERIAL
- Concentration (if solution): 2 mL/kg bw (= 100%), 50% and 10%
- Constant volume used: yes

Duration of exposure:

24 h

Doses:

2 mL/kg bw (= 100%), 50% and 10%

No. of animals per sex per dose:

5 male and 5 female animals per dose group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 1 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 0% of mortality at 1000 mg/kg; 100% of mortality at 2mL/kg.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 200 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 0% of mortality at 200 mg/kg; 100% of mortality at 2mL/kg.

Mortality:

Cumulative mortality data are given in table 1.

Clinical signs:

other: Signs of toxicity included incontinence, scouring, dehydration, subdued behavior, curvature of the spine, unsteady gait, nervous appearance, piloerection, and increased vocalisation when handled. At 1000 mg/kg bw the clinical signs described above were o

Any other information on results incl. tables

Table 1: Cumulative mortality in male rats after dermal exposure to cyhalothrin.

Time after dosing	Dose [mg/kg bw] and cumulative mortality
	200	1000	2 mL
day 1	0/5	0/5	0/5
day 2	0/5	0/5	0/5
day 3	0/5	0/5	0/5
day 4	0/5	0/5	2/5
day 5	0/5	0/5	4/5
day 7	0/5	0/5	5/5
day 15	0/5	0/5	5/5

 

Table 2: Cumulative mortality in female rats after dermal exposure to cyhalothrin.

Time after dosing	Dose [mg/kg bw] and cumulative mortality
	200	1000	2 mL
day 1	0/5	0/5	0/5
day 2	0/5	0/5	0/5
day 3	0/5	2/5	0/5
day 4	0/5	2/5	1/5
day 5	0/5	2/5	3/5
day 7	0/5	2/5	5/5
day 15	0/5	2/5	5/5

Applicant's summary and conclusion

Conclusions:

It was not possible to estimate the LD50 (rat, dermal) of cyhalothrin. The value of LD50 must be in the range of LD0 -LD100, that means 1000 mg/kg bw -2mL/kg bw in male rats and 200 mg/kg bw -2mL/kg bw in female rats.

Executive summary:

Acute dermal toxicity of cyhalothrin to rats was determined in an in vivo test on male and female animals similar to OECD Guideline 402. Dose range was 200 mg/kg bw - 2mL/kg bw. GLP compliance was stated.

Clinical signs included incontinence, scouring, dehydration, subdued behavior, curvature of the spine, unsteady gait, nervous appearance, piloerection, and increased vocalisation when handled. No animal died in the 200 mg/kg bw dose group. In the 1000 mg/kg bw group, no male but two females died. All animals were found dead in the 2 mL/kg bw group; deaths occurred on days 4-7. It was not possible to estimate the LD50 (rat, dermal) of cyhalothrin. The value of LD50 must be in the range of LD0 -LD100, that means 1000 mg/kg bw -2mL/kg bw in male rats and 200 mg/kg bw -2mL/kg bw in female rats.