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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Feb - May 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP / guideline study without deficiencies

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
d-Phenothrin
IUPAC Name:
d-Phenothrin
Constituent 2
Reference substance name:
Cyclopropanecarboxylic acid, 2,2-dimethyl-3-(2-methyl-1-propenyl)-, (3-phenoxyphenyl) methyl ester, (1R)
IUPAC Name:
Cyclopropanecarboxylic acid, 2,2-dimethyl-3-(2-methyl-1-propenyl)-, (3-phenoxyphenyl) methyl ester, (1R)
Constituent 3
Reference substance name:
188023-86-1
Cas Number:
188023-86-1
IUPAC Name:
188023-86-1
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): d-Phenothrin
- Physical state: yellow to brown transparent viscous liquid
- Purity test date: 25 August 2005
- Lot/batch No.: S5237276801
- Expiration date of the lot/batch: July 2008
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Animal Breeding Facility, JRF
- Age at study initiation: 10 - 11 weeks
- Weight at study initiation: m: 210 - 286 g, f: 202 - 220 g
- Fasting period before study: no
- Housing: individual, polypropylene cages, rice husk bedding
- Diet (e.g. ad libitum): rat pellet feed (Amrut brand) ad libitum
- Water (e.g. ad libitum): filtered water ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): 63 - 67
- Air changes (per hr): min. 15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 2006-03-31 To: 2006-04-14

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: not reported
- % coverage: 10
- Type of wrap if used: porous gauze dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): using cotton moistened with distilled water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: rats were observed for clinical signs and mortalities at 1, 2, 3, and 6 h post exposure. Subsequently, animals were observed twice per day for morbidity/mortality. Clinical signs were recoreded once per day. Animals were weighed prior to exposure, and on days 7 and 14 after application.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
not applicable for limit test

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
No clinical signs
Body weight:
No effect on body weight
Gross pathology:
No external or visceral abnormalities

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) of d-Phenothrin in Wistar rats was found to be greater than 2000 mg/kg body weight. Thus, the test substance is not classified for acute dermal toxicity according to the criteria of Regulation 1272/2008.
Executive summary:

This study was performed to assess the acute dermal toxicity of d-Phenothrin in Wistar rats. The method followed was as per the guidelines of OECD N° 402 (February 1987).

Two groups of rats, each comprising of 5 males and 5 females were randomly selected for the study. Approximately, 10 per cent of the body surface area was clipped 24 hours prior to the dermal application of the test substance. One group (group I) served as the control and was treated with distilled water. The other group (group II) was given a limit dose of 2000 mg d-Phenothrin/kg bw by dermal application and observed for a period of 14 days. No clinical symptoms or mortality were observed in the rats from either the control or the treatment group. All the rats, at the end of the observation period, were sacrificed and subjected to gross pathological examination. The rats sacrificed at termination belonging to the control as well as the treatment group did not reveal any lesion of pathological significance.

The acute dermal median lethal dose (LD50) of d-Phenothrin in Wistar rats was found to be greater than 2000 mg/kg body weight.