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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
5th april 2006 - 18th april 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Test material form:
solid: particulate/powder
Details on test material:
Light pink tinted powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Provided by Syngenta, Batch number 4, Syngenta CTL number T12511/002
- Expiration date of the lot/batch: n/a
- Purity test date: not specified

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room tempareture in the dark
- Solubility and stability of the test substance in the solvent/vehicle: n/a, material moistened with distilled water, does not dissolve in water

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: moistened with distilled water
- Preliminary purification step (if any): n/a
- Final dilution of a dissolved solid, stock liquid or gel: n/a
- Final preparation of a solid: moistened with distilled water

FORM AS APPLIED IN THE TEST (if different from that of starting material) : paste

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: at last 200g, did not exceed +/- 20% of mean weight for each sex
- Fasting period before study: no
- Housing:housed in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): Certified rat and mouse diet (code 5LF2) supplied by BCM IPS Limitied, London, UK - routinely analysed and considered not to contain contaminants
- Water (e.g. ad libitum): Mains - routinely analysed and considered not to contain contaminants
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23
- Humidity (%): 30 to 87
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 hours continuous artificial light, 12 hours continuous dark. Controlled by a switch.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: Moistened with distilled water
Details on dermal exposure:
TEST SITE
- Area of exposure: back and flank
- % coverage: roughly 10%
- Type of wrap if used: a piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the 24 hour contact period, the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test material
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Concentration (if solution): n/a
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): moistened with distilled water to form paste
- Concentration (if solution): n/a
- Lot/batch no. (if required): n/a
- Purity:n/a
Duration of exposure:
24 hours
Doses:
1
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Once per day
- Necropsy of survivors performed: Yes
- Other examinations performed: Body weight recorded on days 0 (before application of test material), 7 and 14. Normal bodyweight gain observed over period, as expected.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
There were no deaths.

There were no signs of systemic toxicity.

All animals showed expected gains in bodyweight over the
study period.
Body weight:
Gained at expected levels
Gross pathology:
Effects on organs:
No abnormalities were noted at necropsy.
Other findings:
Signs of toxicity (local):
There were no signs of dermal irritation.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No signs of dermal irritation

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