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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
20 March 2009 to 15 June 2009
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Studies undertaken to Chinese guidelines without GLP accreditation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Test Method for Chemicals, State Environmental Protection Administration, (China), May 2004, Guidelines for the Hazard Evaluation of New Chemical Substance (HJ/T 154-2004)
Deviations:
not specified
Principles of method if other than guideline:
Test Method: one-time maximization testing method was adopted according to relevant materials, and the dosage was 2500 mg/kg bw. 10 animal subjects were selected, female and male fifty-fifty. Hairs on their back were removed 24 hours before the test, and the unhairing area was 40 cm2. After 24 hours, no injuries were found on the unhaired skin, which was then contaminated. The test substance was diluted with peanut oil into a concentration of 748.03mg/ml, and then shaken up before sampling. The contaminated part was covered by two layers of gauze and fixed by non-irritating adhesive plaster after contamination. The residual was rinsed with soapy water and clear water after 24 hours. Toxic symptoms and death count of the animal subjects were observed and recorded within two weeks.
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Reference substance name:
P-Phenyl- Zinc Phosphate
IUPAC Name:
P-Phenyl- Zinc Phosphate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): P-Phenyl- Zinc Phosphate
- Substance type: Inorganic
- Physical state: Powder
- Analytical purity: No data
- Purity test date: no data
- Lot/batch No.: No data
- Expiration date of the lot/batch: No data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Commercial laboratory animal supplier
- Age at study initiation: No data
- Weight at study initiation: 180 to 220 g
- Fasting period before study: No data
- Housing:
- Diet: feedstuff was provided by Beijing Keao Xieli Feedstuff Co., Ltd.
- Water: no data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 25°C
- Humidity: 40 to 70%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
peanut oil
Details on dermal exposure:
TEST SITE
- Area of exposure: 40 cm2
- Type of wrap if used: two layers of gauze and fixed by non-irritating adhesive plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution): 748.03 mg/ml
- For solids, paste formed: no

VEHICLE
- Amount(s) applied (volume or weight with unit): No data
- Concentration (if solution): 748.03 mg/ml
Duration of exposure:
24 hours
Doses:
2500 mg/kg bw
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 and weighing: Weighed at 0, 7 and 14 days
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:
None
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None
Body weight:
Male 0 days 206.0 ± 3.4g 7 days 229.2 ± 5.6g 14 days 249.2 ± 8.5g
Female 0 days 209.0 ± 3.8g 7 days 222.6 ± 5.9g 14 days 235.2 ± 2.8g
Gross pathology:
None
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In light of grading standard of acute dermal toxicity test of Guidelines for the Hazard Evaluation of New Chemical Substance, (China), the acute dermal toxicity test on the rat gives a result of non-toxic.

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