Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 Aug and 7 Sept 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
UK GLP standards (Schedule 1, Good Laboratory Practice Regulations 1997 (SI 1997/654)).
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): PX-200- Molecular formula (if other than submission substance): same as submission substance- Molecular weight (if other than submission substance): same as submission substance- Smiles notation (if other than submission substance): same as submission substance- InChl (if other than submission substance): same as submission substance- Structural formula attached as image file (if other than submission substance): same as submission substance- Substance type: white powder- Physical state: solid- Analytical purity: not stated- Impurities (identity and concentrations): not stated- Composition of test material, percentage of components: not stated- Isomers composition: not stated- Purity test date: not stated- Lot/batch No.:F10303- Expiration date of the lot/batch: not stated- Radiochemical purity (if radiolabelling): not stated- Specific activity (if radiolabelling): not stated- Locations of the label (if radiolabelling): not stated- Expiration date of radiochemical substance (if radiolabelling): not stated- Stability under test conditions: not stated- Storage condition of test material: room temperature- Other: not stated- Storage condition of test material: - Other:

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Charles River (UK) Ltd., Margate, Kent, UK.- Age at study initiation: Approximately 8 to 12 weeks.- Weight at study initiation: Males = 205 to 223 gm, Females = 204 to 212 gm.- Fasting period before study: No.- Housing: Suspended polypropylene cages furnished with wood flakes.- Diet: ad libitum- Water: ad libitum- Acclimation period: minimum period of five days.ENVIRONMENTAL CONDITIONS- Temperature (°C): 19 to 25°C- Humidity (%): 30 to 70%- Air changes (per hr): 15 changes per hour.- Photoperiod (hrs dark / hrs light): 12 hours continuos light, followed by 12 hours continuous darkIN-LIFE DATES: From: Day 1 To: Day 14

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
arachis oil
Details on dermal exposure:
TEST SITE- Area of exposure: Back and flanks- % coverage: 10%- Type of wrap if used: Surgical gauze with a self adhesive bandage. REMOVAL OF TEST SUBSTANCE- Washing (if done): Arachis Oil BP used to remove any residual test material.- Time after start of exposure: 4 hoursTEST MATERIAL- Amount(s) applied (volume or weight with unit): Exact amount not stated in report. - Concentration (if solution): Not applicable.- Constant volume or concentration used: Yes- For solids, paste formed: Not stated in report. Was moistened with Arachis Oil BP.VEHICLE- Amount(s) applied (volume or weight with unit):Not stated in report.- Concentration (if solution): Not stated in report.- Lot/batch no. (if required): Not stated in report.- Purity: Not stated in report.
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males / 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days - Frequency of observations and weighing: Observed for deaths or overt signs of toxicity at 0.5 hrs, 1, 2 and 4 hours after dosing, and subsequently once daily for 14 days.- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight, histopathology, other: dermal reactions
Statistics:
Not applicable.

Results and discussion

Preliminary study:
Not applicable.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths.
Clinical signs:
No signs of systemic toxicity were noted.
Body weight:
All animals showed an expected gain in bodyweight during the study.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
- Organ weights: Not recorded.- Histopathology: Not recorded.- Potential target organs: None.- Other observations: None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) of the test material, PX-200, in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg/bw. No symbol and risk phrases are required according to EU labelling regulations.
Executive summary:

A study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley CD strain rat. the method used followed that described in the OECD Guidelines for Testing of Chemicals No. 402 "Acute Dermal Toxicity" (adopted 24 February 1987) and Method B3 of Commission directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

The acute dermal median lethal dose (LD50) of the test material, PX-200, in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg/bw. No symbol and risk phrases are required according to EU labelling regulations.