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Administrative data

Description of key information

The submission substance was found to be non-toxic by both the oral and dermal routes of exposure duing OECD Guideline studies. A study to determine the inhalation toxicity of the substance has not been conducted due to it being considered scientifically unjustified.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 September 1995 and 3 October 1995
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.
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Date of inspection: 31/01/09 Date of signature: 16/03/94
Test type:
fixed dose procedure
Limit test:
yes
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: five to eight weeks- Weight at study initiation: males = 142 to 155 g, females = 129 to 140 g.- Fasting period before study: overnight fast immediately before dosing and for two hours after dosing- Housing: solid floor polypropylene cages- Diet: ad libitum- Water: ad libitum- Acclimation period: at least five daysENVIRONMENTAL CONDITIONS- Temperature (°C): 19 to 23°C- Humidity (%): 48 to 59%- Air changes (per hr): approximately 15 changes per hour- Photoperiod (hrs dark / hrs light): 12 hours continuous light followed by 12 hours continuous darkIN-LIFE DATES: From: Day 1 To: Day 14
Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE- Concentration in vehicle: not stated- Amount of vehicle (if gavage): 10 ml/kg - the volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.- Justification for choice of vehicle: - Lot/batch no. (if required): not stated- Purity: not statedMAXIMUM DOSE VOLUME APPLIED: 10 ml/kg - the volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.DOSAGE PREPARATION (if unusual): not applicableCLASS METHOD (if applicable)- Rationale for the selection of the starting dose: not applicable
Doses:
2000 mg/kg for range finding study and main study.
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days - Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded prior to dosing on Day 0 and on Days 7 and 14.- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight
Statistics:
Determination of LD50
Preliminary study:
There were no deaths or clinical signs of toxicity.
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 during the study.
Body weight:
All animals showed expected gain in bodyweight during the study.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
- Organ weights: not recorded- Histopathology: not determined- Potential target organs: none- Other observations: none

The acute oral median lethal dose (LD50) of the test material, PX-200, in the Sprague-Dawley CD strain rate was found to be greater than 2000 mg/kg bw.

Interpretation of results:
not classified
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The acute oral 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.
Executive summary:

The method followed that in the OECD Guidelines for Testing of Chemicals No. 401 "Acute Oral Toxicity" and Method B1 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material as a suspension in arachis oil B.P. at a dose level of 2000 mg/kg bw. The animals were observed for fourteen days after the day of dosing and were then killed and subjected to gross pathological examination.

there were no deaths. No signs of systemic toxicity were noted during the study. All animals showed expected gain in bodyweight during the study. No abnormalities were noted at necropsy.

The acute oral median lethal dose (LD50) of the test material, PX-200, in the Sprague-Dawley CD strain rate was found to be greater than 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
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.
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
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
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.
Preliminary study:
Not applicable.
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

A study was conducted to assess the acute oral toxicity of the submission substance in the Sprague-Dawley CD-strain rat. The method used followed OECD Guidelines for Testing of Chemicals No. 401 "Acute Oral Toxicity." Based on the results of the range finding study, a further group of 10 animals (five males, five females) were dosed once by oral gavage with 2000 mg/kg. At the end of the 14 -day observation period, animals were sacrificed and the LD50 was determined to be > 2000 mg/kg.

A study was conducted to determine the acute dermal toxicity of the submission substance in the Sprague-Dawley CD strain rat. The method used followed OECD Guidelines for Testing of Chemicals No. 402 "Acute Dermal Toxicity." A group of 10 animals (five males and five females) were given a single, 24 -hour semi-occluded dermal application to intact skin of 2000 mg/kg bodyweight. The animals were observed for 14 days after trteatment, then sacrificed for gross pathological examination. There were no deaths. No signs of systemic toxicity or skin irritation were observed during the study period. The acute dermal LD50 of the submission substance was determined to be >2000 mg/kg bodyweight.

Reliability.

The above studies have all been ranked reliability 1 according to the Klimish et al system. This ranking was deemed appropriate because the studies were conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.

Justification for classification or non-classification

The submission substance did not meet the criteria for classification as toxic by either the oral or dermal routes of exposure according the EU labelling regulations during the relevant studies.