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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study following the guideline without any deviation but not performed under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
not specified
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
purity > 98%
batch number: A

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: élevage JANVIER, France
- Age at study initiation: 8 weeks
- Weight at study initiation: 188 to 206 g
- Fasting period before study: the day before the treatment
- Housing: 3 animals per polycarbonate cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): 15 volume per hour
- Photoperiod: 12 hrs dark/ 12 hrs light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: dose applied: 2000 mg/kg bw, corresponding to 2,32 mL/ kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 females for the first administration and then 3 other females for confirmation
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation for clinical signs and weighing at days 0, 2, 7 and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured during the study
Clinical signs:
no clinical signs detected
Body weight:
weight evolution remained normal during the test and observation period
Gross pathology:
only white thickening of the stomach mucosa was found in 3 female / 6
Other findings:
no other findings

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the test, a oral LD50 cutt off > 5000 mg/kg bw was considered for Phosphorous acid, tri-C12-14-alkyl esters.
Executive summary:

Phosphorous acid, tri-C12-14-alkyl esters was tested in a acute toxicity class method, according to OECD 423 test guideline and without any deviation. The study was considered as reliable but was not performed under GLP conditions and a reliability 2 was then associated.

Six female Sprague Dawley rats were given 2000 mg/kg bw test substance by gavage and no clinical sign nor behaviour comportment were found. No mortality occured even after 14 day observation period.

Phosphorous acid, tri-C12-14-alkyl esters was then considered as not harmful if swallowed and could be not classified for this endpoint, according to the GHS classification criteria.