Registration Dossier
Registration Dossier
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EC number: 219-774-8 | CAS number: 2528-39-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 - 28 Mar 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted in 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Slovenska Narodna Akreditacna Sluzba, Bratislava, Slovenska Republika
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Trihexyl phosphate
- EC Number:
- 219-774-8
- EC Name:
- Trihexyl phosphate
- Cas Number:
- 2528-39-4
- Molecular formula:
- C18H39O4P
- IUPAC Name:
- trihexyl phosphate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dobrá Voda, Slovak Republic
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 - 10 weeks
- Weight at study initiation: 172 - 195 g (step 1), 193 - 204 g (step 2)
- Fasting period before study: animals were fasted over-night prior to administration and after administration for further 3 - 4 h
- Housing: 3 animals per cage in plastic cages suspended on stainless steel racks on Lignocel S3/4 bedding (Lufa-ITL GmbH, Germany)
- Diet: laboratory food ssniff (Spezialdiäten GmbH, Germany) was offered at recommended doses each day approximately at the same time (analyses were performed)
- Water: tap water, ad libitum (analyses were performed)
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.09 ± 0.21
- Humidity (%): 54.33 ± 2.34
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: standard vehicle according to OECD TG 423
DOSAGE PREPARATION: The required amount of the test item (according to the body weight and dose) was mixed with vehicle (olive oil) shortly before administration
- Doses:
- 2000 mg/kg bw (step 1 and 2)
- No. of animals per sex per dose:
- 3 females per step (2 steps)
- Control animals:
- no
- Remarks:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed individually immediately after administration of the test item and 0.5, 1, 2 and 4 hours later. Each animal was inspected daily for the next 14 days. Observations included: changes in skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity, and behavioural pattern. Particular attention was given to potential neurologic endpoints such as tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Body weights were determined immediately prior to administration of the test item and weekly thereafter.
- Necropsy of survivors performed: yes
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- Animals displayed no signs of intoxication, change of health, nor any other adverse reaction.
- Body weight:
- Normal body weight gains were observed in all animals.
- Gross pathology:
- No macroscopic findings were observed in any animal.
Any other information on results incl. tables
Table 1: Absolute body weights and body weight gain
| Step | Animal No. | Starting dose (mg/kg bw) | Body weight (g) | Body weight gain (week 2 - Initial (g) | ||
| Initial | Week 1 | Week 2 | ||||
| 1 | 1 | 2000 | 179 | 203 | 220 | 41 |
| 2 | 195 | 198 | 202 | 7 | ||
| 3 | 172 | 188 | 203 | 31 | ||
| 2 | 4 | 193 | 194 | 201 | 8 | |
| 5 | 206 | 219 | 234 | 28 | ||
| 6 | 204 | 222 | 230 | 26 | ||
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- In this acute oral toxicity study a LD50 value > 2000 mg/kg bw in female rats was found.
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