Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From August 03, 2016 to August 31, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
from the maxumum level of daily mean relative humidity; but no effects on the study integrity.
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
from the maxumum level of daily mean relative humidity; but no effects on the study integrity.
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Phosphoric acid, mono- and bis (C16-20 branched and linear alkyl) esters
- Batch: CH 200529/001
- Composition: UVCB
- Appearance: Lightly yellow liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
Source: Charles River Deutschland, Sulzfeld, Germany
Age: approx. 8 weeks old
Acclimatization period: at least 5 days before start of treatment
Temperature and relative humidity: 18 to 24°C and 40 to 70%, respectively.
Light period cycle: 12-hour light/12-hour dark
Diet and water: pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) and tap water, ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
- Method: oral gavage (plastic feeding tubes)
- Fasting: animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available ad libitum.
- Administration. Frequency: single dosage on Day 1. Dose level (volume): 2000 mg/kg (2.15 mL/kg) bw. Dose volume calculated as dose level (g/kg) / density (g/mL).
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
The test substance was administered by oral gavage to two consecutive groups of three female Wistar rats at 2000 mg/kg bw. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15). (The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups).
Statistics:
No statistical analysis was performed (the method used is not intended to allow the calculation of a precise LD50 value).

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality occurred
Clinical signs:
Hunched posture and/or piloerection were noted for three animals on Day 1 only
Body weight:
The mean body weight gain shown by the animals over the study period was considered to be normal
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals

Any other information on results incl. tables

The oral LD50 (rats) was established to exceed 2000 mg/kg bw. According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg bw. Based on these results, the test substance does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Remarks:
not classified
Conclusions:
Under the study conditions, the oral LD50 value of the test substance in Wistar rats was considered to exceed 2000 mg/kg bw.
Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance according to OECD guideline 423 and EPA OPPTS 870.1100 (acute toxic class method), in compliance with GLP. The test substance was administered by gavage to two consecutive groups of three female Wistar rats at a concentration of 2000 mg/kg bw. Animals were subjected to daily observations and weekly determinations of body weight. Macroscopic examination was performed after terminal sacrifice on Day 15. No mortality occurred. Hunched posture and/or piloerection were noted for three animals on Day 1 only. The mean body weight gain over the study period was considered to be normal. Finally, no abnormalities were found at macroscopic post mortem examination. Under the study conditions, the rat oral LD50 for the test substance was considered to exceed 2000 mg/kg bw (van Huygevoort, 2016).