Santicizer P1400

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-08-11 to 2011-03-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

benzyl butyl cis-cyclohexane-1,2-dicarboxylate

Cas Number:

1931129-39-3

Molecular formula:

C19H26O4

IUPAC Name:

benzyl butyl cis-cyclohexane-1,2-dicarboxylate

Test material form:

other: clear yellow liquid

Details on test material:

- Name of test material (as cited in study report): Santicizer Platinum P1400
- Supplied by Ferro Corporation
- Data received: 08/09/10
- Storage: Room temperature and humidity
- Description: Clear yellow liquid
- Specific Gravity: 1.05
- Sample preparation: Used as received

Specific details on test material used for the study:

Identity: Santicizer Platinum P-1400
Batch:: RP-620
Supplier: Ferro Corporation
Date Received: 19 August 2010
Storage: Room temperature and humidity
Description: Clear yellow liquid
Specific gravity: 1.05
Sample Preparation: Used as received

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Boyertown, PA on 11/09/10
- Age at study initiation: Born on 09/14/10
- Weight at study initiation: 179-184 grams for males and 291-324 for females
- Fasting period before study: 16-20 hours prior dosing
- Housing: suspended wire cages
- Diet (e.g. ad libitum): Fresh PMI Rat Chow (Diet#5012) was freely available except for 16-20 hours prior dosing
- Water (e.g. ad libitum): freely available
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): parameters deviated from protocol - not adverse effect on the study animals or the integrity of the study
- Humidity (%): parameters deviated from protocol - not adverse effect on the study animals or the integrity of the study
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): 12 hr light/12 hr dark

TEST DATES:
Study initiation: 08 November 2010
Experimental Start Date: 17 November 2010
Experiment Term date: 06 December 2010
Draft Report Signed: 06 January 2011
Final Report Signed: 03 March 2011

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000 mg/kg
- The test article was used as received and the dose was based on the sample weight as calculated from the specific gravity.

Doses:

1 single dose: 2000 mg/kg

No. of animals per sex per dose:

3 males and 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: half hr, 1, 2, 3 hr post dose and once daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, toxicity and pharmacological effects

Statistics:

Not available

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived the 2000 mg/kg oral dose

Clinical signs:

other: No abnormal physical signs were observed during the treatment

Gross pathology:

No effects

Other findings:

No additional observations

Any other information on results incl. tables

Table 1. Body Weights and Dose Volume
Animal No.		Sex	Dose Volume (mL)	Body Weight (g)
				Day 0	Day 7	Day 14
1		Female	0.34	179	246	262
2		Female	0.34	180	238	265
3		Female	0.35	184	243	277
Mean				181	242	268
S.D.				2.6	4.0	7.9
#				3	3	3
4	Male		0.61	320	384	418
5	Male		0.62	324	399	437
6	Male		0.55	291	363	398
Mean				312	382	418
S.D.				18.0	18.1	19.5
#				3	3	3

Table 2. Necropsy Observations
Animal Number	1	2	3	4	5	6
Sex	Female	Female	Female	Male	Male	Male
Death (D) / Sacrifice (S)	S	S	S	S	S
Observation
Appeared normal / No findings	X	X	X	X	X	X

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Based on the results observed, the LD50 of the test material Santicizer Platinum P1400 was determined to be greater than 2000 mg/Kg body weight in rats.

Executive summary:

The potential for oral acute toxicity of the test material Santicizer Platinum P1400 was determined according the OECD 423 and OPPTS 870.1000 Testing Guidelines. Three males and three females Sprague Dawley were dosed orally with 2000 mg/Kg of Santicizer Platinum P1400. The single dose was based on the sample weight as calculated from the specific gravity. A single dose was administered orally by syringe and dosing needle.

The animals were observed for mortality, body weight changes, general toxicity and pharmacological effects. All animals survived until the end of the treatment. No abnormal physical signs nor changes in body weights related to the treatment were observed. The gross pathology were normal. Based on the results of this study, the LD₅₀ was considered to be greater than 2000 mg/Kg bw.