Santicizer P1400

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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:

test procedure in accordance with national standard methods

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute 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:

- Identity: Santicizer Platinum 1400
- Batch No.: RP-620
- Supplier: Ferro Corporation
- Description: Clear Yellow Liquid
- Specific Gravity: 1.05
- Sample Preparation: The test article was used as received

Specific details on test material used for the study:

Identity: Santicizer P-1400
Batch No: RP-620
Supplied by: Ferro Corporation
Data received: 09/19/2010
Storage: Room temperature and humidity
Description: Clear yellow liquid
Specific gravity: 1.05
Sample Preparation: The test article was used as received

TEST DATES:
Study Initiation: 08 November 2010
Experimental Start Date: 10 November 2010
Experimental Term Date: 24 November 2010
Draft Report Signed: 07 January 2011
FInal Report Signed: 03 March 2011

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Myrtle's Rabbitry Incorporated, Thompson Statio, TN
- Received on: 10/21/10
- Date of birdh: 07/20/10
- Weight at study initiation: 2.4-2.9 for males and 2.8-3.0 for females
- Housing: 1/cage in suspended cages
- Diet (e.g. ad libitum): PMI Rabbit Chow - daily
- Water (e.g. ad libitum): freely available
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): parameters deviated from protocol - no adverse effect on the study animals or the integrity of the study
- Humidity (%): parameters deviated from protocol - no 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 dark/12 hr light

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- Area of exposure: 10x15 cm
- % coverage: 10%
- Type of wrap if used: piece of porous dressing (semi occlusive)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water distillated
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

Single Dose of 2000 mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 4 hours post dosing and once daily until Day 14
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, toxicity, pharmacological effects, gross pathology

Statistics:

An estimate of the LD50 was made based on the mortality occurring during the study.

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 until the end of the study.

Clinical signs:

other: Few faces were observed in two males and one female was observed with soiling of the anogenital area on day 14. No other observation.

Gross pathology:

Necropsy did not reveal any treatment- related changes.

Other findings:

No further observations

Any other information on results incl. tables

Erythema was slight to well defined with very slight to slight edema at 24 hours and by day 14 there was no erythema or edema observed.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The acute dermal toxicity LD50 of the test material Santicizer Platinum P 1400 is greater than 2000 mg/kg bw.

Executive summary:

The test article Santicizer Platinum P1400 was applied dermally to five male and female rabbits. The test material was kept in contact with the scin for 24 hours (semi- occlusive patch). The test sites were scored for dermal irritation at 24 hours post dose and on day 14 using numerical Draize scoring code below. The skin was evaluated for ulceration, necrosis and tissue destruction. Mortality, body weights, toxicit, pharmacologic effects were recorded. The results of the study showed incidence of few faces in two males and one female with soiling of the angemital area on day 14. Erythema was slight to well denined with very slight to sligh edema at 24 hours and by day 14 no erytthema was observed. The body weights were normal as well as the necropsy results.

Based on the result of this study, the acute dermal toxicity LD50 of the test material Santicizer Platinum P 1400 is greater than 2000 mg/kg bw.