Santicizer P1400

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Remarks:

In vivo study

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

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Principles of method if other than guideline:

Deviations of temperature and humidity (for several days during the study) were deemed to have had no adverse effects on the study animals or the integrity of the study, since all the animals gained weight normally, and were free from signs of stress based on daily observations.

GLP compliance:

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:

- Test article: Santicizer Platinum P 1400
- Batch No.: RP 620
- Supplied by: Ferro Corporation
- Date received: 08/09/10
- Storage: Roon temperature and humidity
- Description: Clear yellow liquid
- Sample preparation

Specific details on test material used for the study:

Label Identity: Santicizer P-1400
Batch No: RP-620
Supplied by: Ferro Corporation
Data received: 08/19/2010
Storage: Room temperature and humidity
Description: Clear yellow liquid
Sample preparation: Te test article was used as received

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Myrtle Rabbitry Inc., Thompson Station, TN
- Received on: 10/21/10
- Date of birth: 07/20/10
{Age at study initiation 3 months 21 days - study initiation date mm/dd 11/09/2010}
- Weight at study initiation: 2.7 -3.0 kg
- Housing: suspended wire bottom cages
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet #5321) - daily
- Water (e.g. ad libitum): freeily available
- Acclimation period: (>5 days) - approx 3 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C):[ Room temperature]. Parameters deviated from the protocol for several days during the study;
- Humidity (%): Parameters deviated from the protocol for several days during the study - Deviations of temperature and humidity were deemed to have had no adverse effects on the study animals or the integrity of the study, since all the animals gained weight normally, and were free from signs of stress based on daily observations.
- Air changes (per hr): no info
- Photoperiod: 12 hr light/12 hr dark
Fresh PMI rabbit chow was priovided daily (diet #5321) and drinking water was available ad-lib. The animal room was kept clean and vermin-free.
IN-LIFE DATES:
Study initiation: 11/08/2010
Experimental start due: 11/09/2010
Experimental term data: 11/12/2010
Draft report signed: 01/07/2011
Final report signed: 03/03/2011

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml/site applied to a 2x3 cm gauze patch.

Duration of treatment / exposure:

4 hours

Observation period:

60 minutes, 24, 48, 72 hours post patch removal

Number of animals:

3 male rabbits

Details on study design:

TEST SITE
- Area of exposure: 10x10
- % coverage: 3x3 cm
- Type of wrap if used: porous, not irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): ethanol (end of exposure time) prior scoring

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

Dermal observations:
Well defined erythema and very slight edema was observed at 1 hour following the 4 hour exposure. At 24 and 48 hours, absent to very slight erythema and very slight edema was observed. No erythema or edema was observed at 72 hours.

Systemic Observations and Body Weights:
There were no abnormal physical signs noted during the observation period

Other effects:

Systemic Observations and Body Weights:
There were no abnormal physical signs noted during the observation period. All body weight changes were normal.

Any other information on results incl. tables

Table1. Dermal Observations, Body Weights, and Systemic Observations
Rabbit Eartag	Animal Number
	H3798	H3799	H3800
Sex	Male	Male	Male
Pre-test Body Weight (Kg)	2.7	2.9	3.0
Terminal Body Weight (Kg)	2.7	2.9	3.0
Erythema and Eschar Formation
Time after Patch Removal
60 minutes	2	2	2
24 hours	0	1	1
48 hours	0	0	1
72 hours	0	0	0
Edema
60 minutes	1	1	1
24 hours	1	1	1
48 hours	1	1	1
72 hours	0	0	0
Systemic Observations
60 minutes	A	A	A
24 hours	A	A	A
48 hours	A	A	A
72 hours	A	A	A

A = Normal

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Not classified

Conclusions:

The test material Santiciser P1400 is a mild dermal irritant under the conditions of the study but does not meet the criteria for classification under EU CLP or GHS.

Executive summary:

The test material Santicizer Platinum P1400 was investigated to determine the irritant and corrosive effects when applied dermally for 4 hours. Three New Zealand rabbits were dosed dermally with 0.5 ml of the test material, which was applied and kept in contact to one skin site for 4 hours, at which time the wrapping was removed. The skin was evaluated for edema, erythema and scored at 1, 24, 48 and 72 hr (numerical Draize technique) following the patch removal. Toxicological and pharmacological effects, body weight and mortality were also recorded.

The results of the study showed well defined erythema and very slight edema at 1hr after the 4 hour exposure. At 24 and 48 hours, slight erythema and very slight edema was observed. These effects were fully reversible in all 3 tested animals by 72 hours. No adverse clinical signs, abnormal body weight or mortality were observed during the study. In conclusion, the test material Santiciser P1400 is a mild dermal irritant but does not meet the criteria for classification under EU CLP or GHS.