Santicizer P1400

Eye irritation

Administrative data

Endpoint:

eye 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:

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 870.2400 (Acute Eye Irritation)

Deviations:

no

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 material name: Santicizer Platinum P1400
- Supplied by: Ferro Corporation
- Data Received: 08/19/10
- Storage: Room Temperature and humidity
- Description: Clear yello liquid
- Sample preparation: The test article was used as received

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Remarks:

1 female and 2 males

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Myrtle's Rabbitry, Inc. Thompsons, TN
- Date received: 10/21/10
- Date of birth: 07/20/10
- Weight at study initiation: 2.7 -2.8 kg
- Housing: 1/ cage in suspended cages
- Diet ( ad libitum): Fresh PMI Rabbit Chow - daily
- Water: ad libitum
- Acclimation period: five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): This parameter deviated from the standard protocol. This did not influence the study animals and the integrity of the study.
- Humidity (%): This parameter deviated from the standard protocol. This did not influence the study animals and the integrity of the study.
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): 12hr /12 hr

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

Single 0.1 mL dose into eye

Observation period (in vivo):

1, 24, 48, 72 hours

Duration of post- treatment incubation (in vitro):

Not applicable

Number of animals or in vitro replicates:

Three rabbits: 2 males and 1 female

Details on study design:

SCORING SYSTEM: see attachment
TOOL USED TO ASSESS SCORE: sodium fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

1 Female and 2 Males

Time point:

24/48/72 h

Score:

0

Max. score:

80

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

1 Female and 2 Males

Time point:

24/48/72 h

Score:

0

Max. score:

10

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

1 Female and 2 Males

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

1 Female and 2 Males

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Ocular finding
Treated eyes: There was no corneal opacity, iritis or conjunctival irritation at any observation period.
Control eyes: The control eyes appeared normal at all observation periods.

Other effects:

Systemic observation
There were no abnormal physical signs noted during the observation period.

Any other information on results incl. tables

Table 1. Ocular Findings, Systemic Observations, and Body Weights
Animal No. / Sex	Item	Tissue	Reading	1 hour	24 hours	48 hours	72 hours
H3811 / Male	A	Cornea	Opacity	0	0	0	0
	B		Area	0	0	0	0
		1. Total = (A x B) x 5		0	0	0	0
	C	Iris		0	0	0	0
		2. Total = (C x 5)		0	0	0	0
	D	Conjunctiva	Redness	0	0	0	0
	E		Chemosis	0	0	0	0
	F		Discharge	0	0	0	0
		3. Total = (D+E+F) x 2		0	0	0	0
		Total = 1+2+3		0	0	0	0
		Systemic Observations		A	A	A	A
		Sodium Fluorescein			0	N/A	N/A
		Pretest Body Weight: 2.7 Kg
H3812 / Male	A	Cornea	Opacity	0	0	0	0
	B		Area	0	0	0	0
		1. Total = (A x B) x 5		0	0	0	0
	C	Iris		0	0	0	0
		2. Total = (C x 5)		0	0	0	0
	D	Conjunctiva	Redness	0	0	0	0
	E		Chemosis	1	0	0	0
	F		Discharge	1	0	0	0
		3. Total = (D+E+F) x 2		4	0	0	0
		Total = 1+2+3		4	0	0	0
		Systemic Observations		A	A	A	A
		Sodium Fluorescein			0	N/A	N/A
		Pretest Body Weight: 2.7 Kg
H3837 / Female	A	Cornea	Opacity	0	0	0	0
	B		Area	0	0	0	0
		1. Total = (A x B) x 5		0	0	0	0
	C	Iris		0	0	0	0
		2. Total = (C x 5)		0	0	0	0
	D	Conjunctiva	Redness	0	0	0	0
	E		Chemosis	0	0	0	0
	F		Discharge	0	0	0	0
		3. Total = (D+E+F) x 2		0	0	0	0
		Total = 1+2+3		0	0	0	0
		Systemic Observations		A	A	A	A
		Sodium Fluorescein			0	N/A	N/A
		Pretest Body Weight: 2.8 Kg

A = Normal

The control eyes appeared normal at all observation points

Table 2. Mean scores (EU and GHS)
Time Points	24 hours	48 hours	72 hours	Mean
Animal Number / Sex	H3811 / Male
Corneal Opacity	0	0	0	0.0
Iritis	0	0	0	0.0
Conjunctival Redness	0	0	0	0.0
Conjunctival Edema (chemosis)	0	0	0	0.0
Animal Number / Sex	H3812 / Male
Corneal Opacity	0	0	0	0.0
Iritis	0	0	0	0.0
Conjunctival Redness	0	0	0	0.0
Conjunctival Edema (chemosis)	0	0	0	0.0
Animal Number / Sex	H3837 / Female
Corneal Opacity	0	0	0	0.0
Iritis	0	0	0	0.0
Conjunctival Redness	0	0	0	0.0
Conjunctival Edema (chemosis)	0	0	0	0.0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Not irritating

Conclusions:

Based on the lack of effects observed, It was determined that the test material Santicizer P1400 did not produce irritation to eyes and does not meet the criteria for classification as an ocular irritant under GHS or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Executive summary:

In a key EPA OPPTS Guideline 870.2400 study, the potential of the test material (Santicizer P1400) to cause ocular irritation or corrosion was evaluated after instillation into the rabbit eye. 0.1 mL of the test material was placed into the conjunctival sac of one eye of three healthy New Zealand White rabbits (1 female and 2 males) with the contralateral eye serving as control. Treated and control eyes were examined pretest and scored by the Draize technique at 1, 24, 48, and 72 hours post-exposure. Sodium fluorescein dye procedures were used at the 24 hour observation interval and animals were evaluated for mortality, toxicity, and pharmacological effects at each ocular observation point. Body weights were recorded pretest.

 

No abnormal physical signs were observed during the study period and no corneal opacity, iritis, or conjunctival irritation was observed at any observation point. In 1 animal at the 1 hour timepoint, chemosis (1) and discharge (1), without redness (0) was observed. However, this was fully reversible by 24 hours and not considered indicative of irritation by the test material. All control eyes appeared normal through the study period.

 

Based on the lack of effects observed, It was determined that the test material Santicizer P1400 did not produce irritation to eyes and does not meet the criteria for classification as an ocular irritant under GHS or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.