Santicizer 278®

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Remarks:

In vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Only available as a brief summary report

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The undiluted test material was placed in the conjunctival sac of the right eye of each of three rabbits, and the eyes were rinsed after 24 hours and assessed for signs of inflammation over a period of a week.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Reaction Mass of Benzyl (1R,1S) 2,2,4-trimethyl-1-[(2-methylpropanoyl)oxy]pentan-3-yl benzene-1,2-dicarboxylate and Benzyl (3R,3S) 2,2,4-trimethyl-3-[(2-methylpropanoyl)oxy]pentyl benzene-1,2-dicarboxylate

EC Number:

701-008-3

Molecular formula:

C27H34O6

IUPAC Name:

Reaction Mass of Benzyl (1R,1S) 2,2,4-trimethyl-1-[(2-methylpropanoyl)oxy]pentan-3-yl benzene-1,2-dicarboxylate and Benzyl (3R,3S) 2,2,4-trimethyl-3-[(2-methylpropanoyl)oxy]pentyl benzene-1,2-dicarboxylate

Constituent 2

Reference substance name:

Benzyl 3-isobutyryloxy-1-isopropyl-2,2-dimethylpropyl phthalate

EC Number:

240-920-1

EC Name:

Benzyl 3-isobutyryloxy-1-isopropyl-2,2-dimethylpropyl phthalate

Cas Number:

16883-83-3

Molecular formula:

C27H34O6

IUPAC Name:

Benzyl 2,2,4-trimethyl-1-[(2-methylpropanoyl)oxy]pentan-3-yl benzene-1,2-dicarboxylate

Details on test material:

Name of test material (as cited in study report): Santicizer 278
- Lot/batch No.: EL 9026
no further data

Test animals / tissue source

Species:

rabbit

Strain:

other: Probably New Zealand white

Details on test animals or tissues and environmental conditions:

no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

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

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

One week

Number of animals or in vitro replicates:

Two males and one female

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm isotonic saline solution
- Time after start of exposure: 24 hours


SCORING SYSTEM: According to the method of Draize et al. (1944).

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1 hour

Score:

ca. 4

Max. score:

110

Reversibility:

fully reversible within: 24 hours

Irritant / corrosive response data:

Immediately after rinsing, little or no discomfort was observed. At 10 minutes and 1 hour after rinsing, barely perceptible erythema and slight discharge was seen (but no oedema), with an average score of 4 out of a possible 110 when examined at 1 hour post exposure. Eyes were described as normal when examined 24, 48, 72, 120 and 168 hours after rinsing.

Other effects:

no data

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Slight eye irritation was seen shortly after undiluted Santicizer 278 was placed in the conjunctival sac of the right eye of each of three rabbits, and subsequently rinsed after 24 hours, although this had cleared 24 hours later.

Executive summary:

Undiluted Santicizer 278 (0.1 ml) was placed in the conjunctival sac of the right eye of three albino rabbits, and subsequently rinsed with warm saline after 24 hours. The treated eyes were assessed for signs of irritation during the 7-day observation period, and the data scored according to the method of Draize.

Immediately after rinsing, little or no discomfort was observed. However, at 10 minutes and 1 hour after rinsing, barely perceptible erythema and slight discharge was seen (but no oedema), with an average score of 4 out of a possible 110 when examined at 1 hour post exposure. Eyes were described as normal when examined 24, 48, 72, 120 and 168 hours after rinsing. The investigators classed the test material as a slight eye irritant in male and female rabbits. Under the EC CLP regulations, this study would indicate that Santicizer 278 is not irritating to the eyes.