Registration Dossier

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

Constituent 1
Reference substance name:
Reaction mass of benzyl 1-(isobutyryloxy)-2,2,4-trimethylpentan-3-yl phthalate and benzyl 3-(isobutyryloxy)-2,2,4-trimethylpentyl phthalate
EC Number:
701-008-3
Molecular formula:
C27H34O6
IUPAC Name:
Reaction mass of benzyl 1-(isobutyryloxy)-2,2,4-trimethylpentan-3-yl phthalate and benzyl 3-(isobutyryloxy)-2,2,4-trimethylpentyl phthalate
Constituent 2
Chemical structure
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.