Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation / corrosion, 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 applied (occluded) to the skin of rabbits for 24 hours, and the skin was subsequently assessed for signs of irritation 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

Species:
rabbit
Strain:
other: Probably New Zealand white
Details on test animals or test system and environmental conditions:
no data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
no data
Duration of treatment / exposure:
24 hours
Observation period:
One week
Number of animals:
Two females and one male
Details on study design:
TEST SITE
- Type of wrap if used: "plastic strips" to retard evaporation and avoid contamination.
no further data


REMOVAL OF TEST SUBSTANCE
Test material removed after 24 hours, presumbaly by gentle washing but no details given.


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: 24 hours
Score:
ca. 0.6
Max. score:
8
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Barely perceptible redness was reported in two of the three rabbits examined 24-hours after removal of the test material, with an average maximum score of 0.6 out of a possible 8. No irritation was reported at the other time points (1, 48, 72, 120 and 168 hours after the end of exposure) with any of the three rabbits.

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
A 24-hour covered application of undiluted Santicizer 278 was not irritating to the intact skin of three rabbits.
Executive summary:

Undiluted Santicizer 278 was applied to the clipped, intact skin of one male and two female albino rabbits, covered with "plastic strips", and removed after 24 hours. The animals were subsequently assessed for signs of irritation during the 7-day observation period, and the data scored according to the method of Draize.

Barely perceptible redness was reported in two of the three rabbits examined 24-hours after removal of the test material, with an average maximum score of 0.6 out of a possible 8. No irritation was reported at the other time points in any of the three rabbits. The investigators classed the test material as non-irritating when applied (occluded) to the intact skin of male and female rabbits. Under EC CLP regulations, this study would indicate that Santicizer 278 is not irritating to the skin.

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