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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15.12.1995 to 26 .12 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: A GLP compliant study undertaken to a standard considered to be equivalent to international test guidelines for a primary skin irritation study.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
There is no explicit statement in the report that the study was undertaken in accordance with a specific guideline, although there is a reference to 'OECD 1992 test guideline 404'.
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich
EC Number:
271-090-9
EC Name:
1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich
Cas Number:
68515-48-0
IUPAC Name:
bis(7-methyloctyl) phthalate
Constituent 2
Reference substance name:
DINP
IUPAC Name:
DINP
Details on test material:
- Name of test material (as cited in study report): Di-isononyl phthalate
- Substance type: Technical material
- Physical state: Colourless liquid
- pH : 6 (determined by the laboratory)
- Stability under test conditions: No data
- Storage condition of test material: Room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HRP Inc.,Denver, PA, USA
- Age at study initiation: Approximately 13-14 weeks
- Weight at study initiation: 2.29 to 2.49 kg
- Housing:Single housing in suspended stainless steel and wire mesh cages with absorbent paper below.
- Diet (e.g. ad libitum): Fixed amount daily
- Water (e.g. ad libitum): Ad libitum
- Acclimation period:10 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 65-70°F
- Humidity (%): 40-60% RH
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light):Approximately 12 hours dark/12 hours light


IN-LIFE DATES: From: 21 December 1995 To:26 December 1995

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml per animal
- Concentration (if solution): Undiluted test material


Duration of treatment / exposure:
Four hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 1 inch X 1 inch
- Type of wrap if used: gauze patch held in place by non-irritating tape and a semi-occluded dressing, and protected by a neck collar during the exposure period.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped using peanut oil and paper towel
- Time after start of exposure: 4 hours


SCORING SYSTEM:Draize 1959

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.08
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
Very slight erythema (barely perceptible) (Grade 1) observed in one rabbit at the 6 hour examination and one different rabbit at the 24 hour examination. The scores for erythema and oedema were 'Grade 0' (No response) at all other occasions of examination.
Other effects:
There were no other effects of treatment.

Any other information on results incl. tables

Dermal reactions to treatment were confined to very slight erythema (barely perceptible) in single animals at the 1 or 24 hour examinations. Individual dermal scores are appended in the 'attached background information' window below.

1) The mean erythema and oedema scores for each time interval are:

1 hr

24 hr

48 hr

72 hr

Erythema

0.17

0.17

0.00

0.00

Oedema

0.00

0.00

0.00

0.00

Mean erythema and oedema scores for 24, 48 and 72 hours are: Erythema: 0.06 Oedema: 0.00 2)The primary irritation index, as calculated by the modified Draize method, is: 0.08

Applicant's summary and conclusion

Interpretation of results:
other: very mild skin irritant
Remarks:
Criteria used for interpretation of results: other: Draize method
Conclusions:
The test material is an extremely mild skin irritant to rabbits
Executive summary:

In a 72 hour primary skin irritation study, 6 rabbits (New Zealand White) were exposed to a 4 hour semi-occluded application of 0.5 ml of undiluted di-isononyl phthalate to 1x1 inch.of clipped doral skin, and the sites examined 1, 24, 48 and 72 hours after treatment. Irritation responses were confined to very slight erythema in single rabbits at the1or 24 hour examinations. The primary skin irritation index was 0.08, and the test material was considered to be an extremely mild skin irritant.

The study was considered suitable for classification, and satisfied the guideline requirements for rabbit primary skin irritation studies.