Tri-C18-22 (even numbered)-alkyl 2-hydroxypropane-1,2,3-tricarboxylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

from 1998-09-14 to 1998-09-18

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Tri (hexyl, octyl, decyl) citrate

IUPAC Name:

Tri (hexyl, octyl, decyl) citrate

Constituent 2

Reference substance name:

2-Hydroxypropane-1,2,3-tricarboxylic acid, tri (hexyl, octyl, decyl) ester

IUPAC Name:

2-Hydroxypropane-1,2,3-tricarboxylic acid, tri (hexyl, octyl, decyl) ester

Constituent 3

Reference substance name:

-

EC Number:

430-290-8

EC Name:

-

IUPAC Name:

430-290-8

Details on test material:

- Name of test material (as cited in study report): Tri (hexyl, octyl, decyl) citrate
- Substance type: pure active substance
- Physical state: liquid
- Storage condition of test material: room temperature in a closed container

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kißleg, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.4 - 3.8 kg
- Housing: individually housed in ABS-plastic rabbit cages, floor 4200 cm²
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet for rabbits ad libitum
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 1998-09-14 To: 1998-09-18

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated other side served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

up to 72 hours after patch removal

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: approx. 6 cm² of shaved skin on one side of the dorsal area
- % coverage: not mentioned
- Type of wrap if used: gauze patch, which was held in place with non-irritating tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

No skin reactions (erythema, oedema) were recorded throughout the observation period of 72 hours as compared to untreated control sites.

Other effects:

There were no significant body weight changes during the contact and observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU