Glycerides, C8-10 mono- and di-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

7 Jun - 10 Jun 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study with acceptable restrictions. Purity of test substance is not specified.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Deviations:

yes

Remarks:

purity of test substance not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, mixed decanoyl and octanoyl

EC Number:

277-452-2

EC Name:

Glycerides, mixed decanoyl and octanoyl

Cas Number:

73398-61-5

Molecular formula:

C27H50O6 to C33H62O6

IUPAC Name:

Glycerides, mixed decanoyl and octanoyl

Details on test material:

- Name of test material: only trade name given
- Physical state: pale straw-coloured clear liquid
- Analytical purity: no data
- Storage conditions: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.24-2.42 kg
- Housing: individually in suspended metal cages
- Diet: rabbit diet (Preston Farmers Ltd., Lincolnshire, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-20
- Humidity (%): 64-68
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated sites of the same animals served as control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

72 h
Reading time points: 24, 48 and 72 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm gauze patch on the back of each rabbit
- Type of wrap if used: the treated skin was covered with surgical adhesive tape (BLENDERM), the trunk of rabbits was wrapped in an elasticated corset (TUBIGRIP).

REMOVAL OF TEST SUBSTANCE
- Washing: residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of all 6 animals

Time point:

other: mean after 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversiblity: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all 6 animals

Time point:

other: mean after 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

No skin reactions were observed during the study period in any animal.

Other effects:

No other local or systemic effects were observed in the study.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified