Oxybispropanediol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26Jul 1994 - 29Jul1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test was conducted under GLP circumstances with minor deviations with current OECD guideline. The deviations do not influence the study results. Purity was not reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries, Testing guidelines for Toxicology Studies, 59 NohSan No. 4200, January 28 1985

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

No sequential test strategy; 6 instead of 3 animals used; no monitoring of systemic toxicity or body weight

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Diglycerine

IUPAC Name:

Diglycerine

Details on test material:

Sponsor's identification: Diglycerine 801
Batch number: 40302-3
Purity: not reported
Description: colourless viscous liquid
Storage conditions: 4°C in darkness

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.29-2.52 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum, STANRAB SQC Rabbit Diet, Special Diets Services Ltd., Witham, UK
- Water: ad libitum
- Acclimation period:≥ 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 65-83
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

:

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped on day before application

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5x2.5cm
- Type of wrap: gauze patch, secured with surgical adhesive tape (BLENDERM)

REMOVAL OF TEST SUBSTANCE
- Washing: swabbing with cotton wool in distilled water
- Time after start of exposure: 4 hours

SCORING SYSTEM: According to Draize, numerical scoring system as described in OECD guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours after removal

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 hous after removal

Score:

0

Max. score:

4

Irritant / corrosive response data:

No corrosion was observed.

Other effects:

Very slight oedema was noted at one treated skin site one hour after patch removal, all treated skin sites appeared normal at the 24-hour observation.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a skin irritation test according to OECD guidelines and GLP principles, 6 rabbits were exposed to diglycerol was found to be not irritating.

Executive summary:

In a skin irritation test according to OECD guidelines and GLP, 6 rabbits were exposed to diglycerol. Very slight oedema was noted at one treated skin site one hour after patch removal. All treated skin sites appeared normal at the 24-hour observation. The test substance was found to be not irritating.