Sucrose, glycerol and propane-1,2-diol, reaction products with C16-18(even numbered) fatty acids

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: HLD protocol number P 2/152, revision 5. to meet the requirements of the US Food and Drug Administration as described in the "Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics" (1995).

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

The test item was topically applied under occlusive dressing to intact and abraded skin sites on the back of rabbits once only for a contact period of 24 hours.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Sucrose, glycerol and propane-1,2-diol, reaction products with C16-18(even numbered) fatty acids

Molecular formula:

Representative, generic structures are given in "structural formula" wherein R = H or fatty acid residue and R' = sucrose residue, glycerol residue, H or alkali. Additional citric acid resp. its salt is present.

IUPAC Name:

Sucrose, glycerol and propane-1,2-diol, reaction products with C16-18(even numbered) fatty acids

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: H. Fortkamp, D-4540 Lengerich
- Age at study initiation: between 11 and 17 weeks
- Weight at study initiation: between 2.78 and 3.38 kg
- Housing: single housing in steel grid floor cages
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23°C
- Humidity (%): 40 - 70 %
- Air changes (per hr):at least 10 air chamges per hour
- Photoperiod (hrs dark / hrs light): 12 /12 hours

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 25 % in water

TEST SITE: Intact and abraded skin

Duration of treatment / exposure:

24 hours

Observation period:

25 hours and 72 hours after treatment

Number of animals:

6 male rabbits

Details on study design:

TEST SITE
- Area of exposure: about 2.5 x 2.5 cm
- Type of wrap if used: unabraded and abraded skin sites were covered with gauze pads which were the occluded and secured using a strip of impermeable adhesive plastic dressing wrapped around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was wiped but not rinsed with a disposable paper towel


Reactions were scored according to the Draize scale.

SCORING SYSTEM:
Erythema and eschar formation:
- No erythema: 0
- Very slight erythema (barely perceptible): 1
- Well-defined erythema: 2
- Moderate to severe erythema: 3
- Severe erythema (deep redness): 4

Oedema formation:
- No oedema: 0
- Very slight oedema (barely perceptible): 1
- Slight oedema (edges of area well-defined by definite raising): 2
- Moderate oedema (raised approx. 1 mm): 3
- Severe oedema (raised more than 1 mm and extending beyond the area of exposure): 4

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 h

Score:

0.33

Max. score:

8

Reversibility:

fully reversible

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In this study, Grilloten PSE 141 G (25% in water). was established to be not irritating to the skin.

According to the criteria of OECD GHS, Regluation (EC) 1272/2008 and of DSD (Directive 67/548/EEC), and no classification and labelling is required.

Executive summary:

In a primary dermal irritation study 6 young adult New Zealand White rabbits were dermally exposed to 0.5 mL of Grilloten PSE 141 G (25 % in water) for 24 hours to 2.5 x 2.5 cm of body surface area. Animals then were observed for 72 hours. Irritation was scored by the method of Draize.

The study is comparable to a guideline study (OECD 404) with some minor deviations (exposure time 24 h, readings at 24 and 72 h), which do not influence the results of the study.

The test material produced minimal irritation in 3/6 rabbits at the intact sites of five rabbits and abraded site at the 24 hours reading. The reactions had ameliorated completely in all three rabbits by the 72 hours observation.

The test item is considered to be non-irritant.