Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996-03-11 to 1996-03-26

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

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:

Glyceryl Citrate/Lactate/Linoleate/Oleate

IUPAC Name:

Glyceryl Citrate/Lactate/Linoleate/Oleate

Constituent 2

Reference substance name:

Glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salts

EC Number:

294-585-1

EC Name:

Glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salts

Cas Number:

91744-23-9

IUPAC Name:

91744-23-9

Test material form:

liquid

Specific details on test material used for the study:

- Physical state: liquid
- Stability under test conditions: > 1 year

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Weight at study initiation: 3 - 4.4 kg
- Housing: Conventionally, singly in stainless steel cages
- Diet: Ssniff K 4- Complete feed for rabbits, supplied by Ssniff, Soest, Germany, ad libitum
- Water: Drinking water, supplied by Gelsenwasser, Wasserwerk, Haltern, Germany, ad libitum
- Acclimation period: At least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C
- Humidity: 30 - 70 %
- Air changes: 15 per hour
- Photoperiod: 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: an adjacent area of untreated skin

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: Undiluted

Duration of treatment / exposure:

4 hours

Observation period:

30-60 minutes, 24, 48 and 72 hours, 6, 8, and 14 days after patch removal

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: gauze patch covered with a non-irritant plaster and a semiocclusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD Guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.11

Max. score:

4

Reversibility:

fully reversible within: 14 days

Other effects:

The following effects were noted:
2-3 days: Slightly oedema
Day 8: Light brown discoloration and dryness of skin.
Day 10: Subsided irritations

Any other information on results incl. tables

Table: Irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
30 - 60 min	2/2/2	2/1/1
24 h	2/2/2	1/1/2
48 h	1/2/1	1/1/1
72 h	1/2/2	1/1/1
Average 24h, 48h, 72h	1.67	1.11
Reversibility*)	c.	c.
Average time (unit) for reversion	14 days	14 days

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met