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

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:

1996-03-11 to 1996-03-26

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study. Raed-across from analogue substance. For justification of read-across and for further details please refer to the read-across report.

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)

Deviations:

no

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:

91744-23-9

Cas Number:

91744-23-9

IUPAC Name:

91744-23-9

Details on test material:

- Substance type: product
- Physical state: liquid
- Stability under test conditions: > 1 year
- Storage condition of test material: at room temperatures in the dark
- Manufacture date: May 1995
- Lot/batch No.: 505024
- Expiration date of the lot/batch: not earlier than May 1996

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
- Age at study initiation: adult, no further details mentioned
- Weight at study initiation: 3 - 4.4 kg
- Housing: conventionally, singly in stainless steel cages
- Diet (e.g. ad libitum): Ssniff K 4- Complete feed for rabbits, supplied by Ssniff, Soest, Germany, ad libitum
- Water (e.g. ad libitum): Drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk, Haltern, Germany
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30 - 70
- 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: an adjacent area of untreated skin

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 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
- % coverage: not mentioned
- Type of wrap if used: gauze patch covered with a non-irritant plaster and a semiocclusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 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

Irritant / corrosive response data:

AVERAGE SCORE
- Erythema: 1.67
- Edema: 1.11

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:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance is slightly irritating but does not warrant classification according to CLP.

Executive summary:

Dermal irritation of the test substance (CAS 9174 4-23-9, Glyceryl Citrate/Lactate/Linoleate/Oleate) was investigated in a study according to OECD 404 and GLP. 0.5 g of the test substance were applied to the shaved skin of three New Zealand White rabbits (semi-occlusive coverage). Total exposure was 4 h. Thereafter, the test substance was removed using warm water.

Observations were made after 30-60 minutes, 24, 48, and 72 h, as well as 6, 8, and 14 days after patch removal. An adjacent area of untreated skin served as control.

Mean erythema and edema scores after 24, 48, and 72 h were 1.67 and 1.11, respectively. Both were fully reversible within 14 days.

Based on the results of this test the substance is slightly irritating but does not warrant classification according to CLP.