Reaction products of decanoic acid and lauric acid with glycerol and polyglycerol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-10-06 to 1992-10-09

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

May 12, 1981

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of decanoic acid and lauric acid with glycerol and polyglycerol

EC Number:

946-420-6

Molecular formula:

not applicable

IUPAC Name:

Reaction products of decanoic acid and lauric acid with glycerol and polyglycerol

Test material form:

liquid: viscous

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Housing: individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system
- Diet (e.g. ad libitum): ad libitum, Ssniff K-Haltung (Zuchtdiät für Kaninchen), Form: pellets, 1.0-1.5 cm long, 0.5 cm diameter, Ssniff Spezialdiäten GmbH, 4770 Soest/Westfalen
- Water (e.g. ad libitum): ad libitum, drinking water as for human consumption, System: drinking nipples

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12h light/ 12h dark cycles

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: adjacent area of untreated skin served as negative control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

30-60 min after removal of the semi-occlusive dressing and 24, 48 and 72 h after patch removal

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: ca. 6 cm²
- Type of wrap if used: Ypsiplast ® (Holthaus Medical), held by non-irritating tape Elastoplast ® (Beiersdorf AG, Hamburg) and Stülpa ® (P. Hartmann AG, Heidenheim-Brenz)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual sample was carefully washed off with water or an appropriate solvent
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) Day of exposure at 30-60 min after patch removal and 24, 48 and 72 h after patch removal

SCORING SYSTEM: according to OECD Test Guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Very slight erythema (grade 1) was observed in 2/3 animals up to 48 h after patch removal, which were fully reversible within 72 h.

Other effects:

No other effects observed

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

 

Score at time point / Reversibility	Erythema Max. score: 4	Edema Max. score: 4
30 – 60 min	1/0/1	0/0/0
24 h	1/0/1	0/0/0
48 h	1/0/1	0/0/0
72 h	0/0/0	0/0/0
Average 24h, 48h, 72h	0.67/0/0.67	0/0/0

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Polyglycerin caprinate was not irritating in thin in vivo skin irritation study in rabbit.

Executive summary:

In a in vivo dermal irritation study according to OECD Test Guideline 404 (1981), three New Zealand White rabbits were dermally exposed to 0.5 mL of Polyglycerin caprinate (> 95% a.i.) for 4 h to 6 cm² skin area.  Animals then were observed for 72 h.  Irritation was scored by the method of OECD Test Guideline 404.

During the observation period only slight erythema (grade 1) in two of the three animals occurred, the observed effects were reversible within 72 h after application. In this study, Polyglycerin caprinate is not a dermal irritant.