Fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions. Occlusive dressing according to former guideline, only 40% solution applied, no experimental 48 h reading performed.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

occlusive dressing according to former guideline, only 40% solution applied, no experimental 48 h reading performed

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Journal Officiel de la Republique Francaise of 21/4/71 and 5/6/73

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18, esters with ethylene glycol

EC Number:

292-932-1

EC Name:

Fatty acids, C16-18, esters with ethylene glycol

Cas Number:

91031-31-1

IUPAC Name:

91031-31-1

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Analytical purity: no data

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: individually housed in cages or restraining devices which allow the back of the animals to be treated
- Diet: 200 g/day/animal in the form of granules (Granules Lapin Entretien SANDERS)
- Water: ad libitum
- Vaccination: myxomatosis and pasteurellosis

ENVIRONMENTAL CONDITIONS
- air-conditioned

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

other: olive oil

Controls:

other: not required, untreated sites of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 40% (v/v)

Duration of treatment / exposure:

24 h

Observation period:

72 h
Reading time points: 24 and 72 h

Number of animals:

6 males

Details on study design:

TEST SITE
- Area of exposure: left flank and right flank (scarified); shaved: 14 cm x 14 cm, patch size: 2 cm x 2 cm
- Type of wrap if used: The treated skin was covered with gauze, held in place with a "NEDDERMOTEST ROC"-patch, and an adhesive tape.

SCORING SYSTEM: Primary irritation index

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24 and 72 h

Score:

0.22

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)

Irritant / corrosive response data:

Intact skin:
2/6 animals showed slight erythema after 24 h which were fully reversible within 72 h.
Abraded skin:
In 5/6 slight irritating effects were observed after 24 h being fully reversible within 72 h.

No edema formation was apparent in any animal during the study period.

Other effects:

No other local or sytemic effects were reported.

Any other information on results incl. tables

Table 1. Results of skin irritation study. 

Observation time	Rabbit no.
	1		2		3		4		5		6
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
24 h	1	0	0	0	0	0	1	0	0	0	0	0
48 h	No experimental data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)
72 h	0	0	0	0	0	0	0	0	0	0	0	0

 

Table 2. Calculation of mean scores.

	Rabbit no.
	1		2		3		4		5		6
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
Mean value 24 + 48 + 72 h*	0,67	0,00	0,00	0,00	0,00	0,00	0,67	0,00	0,00	0,00	0,00	0,00

*No 48 h data are available: for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h).

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified