Butyl decanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04 - 18 Feb 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

no experimental 48 h reading performed, only 72 h observation period, 24 h occlusive application, analytical purity of test substance not specified, limited documentation available

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, 24 instead of 4 h exposure, no experimental 48 h reading performed, limited documentation, analytical purity of test substance not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: FHSA

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Butyl stearate

EC Number:

204-666-5

EC Name:

Butyl stearate

Cas Number:

123-95-5

Molecular formula:

C22H44O2

IUPAC Name:

butyl stearate

Details on test material:

- Name of test material (as cited in study report): butyl stearate, octadecanoic acid, butyl ester
- Analytical purity: no data

Test animals

Species:

rabbit

Strain:

other: Albino

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

unchanged (no vehicle)

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): undiluted

Duration of treatment / exposure:

24 hours

Observation period:

72 hours (as all signs of irritation were fully reversible)
Reading time points: 24 and 72 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: back skin, 2.5 cm x 2.5 cm
- Type of wrap if used: clear plastic trunk bands

SCORING SYSTEM: according to Draize

The animals were immobilized during the 24 hour exposure period.
Upon removal of the patches the resulting reactions were evaluated on the basis weighted scores. Evaluations were again made after 72 hours.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 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:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: 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)

Other effects:

The skin scores upon treatment of abraded skin were similar to intact skin.

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	0	0	1	0	0	0	0	0	0	0	1	0
48 h	No experimental data available; for calculation of mean scores, the 48 h values were assumed to bet he 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	0.00	0.00	0.67	0.00	0.00	0.00	0.00	0.00	0.00	0.00	0.67	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:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

CLP: not classified