Branched and linear octadecanoic acid, esters with glycerol oligomers

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 Oct - 1 Nov 2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

/ occlusive dressing used, 24 h exposure period, no experimental 72 h reading performed, evaluation of reversibility of effects not possible due to study termination 3 days after dosing no initial test, individual body weights at conclusion of test missing, no information on test substance

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

28 July 2015

Deviations:

yes

Remarks:

/ occlusive dressing used, 24 h exposure period, no experimental 72 h reading performed, evaluation of reversibility not possible

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

other: Japanese Ministry of Health and Welfare

Version / remarks:

not specified

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no information given
- Age at study initiation: about 3 months
- Weight at study initiation: approximately 2 kg
- Housing: individual in stainless steel cages
- Diet: Lab Diet Certified Rabbit Diet (#5322), 100 g/ day/ animal
- Water: ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3 - 23.9
- Photoperiod (hrs dark / hrs light): 12/ 12

IN-LIFE DATES: From: 30 Oct To: 1 Nov 2001

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Remarks:

in addition: abraded

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

24 h

Observation period:

3 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm²
- Type of wrap if used: The test material was introduced to the test site under a square surgical gauze pad (Johnson & Johnson gauze sponge), two single layers thick. The test article and gauze pad were then covered with a piece of Kendall Webril® pad and were then fixed in place with 3 inch of Dermicel® Hypo-allergenic cloth tape (Johnson & Johnson). The entire trunk of each animal was then encased in an impermeable occlusive plastic wrapping, fixed in place with a 3 inch Zonas® porous tape (Johnson & Johnson).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed with water and paper towels.
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS
24, 48 and 72 h after dosing (0, 24 and 48 h after patch removal)

SCORING SYSTEM: Draize scoring system
- Method of calculation: No 72 h data are available; for calculation of mean scores, the highest score was considered as 72 h score

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

male

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

other: evaluation not possible, no skin evaluation performed 72 h after patch removal

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

male

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

other: evaluation not possible, no skin evaluation performed 72 h after patch removal

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

female

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

other: evaluation not possible, no skin evaluation performed 72 h after patch removal

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

male

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

male

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

female

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

not fully reversible within: 48 h

Irritant / corrosive response data:

The exposure period of 24 h caused very slight to well defined erythema and very slight to slight edema on rabbit skin. Erythema were not fully reversible within 72 h after dosing, edema, however, were fully reversible within 48 or 72 h after dosing. As the observation period after removing of the patch is limited to 48 h the mean scores for 24, 48 and 72 h were calculated by including the respective highest grade as 72 h value in addition. mean erythema scores (24, 48 and 72 h) were calculated to be 1.0 or 2.0, respectively, and mean edema scores (24, 48 and 72 h) 0 or 0.7, respectively. Although the observation period of 48 h after patch removal is too short to allow a conclusive decision regarding reversibility, it is concluded that the described effects are not sufficient to consider Isooctadecanoic acid, ester with oxybis[propanediol] (CAS 73296-86-3) as irritating to the skin taking into consideration the severity of the effects observed in the individual animals.

Any other information on results incl. tables

Table 1: Results of skin irritation study (for hazard assessment, the results on intact skin are considered)

Observation time	Rabbit no
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
24	1	0	1	0	2	1
48	1	0	1	0	2	0
72	No experimental data available; for calculation of mean scores, the 72 h values were assumed to be equivalent to the highest score determined either at 24 or 48 h reading time point (worst case assumption)

Table 2: Calculation of mean scores (for hazard assessment, the results on intact skin are considered)

	Rabbit no
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
Mean value 24 + 48 + 72 h*	1	0	1	0	2	0.7

*No 72 h data are available: for calculation of mean scores, the 72 h values were assumed to be equivalent to the highest score determined either at 24 or 48 h reading time point (worst case assumption).

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