ε-Caprolactone, oligomers, esters with acrylic acid and 2,2,2',2'-tetrakis (hydroxymethyl)-3,3'-oxydipropan-1-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 - 13 Aug 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

no 48 h reading time point

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 2015

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

ε-Caprolactone, oligomers, esters with acrylic acid and 2,2,2',2'-tetrakis (hydroxymethyl)-3,3'-oxydipropan-1-ol

EC Number:

500-276-7

EC Name:

ε-Caprolactone, oligomers, esters with acrylic acid and 2,2,2',2'-tetrakis (hydroxymethyl)-3,3'-oxydipropan-1-ol

Cas Number:

89800-10-2

Molecular formula:

{(C10H16O7).(C3H3O)b.[(C6H10O2)m.(C3H3O)a]} (i.e., UVCB substance)

IUPAC Name:

ε-Caprolactone, oligomers, esters with acrylic acid and 2,2,2',2'-tetrakis (hydroxymethyl)-3,3'-oxydipropan-1-ol

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Pemberley Rabbits, Cottenham, Cambridgeshire
- Age at study initiation: 11 - 14 weeks
- Weight at study initiation: 2.5 - 3.1 kg
- Housing: individual, in metal cages with perforated floors
- Diet: Grain Harvester 474 Special Rabbit Pellets, ad libitum
- Water: tap water, ad libitum
- Acclimation period: suitably acclimatised

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ~19
- Humidity (%): 30 - 70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

24 h

Observation period:

72 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: The treated skin was covered with a gauze pad (2.5 x 2.5 cm). The treatment sites were occluded with "Elastoplast" elastic adhesive dressing backed with "Sleek" plaster.

REMOVAL OF TEST SUBSTANCE
- Washing: The occlusive dressing and gauze pads were removed and the treatment sites wiped to remove any residual test substance
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS
24 and 72 h after application of the test substance

SCORING SYSTEM:
- Method of calculation: Erythema and edema scores (Draize scoring system) for the observation time points 24 and 72 h were added up (for intact and abraded skin) and divided through 24 (= primary irritation index).
The evaluation was done as follows:
0 : not irritating
> 0 - 2: mild irritant
> 2 - 5: moderate irritant
> 5 - 6: moderate to severe irritant
> 6: severe irritant

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0.11

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: intact skin

Remarks:

(48 h value set as described under "Any other information on results incl. tables")

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: intact skin

Remarks:

(48 h value set as described under "Any other information on results incl. tables")

Results 3

Irritation parameter:

primary dermal irritation index (PDII)

Remarks:

(including erythema and edema)

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 24/72 h

Score:

0.1

Max. score:

8

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: intact and abraded skin

Irritant / corrosive response data:

24 hour after removal of the test substance 1 female out of 6 animals showed very slight erythema, which was reversible at the 72 h reading time point.

Any other information on results incl. tables

Table 1: Dermal reactions on intact skin

Reading time point	Male				Female
	Rabbit 1		Rabbit 2		Rabbit 3		Rabbit 4		Rabbit 5		Rabbit 6
	E	O	E	O	E	O	E	O	E	O	E	O
24 h	0	0	0	0	0	0	1	0	0	0	0	0
48 h *	0	0	0	0	0	0	1	0	0	0	0	0
72h	0	0	0	0	0	0	0	0	0	0	0	0

* As there was no reading 48 h after test substance application, this value was chosen between the 24 and 72 h values based on a worst case decision. Then the erythema and edema scores could be calculated.

Table 2: Dermal reaction on abraded skin **

Reading time point	Male				Female
	Rabbit 1		Rabbit 2		Rabbit 3		Rabbit 4		Rabbit 5		Rabbit 6
	E	O	E	O	E	O	E	O	E	O	E	O
24 h	1	0	0	0	0	0	1	0	0	0	0	0
72h	0	0	0	0	0	0	0	0	0	0	0	0

** not used to calculate mean erythema/edema

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