2-(2-butoxyethoxy)ethyl methacrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-04-09 - 1999-07-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-butoxyethoxy)ethyl methacrylate

EC Number:

230-813-8

EC Name:

2-(2-butoxyethoxy)ethyl methacrylate

Cas Number:

7328-22-5

Molecular formula:

C12H22O4

IUPAC Name:

2-(2-butoxyethoxy)ethyl 2-methylprop-2-enoate

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Batch No. ELF ATO 1162A66
storage: in dark at room temperature
Expiry date: February 2000
Purity: 98.87 %

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

Single dose of 0.5 ml undiluted test substance

Duration of treatment / exposure:

4 hours

Observation period:

A single dose of 0.5 ml of the undiluted test substance was applied to the closely-clipped skin of one flank.
The test substance was held in contact with the skin by means of a semi-occlusive dressing.
Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing and then daily until the end of the
observation period (day 15) at the latest.

Number of animals:

3 male New Zealand white rabbits

Details on study design:

TEST SITE
- Area of exposure: no data
- Type of wrap if used: dry gauze pad

REMOVAL OF TEST SUBSTANCE

- Time after start of exposure: 4 hours exposure

SCORING SYSTEM: OECD 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 15 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 15 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 15

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applacable

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: mean score over 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritant / corrosive response data:

A very slight or well-defined erythema was noted in all animals from day 1 up to day 10 at the latest.
Dryness of the skin was recorded in all animals from day 2 up to day 9 or 15.
Mean scores over 24, 48 and 72 hours for each animal were 0.7, 1.7 and 1.7 for erythema and 0.0, 0.0 and 0.0 for oedema.

Any other information on results incl. tables

Individual cutaneous examinations and mean values of the scores recorded at each reading (24, 48 and 72 hours) for each animal

Rabbit number	Dermal irritation	Scores				Mean irritaton score (1)	Interpretation (+) (-)
		1h D1	24h D2	48h D3	72h D4
768	Erythema	1	1	1	0	0.7	(-)
	Oedema	0	0	0	0	0.0	(-)
	Other	*	S	S	S
769	Erythema	2	2	2	1	1.7	(-)
	Oedema	0	0	0	0	0.0	(-)
	Other	*	S	S	S
770	Erythema	2	2	2	1	1.7	(-)
	Oedema	0	0	0	0	0.0	(-)
	Other	*	S	S	S

(1)  mean of scores on days 2,3 and 4

h = hour

D = day

(+) = irritation acc. to E.E.C criteria

(-) = non- irritation acc. to E.E.C criteria

* = None

S = Dryness to skin

 

 

Table continued

Rabbit number	Dermal irritation	Scores
		D5	D6	D7	D8	D9	D10	D11	D12	D13	D14	D15
768	Erythema	0	0	0	0	0	0	-	-	-	-	-
	Oedema	0	0	0	0	0	0	-	-	-	-	-
	Other	S	S	S	S	S	*	-	-	-	-	-
769	Erythema	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0
	Other	S	S	S	S	S	S	S	S	S	S	S
770	Erythema	1	1	1	1	1	1	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0
	Other	S	S	S	S	S	S	S	S	S	S	S

D = day

* = None

S = Dryness to skin

- = Cutaneous examination not performed

 

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

In a skin irritation study acc. OECD 404 6 rabbits were dermally exposed to 0.5 ml Butyldiglycol methacrylate. Mean scores over 24, 48 and 72 hours for each animal were 0.7; 1.7 and 1.7 for erythema and 0.0; 0.0 and 0.0 for edema. The irritations were fully reversible within 15 days.
Butyldiglycol methacrylate is not classified acc. EU-GHS criteria.

Executive summary:

In a skin irritation study acc. OECD 404 3 New Zealnad White rabbits were dermally exposed to 0.5 ml Butyldiglycol methacrylate. Two application sites per animal were treated, one site was left intact, the other site was clipped. The test sites were covered with a semi-occlusive dressing for 4 hours. Animals were observed for 15 days. Mean scores over 24, 48 and 72 hours for each animal were 0.7; 1.7 and 1.7 for erythema and 0.0; 0.0 and 0.0 for edema. The irritations were fully reversible within 15 days.

Butyldiglycol methacrylate is not classified acc. EU-GHS criteria.

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