Registration Dossier

Toxicological information

Skin irritation / corrosion

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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:
other: Guideline study, GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
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

Constituent 1
Chemical structure
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:
other: 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

Resultsopen allclose all
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
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
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 15
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applacable
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:
not classified
Remarks:
Migrated information 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 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 is not classified acc. EU-GHS criteria.

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