2-(2-butoxyethoxy)ethyl methacrylate

Endpoint summary

Description of key information

Skin irritation: not irritating;  OECD 404, GLP
Eye irritation: not irritating; OECD 405, GLP

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

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 %

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

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.

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

 

 

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.

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08.04.1999-29.06.1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Animals
Sex. species, strain: male New Zealand White rabbits.
Reason for this choice: species generally accepted by regulatory authorities for this type of study.
Breeder. Elevage Cunicole de Val de Sel1e, 80160 Prouzel, France.
Number of animals: 3
Identification: the animals were identified individually with a metal ear tag.
Weight: on the day of treatment, the animals had a mean body weight ± standard deviation of 2.7 ±0.2kg.
Acclimatization: at least 5 days before the beginning of the study.

Environmental conditions
The conditions in the animal room were set as follows:
· temperature: 18 ± 3°C
· relative humidity: 30 to 70%
. light/dark cycle: 12 hlI2 h
· ventilation: approximately 12 cycles/hour of filtered, non~recycled air.
The temperature and relative humidity were under continuous control and recording. The records were checked daily and filed. In addition to these daily checks, the housing conditions and corresponding instrumentation and equipment were verified and calibrated at regular intervals.
The animals were housed individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm).
Each cage was equipped with a food container and a water bottle.

Food and water
During the study. the animals had free access to 112 C pelleted diet (UAR. 91360 Villemoissonsur-Orge, France).
Each batch of food was analysed by the supplier for composition and contaminant levels.
The diet formula is presented in appendix 2.
Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum.
Bacteriological and chemical analyses of the water and diet, including the detection of possible contaminants (pesticides, heavy metals and nitrosamines), are perfonned regularly by external laboratories.
The results of these analyses are archived at err.
No contaminants were known to have been present in the diet, drinking water or bedding material at levels which may be expected to have interfered with or prejudiced the outcome of the study.

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1 ml

Observation period (in vivo):

Eyes were examined approximately 1 hour, 24, 48 and 72 hours after administration of the test substance

Number of animals or in vitro replicates:

3

Details on study design:

The study design was established according to available infonnation on the test substance and according to the OECD (No. 405) and EC (92169/EEC. 8.5) guidelines.
As possible irritant effects were anticipated, the test substance was administered to a single animal (No. 768) in the first instance.
Since the test substance was not severely irritant on this first animal, it was then evaluated on two other animals (Nos. 769 and 770).

Administration of the test substance
A single dose of 0.1 mt of the undiluted test substance was instilled into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball.
The lower and upper eyelids were held together for about one second to avoid any loss of test substance. The right eye, which remained untreated, served as control.
The eyes were not rinsed after administration of the test substance.

OCULAR EXAMINATIONS
The eyes were examined approximately 1 hour, 24, 48 and 72 hours after administration of the
test substance.
Following the OEeD and EC guidelines:
• when there was no evidence of irritation after 72 hours, the study was ended.
• when there was persistent ocular irritation after 72 hours, the observation period was extended
to a maximum of 21 days (until day 22) in order to detennine the progress of the lesions and
their reversibility.
• when severe irritant effects were observed, the animals were killed on humane grounds.
Any change in the animals'behaviour was noted.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.66

Max. score:

1

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.66

Max. score:

1

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.66

Max. score:

1

Reversibility:

fully reversible within: 72 h

Classification of eye irritation studies according GHS-criteria

 

Substance: Butyldiglycol methacrylate             BDGMA                               CAS: 7328-22-5

 

Internal No.: LITSU 12-0039

 

Date/Expert: 12-11-02/Am

 

Animal No.	Corneal opacity/Hornhauttrübung[Scores]			Mean Draize score	Reversibility [scores]		Hazard category
	after 24 h	after 48 h	after 72 h		in 7 days	in 21 days
1	0	0	0	0	n.d.	n.d.
2	0	0	0	0	n.d.	n.d.
3	0	0	0	0	n.d.	n.d.
							none
Animal No.	Iritis/Regenbogenhautentzündung[Scores]			Mean Draize score	Reversibility [scores]		Hazard category
	after 24 h	after 48 h	after 72 h		in 7 days	in 21 days
1	0	0	0	0	n.d.	n.d.
2	0	0	0	0	n.d.	n.d.
3	0	0	0	0	n.d.	n.d.
							none
Animal No.	Conjunctiva redness (erythem) /Bindehautrötung[Scores]			Mean Draize score	Reversibility [scores]		Hazard category
	after 24 h	after 48 h	after 72 h		in 7 days	in 21 days
1	1	0	0	0.33	n.d.	n.d.
2	1	1	0	0.66	n.d.	n.d.
3	1	0	0	0.33	n.d.	n.d.
							none
Animal No.	Conjunctiva chemosis /Bindehautödem[Scores]			Mean Draize score in 2 of 3 animals	Reversibility [scores]		Hazard category
	after 24 h	after 48 h	after 72 h		in 7 days	in 21 days
1	1	0	0	0.33	n.d.	n.d.
2	1	1	0	0.66	n.d.	n.d.
3	1	1	0	0.66	n.d.	n.d.
							none

 

 

Classification: Hazard Category

none

 

 

n.d. = no data

 

Classification Criteria for serious Eye Damage/Eye Irritation

 

Category 1

 

• Irreversible damage to cornea, iris, conjunctiva 21 days after exposure in at least one animal
• Mean Draize score in 2 of 3 animals:

     corneal opacity≥ 3

     iritis ≥ 1,5

 

 

Category 2

 

• Reversible adverse effects on cornea, iris, conjunctiva
• Mean Draize score in 2 of 3 animals:

corneal opacity≥1

iritis≥1

redness≥2

chemosis≥2

 

 

Subcategory 2A

 

• Reversible in 21 days

 

Subcategory 2B

 

• Reversible in 7 days

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

In an eye irritation study acc. OECD 405 3 rabbits were exposed to 0.1 ml Butyldiglycol methacrylate. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.33, 0.66 and 0.66 for chemosis, 0.33, 0.66 and 0.33 for redness of the conjunctiva, 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity.
The irritations were fully reversible within 72 hours.
Butyldiglycol is not classified acc. EU-GHS criteria.

Executive summary:

In an eye irritation study acc. OECD 405 3 rabbits were exposed to 0.1 ml Butyldiglycol methacrylate. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.33, 0.66 and 0.66 for chemosis, 0.33, 0.66 and 0.33 for redness of the conjunctiva, 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity. The irritations were fully reversible within 72 hours.

Butyldiglycol is not classified acc. EU-GHS criteria.

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Reliable (RL= 1), relevant and adequate data are available for the skin and eye irritation potential of BDGMA

Skin irritation

In a skin irritation study acc. OECD 404, three New Zealand White rabbits were exposed to 0.5 ml Butyldiglycol methacrylate by dermal application. 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.

 

Eye irritation

In an eye irritation study acc. OECD 405, three rabbits were exposed to 0.1 ml Butyldiglycol methacrylate. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.33, 0.66 and 0.66 for chemosis, 0.33, 0.66 and 0.33 for redness of the conjunctiva, 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity.The irritations were fully reversible within 72 hours.

Justification for selection of skin irritation / corrosion endpoint:
Only one key study available;OECD 404, GLP (Klimisch code: 1)

Justification for selection of eye irritation endpoint:
Only one key study available;OECD 405, GLP (Klimisch code: 1)

Justification for classification or non-classification

Based on the available data, BDGMA does not need to be classified for eye irritation or skin irritation according to regulation (EC) 1272/2008 or the former European directive on classification and labelling 67/548/EEC. Thus, no labelling is required.