Registration Dossier

Administrative data

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:
other: Guideline study, GLP
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals 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:
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.

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:
other: Guideline study, GLP
Qualifier:
according to
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 opacity1

iritis1

redness2

chemosis2

 

 

Subcategory 2A

 

  • Reversible in 21 days

 

Subcategory 2B

 

  • Reversible in 7 days
Interpretation of results:
not irritating
Remarks:
Migrated information 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

Justification for selection of eye irritation endpoint:
Only one key study available;OECD 405, GLP

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.