Registration Dossier

Skin irritation:

- not irritating in rabbits (OECD TG 404; GLP; RL1); undiluted test material applied to the intact skin of 3 animals for 4 hours; slight to moderate edema 3/3 animals, grade 1 edema still present after 8 d (end of observation period); as a tendency toward reversibility was noted, it is judged to be reversible

Eye irritation:

- not irritating in rabbits (OECD TG 405; GLP; RL1); undiluted test material applied to right eye of 3 animal, rinsed after 24 h; grade 1 conjunctival redness (1/3 animals after 1 h), grade 1 discharge (2/3 animals after 1 h)

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

Adopted 21 May 81

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, D-4932 Extertal
- Age at study initiation: 10 weeks
- Housing: individually
- Diet (e.g. ad libitum): conventional Iaboratory diet (mümmel z, ssniff/Soest), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2°C
- Humidity (%): 40 -50%
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: adjacent areas of untreated skin of each animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 h

Observation period:

8 d

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: left flank

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, residual test substance was removed by water.

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1 h, 24, 48 and 72 hrs and at 8 d

SCORING SYSTEM:
- Draize scale

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 8 d

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

not fully reversible within: 8 d

Remarks:

however, a tendency towards reversibility was noted

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 d

Score at time point / Reversibility	Erythema	Edema
Score at time point / Reversibility	Max. score: 4	Max. score: 4
60 min	1/0/1	3/1/2
24 h	1/0/1	2/2/1
48 h	1/0/0	1/2/1
72 h	0/0/0	1/1/1
0 d	Not recorded (reversible)	0/1/0
Average 24h, 48h, 72h	0.67/0/0.33	1.67/1.67/191.4%

Interpretation of results:

GHS criteria not met

Conclusions:

In this study, Isotridecyl Methacrylate is not a dermal irritant.

Executive summary:

In a primary dermal irritation study according to OECD guideline 404 (1981), 3 male young adult New Zealand White rabbits were dermally exposed to 0.5 g of Isotridecyl Methacrylate (91.4%) for 4 hours. Animals then were observed for 9 days. Irritation was scored by the method of Draize.

Very slight erythema was observed for up to 48 h. Slight to moderate edema was observed in all three animals. Grade 1 edema was still present after 8 d. However, as a tendency toward reversibility was noted, it is judged to be reversible.

In this study, Isotridecyl Methacrylate is not a dermal irritant.

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:

no adverse effect observed (not irritating)

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 24 Feb. 87

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, D- 4932 Extertal
- Age at study initiation: 10 weeks
- Housing: individually
- Diet (e.g. ad libitum): conventional laboratory diet (mümmel z, ssniff/Soest), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±2°C
- Humidity (%): 40 - 50%
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

24 h

Observation period (in vivo):

8 d

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after the 24 h observation, the corneas were examined with fluorescein

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: ophthalmoscope / fluorescein

Irritation parameter:

cornea opacity score

Basis:

animal: #1-3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal: #1-3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal: #1-3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

animal: #1-3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis	Discharge
Score at time point / Reversibility	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4	Max. score: 3
1 h	0/0/0	0/0/0	0/0/1	0/0/0	1/0/1
24 h	0/0/0	0/0/0	0/0/0	0/0/0	0/0/0
48 h	0/0/0	0/0/0	0/0/0	0/0/0	0/0/0
72 h	0/0/0	0/0/0	0/0/0	0/0/0	0/0/0
8 d	0/0/0	0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	0/0/0	0/0/0	0/0/0	0/0/0	0/0/0

Interpretation of results:

GHS criteria not met

Conclusions:

In this study, Isotridecyl Methacrylate is not irritating to the eyes.

Executive summary:

In a primary eye irritation study according to OECD Guideline 405 (1987) 0.1 mL of Isotridecyl Methacrylate (91.4%) was instilled into the conjunctival sac of the right eye of young adult New Zealand White rabbits. The eyes were rinsed after 24 h. Animals then were observed for 8 days. Irritation was scored by the method of Draize.

Grade 1 conjunctival redness was observed in 1/3 animals after 1 h, grade 1 discharge was observed in 2/3 animals after 1 h. No other reactions were noted.

In this study, Isotridecyl Methacrylate is not irritating to the eyes.

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:

no adverse effect observed (not irritating)

Endpoint conclusion:

no study available

Skin irritation

In a primary dermal irritation study according to OECD guideline 404 (1981), 3 male young adult New Zealand White rabbits were dermally exposed to 0.5 g of Isotridecyl Methacrylate (91.4%) for 4 hours. Animals then were observed for 9 days. Irritation was scored by the method of Draize.

Very slight erythema was observed for up to 48 h. Slight to moderate edema was observed in all three animals. Grade 1 edema was still present after 8 d. However, as a tendency toward reversibility was noted, it is judged to be reversible.

In this study, Isotridecyl Methacrylate is not a dermal irritant.

Eye irritation

In a primary eye irritation study according to OECD Guideline 405 (1987) 0.1 mL of Isotridecyl Methacrylate (91.4%) was instilled into the conjunctival sac of the right eye of young adult New Zealand White rabbits. The eyes were rinsed after 24 h. Animals then were observed for 8 days. Irritation was scored by the method of Draize.

Grade 1 conjunctival redness was observed in 1/3 animals after 1 h, grade 1 discharge was observed in 2/3 animals after 1 h. No other reactions were noted.

In this study, Isotridecyl Methacrylate is not irritating to the eyes.

Respiratory irritation

No data on the respiratory irritation of Isotridecyl Methacrylate are available.

There are no data gaps for the endpoint irritation/corrosion. No human information is available for this endpoint. However, there is no reason to believe that these results would not be applicable to humans.

Based on the available data, Isotridecyl Methacrylate does not need to be classified for eye irritation or skin irritation according to regulation (EC) 1272/2008. Thus, no labelling is required.