Isodecyl methacrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: OSHA Toxicity Screening Test. Limited documentation of the study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Guideline:

other: OSHA Toxicity Screening Test

Principles of method if other than guideline:

Draize Scoring

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isodecyl methacrylate

EC Number:

249-978-2

EC Name:

Isodecyl methacrylate

Cas Number:

29964-84-9

Molecular formula:

C14H26O2

IUPAC Name:

2-methylnonyl 2-methylprop-2-enoate

Details on test material:

2-Propenoic acid, 2-methyl-, isodecyl ester purity not specified, but commercial grade assumed.

Test animals

Species:

rabbit

Strain:

other: Albino

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: mean value 2,5 kg
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±1°C
- Humidity (%): 50 - 60 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Test system

Type of coverage:

not specified

Preparation of test site:

other: shaved and shaved/abraded

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

undiluted, 3000 mg/kg body weight

Duration of treatment / exposure:

no substance removal reported

Observation period:

24h and 72h post application and after 14 days

Number of animals:

6

Details on study design:

SCORING SYSTEM:
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Very severe erythema (beef redness) to eschar formation preventing grading of erythema: 4
Maximum possible: 4

Edema Formation
No edema: 0
Very slight edema (barely perceptible) : 1
Slight edem (edges of area well defined by definite raising):2
Moderate edema (raised approximately 1mm): 3
Severe edema (raised more than 1mm and extending beyond area of exposure):4
Maximum possible: 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #4

Time point:

other: mean 24 + 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: Occlusive, exposure during whole observation (not washed) , observation time 72 h, intact skin, reevaluated acc. CLP criteria

Results 2

Irritation parameter:

erythema score

Basis:

animal: #3, #5, #6

Time point:

other: mean 24 + 72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: Occlusive, exposure during whole observation (not washed) , observation time 72 h, intact skin, reevaluated acc. CLP criteria

Results 3

Irritation parameter:

edema score

Basis:

animal: #1, #2, #4

Time point:

other: mean 24 + 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: Occlusive, exposure during whole observation (not washed) , observation time 72 h, intact skin, reevaluated acc. CLP criteria

Results 4

Irritation parameter:

edema score

Basis:

animal: #3, #5, #6

Time point:

other: mean 24 + 72 hours

Score:

0.5

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: Occlusive, exposure during whole observation (not washed) , observation time 72 h, intact skin, reevaluated acc. CLP criteria

Results 5

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: avaraged score for 24 and 72 hrs; shaved skin

Results 6

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: avaraged score for 24 and 72 hrs; shaved skin

Results 7

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: avaraged score for 24 and 72 hrs; shaved skin

Results 8

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: avaraged score for 24 and 72 hrs; shaved skin

Results 9

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: avaraged score for 24 and 72 hrs; shaved skin

Results 10

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: avaraged score for 24 and 72 hrs; shaved skin

Any other information on results incl. tables

Isodecyl methacrylate, Skin irritation

Reevaluation acc. to CLP regulation, Skin irritation

Rohm & Haas 1973

Albino Rabbits

Coverage: not stated, shaved skin (results from scarified skin were regarded irrelevant)

Dosage: 3000 mg/kg, undiluted. No substance removal reported

Skin reactions

Animal Nr.	Erythema 24 h	Erythema 48 h	Erythema 72h	Mean Erythema	Edema 24 h	Edema 48 h	Edema 72 h	Mean Edema
1	0	-	0	0	0	-	0	0
2	0	-	0	0	0	-	0	0
3	2	-	2	2	1	-	0	0.5
4	0	-	0	0	0	-	0	0
5	2	-	2	2	1	-	0	0.5
6	2	-	2	2	1	-	0	0.5

 

Comparison with CLP criteria:

Remark: Exposure time was longer than 4 hours (during the whole observation time) and the observation time was only 72 hours.
All scores < 2.3. The highest mean erythema score is 2 for 3/6 animals, the highest edema score 0.5 for 3/6 animals..

Reversibility: no pathologic changes were noted 14 days after exposure.


Remarks concerning the study result: The study for acute skin irritation/  
corrosion was performed before OECD 404 came into force. For this reason the 
test values were reevaluated according to OECD criteria and test scores 
(erythema, oedema) obtained for the scarified skin were regarded as irrelevant.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Not irritating: Criteria used for interp not irritating: retation of results: other: CLP, EU, GHS (Regulation (EC) No 1272/2008)

Conclusions:

In an acute dermal toxicity study 3000mg/kg of undiluted test substance were applicated to the shaved and shaved/abradet skin of 6 albino rabbits. Skin was observed after 24 und 72 hours for irritating reactions. Skin reactions were reevaluated acc. CLP criteria.
All scores were < 2.3. The highest mean erythema score is 2 for 3/6 animals, the highest edema score 0.5 for 3/6 animals. As the exposure time is too short, it strictly cannot be excluded that the substance has a higher irritating potential but reversibility is supposable.

Executive summary:

In an acute dermal toxicity study 3000 mg/kg of undiluted test substance were applicated to the shaved and shaved/abradet skin of 6 albino rabbits. Skin was observed after 24 und 72 hours for irritating reactions. Skin reactions were reevaluated acc. CLP criteria.

All scores were < 2.3. The highest mean erythema score is 2 for 3/6 animals, the highest edema score 0.5 for 3/6 animals. As the observation time is too short, it strictly cannot be excluded that the substance has a higher irritating potential but reversibility is supposable, but it is assumable that the animals were exposed with the test substance during the whole observation time.

According CLP classification Isodecylmethacrylate is not irritating in this study.

Remarks concerning the study result: The study for acute skin irritation/corrosion was performed before OECD 404 came into force. For this reason the  test values were reevaluated according to CLP criteria and test scores  (erythema, oedema) obtained for the scarified skin were regarded as irrelevant.

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