2-Propenoic acid, 2-methyl-, C6-12-alkyl esters

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test procedure in accordance with national standard methods with acceptable restrictions. Restrictions: Observation period only 72 h, only two observations, duration of treatment 24 h instead of 4h.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)

Principles of method if other than guideline:

Method: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)
Information about the method, described in the study report ( Draize test: skin irritation/corrosion), is given in the free text field "methods and
materials".

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Decyl methacrylate

EC Number:

221-657-1

EC Name:

Decyl methacrylate

Cas Number:

3179-47-3

Molecular formula:

C14H26O2

IUPAC Name:

decyl 2-methylprop-2-enoate

Details on test material:

- Name of test material (as cited in study report): Decylmethacrylat, roh

Test animals

Species:

rabbit

Strain:

New Zealand White

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 °C
- Humidity (%): 45 - 55 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and shaved/abraded

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated skin areas of the test animals serve as the control (shaved, scarified).

Amount / concentration applied:

undiluted 0.5 mL

Duration of treatment / exposure:

24 hour(s)

Observation period:

24h and 72h post application

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100% the whole animal was covered with a gummed bandage
- Type of wrap if used: gummed bandage to wrap up the body of the test animal.
REMOVAL OF TEST SUBSTANCE
- Removal of the test substance by removal of the adhesive tape and the bandage, no wash off

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:

mean

Time point:

other: 24 and 72 hours

Score:

1.67

Max. score:

4

Reversibility:

no data

Remarks on result:

other: No data in respect to reversibilty for times after exposure > 72h. Only data of shaved skin have been used, data of shaved and scarified skin have not been used.

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0.92

Max. score:

4

Reversibility:

no data

Remarks on result:

other: No data in respect to reversibilty for times after exposure > 72h. Only data of shaved skin have been used, data of shaved and scarified skin have not been used.

Any other information on results incl. tables

Overall primary irritation score (PDII): 2.6 of 8 scores FDA (Draize), 1959,  

re-evaluated according to OECD 404

Reevaluation of the test results according to OECD404/GHS: only records for the shaved skin (not scarified) were considered  Erythema/ 24h     Erythema/72h  Oedema/24h  Oedema/72h  animal 1  1  2  1  1  animal 2  2  2  1  1  animal 3  1  2  1  1  animal 4  1  2  1  1  animal 5  2  2  1  1  animal 6  1  2  0  1  average (single scores: animal 1-6)  1,333 2,0  0,833  1,0  Primary irritation index I = Mean erythema score  (Erythema; 24h, 72h);  out of 4 scores  1,667  Primary irritation index II =  Mean oedema score (Oedema; 24h, 72h);   out of 4 scores  0,9167    Overall average PDII out of 8 scores; For evaluation according to GHS classification system:  2,6

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.

  
Classification criteria according to the different classification systems:

EU-GHS:

Category 1: Corrosive subcategories

Corrosive in >= 1 of 3 animals
(applies to authorities not using subcategories): Corrosive
(only applies to some authorities)

Subcategory    Exposure                       Observation
------------------------------------------------------------
1A             <= 3 minutes                   <= 1 hour
1B             > 3 minutes to <= 1 hour       <= 14 days
1C             > 1 hour to <= 4 hours         <= 14 days
------------------------------------------------------------

A: Single harmonized corrosion category, using the results of animal testing.
A: Corrosive is a test substance that produces destruction of skin tissue, namely, 
visible necrosis through the epidermis and into the dermis, in at least 1 of 3 
tested animals after exposure up to 4 hours duration. Corrosive reactions are 
typified by ulcers, bleeding, bloody scrabs and, by the end of observation at 14 
days, by discoloration due to bleaching of the skin, complete areas of alopecia 
and scars. Histopathologic determinations should be consided evaluate questionable 
lesions.

Substances and/or mixtures are considered corrosive (Skin categorry 1) if it has
a pH of 2 or less or a pH of 11.5 or greater. If consideration of alkali/acid 
reserve suggests the substance or prepatration may not be corrosive despite the 
low or high pH value, then further testing needs to be carried out to confirm 
this, preferably by use of an appropriate validated in vitro test.

Category 2:

(1) Mean value of >= 2.3 to < 4.0 for erythem/eschar or for oedema in at least 2 
    of 3 animals from gradings at 24, 48 and 72 hours after patch removal or, if 
    reactions are delayed, from grades on 3 consecutive days after the onset of 
    skin reactions, or
(2) Inflammation that persits to the end of the observation period normally 14
    days in at least 2 animals, particularly taking into account alopecia 
    (limited area), hyperkeratosis, hyperplasia, and scalling, or
(3) In some cases where there is pronounced variability of response amoung 
    animals, with very definite positive effects related to chemical exposure
    in a single animal but less than the criteria above.

UN-GHS (additional category 3):

Category 3: Mild irritant (Applies to only some authorities for e.g. UN-GHS)

Mean value of >= 1.5 to < 2.3 for erythem/eschar or for oedema from gradings
in at least 2 of 3 tested animals from grades at 24, 48 and 72 hours or, if
reactions are delayed, from grades on 3 consecutive days after the onset of
skin reactions (when not included in the irritant category above).

According to the results of this dermal irritation study n-Decylmethacrylate
has to be classified as follows:

According to GefStoffV: slightly below the irritancy threshold (non-irritant, 
                        but 24 hour exposition, no wash off the test substance)
According to EU-GHS (CLP): Hazard category: None (effects < 2.3 both erythem 
                        and oedema)
According to UN-GHS: Hazard category: 3 (Erythem > 1.5 but < 2.3, 24 hour 
                        exposition, no wash off the test substance)











   
    
    
    
    
    
    
    
    
    

ems:






























 
  
  
  
  
  
  
  
  
  
  

Classification criteria according to the different classification systems:































    
    
  










Classification criteria according to the different classification systems:




































    
  











Classification criteria according to the different classification systems:






































  












 



















































EU-GHS:



















































Category 1: Corrosive subcategories



















































  



















































Corrosive in >= 1 of 3 animals



















































(applies to authorities not using subcategories): Corrosive



















































(only applies to some authorities)



















































Subcat. Exposure                          Observation



















































1A    <= 3 minutes                      <= 1 hour



















































1B     > 3 minutes -- <= 1 hour  <= 14 days



















































1C     > 1 hour -- <= 4 hours      <= 14 days



















































A single harmonized corrosion category is provided in Table 3.2.1, using the results of animal



















































testing. A corrosive is a test material that produces destruction of skin tissue, namely, visible necrosis



















































through the epidermis and into the dermis, in at least 1 of 3 tested animals after exposure up to a 4 hour



















































duration. Corrosive reactions are typified by ulcers, bleeding, bloody scabs and, by the end of observation at



















































14 days, by discoloration due to blanching of the skin, complete areas of alopecia and scars. Histopathology



















































should be considered to discern questionable lesions.



















































 



















































A mixture is considered corrosive (Skin Category 1) if it has a pH of 2 or less or a pH of 11.5 or greater. If



















































consideration of alkali/acid reserve suggests the substance or preparation may not be corrosive despite the low or high pH value, then further testing needs to be carried out to confirm this, preferably by use of an appropriate validated in vitro test.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

n-Decyl methacrylate was slightly irritating in a primary skin irritation study in rabbits (24-hour occlusive application, no wash of the
test substance). No data in respect to reversibilty for times after > 72h observation. Only data of shaved skin have been used, data of shaved and
scarified skin have not been used.
According to the results of this dermal irritation study n-Decylmethacrylate has to be classified as follows:
According to GefStoffV: slightly below the irritancy threshold (non-irritant, but 24 hour application, no wash off the test substance)
According to EU-GHS (CLP): Hazard category: None (effects < 2.3 both erythem and oedema)
According to UN-GHS: Hazard category: 3 (Erythem > 1.5 but < 2.3, 24 hour application, no wash off the test substance) slightly irritating

Executive summary:

In a primary dermal irritation study New Zealand White rabbits were dermally exposed (intact and scarified skin) to

0.5 mL undiluted n-Decyl methacrylate for 24 hours. Animals then were observed for 3 days. Irritation was scored by the method of Draize et al, 1959.

The mean erythema score (average value of  the single scores (animals 1-6; erythema; intact skin, 24h and 72h)  was determined to be 1.667 out of 4 and the mean edema score was 0.9167 out of 4.   

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. According to the results of this dermal irritation study n-Decylmethacrylate has to be classified as follows: According to GefStoffV: slightly below the irritancy threshold (non-irritant, but 24 hour application, no wash off the test substance) According to EU-GHS (CLP): Hazard category: None (effects < 2.3 both erythem and oedema) According to UN-GHS: Hazard category: 3 (Erythem > 1.5 but < 2.3, 24 hour application, no wash off the test substance) mildly irritating 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.