Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl methacrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

7 to 14 Oct 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl methacrylate

EC Number:

231-403-1

EC Name:

Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl methacrylate

Cas Number:

7534-94-3

Molecular formula:

C14H22O2

IUPAC Name:

1,7,7-trimethylbicyclo[2.2.1]hept-2-yl methacrylate

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): IBOMA Isobornyl methacrylate
- Physical state: Clear colourless liquid
- Storage condition of test material: Ambient temperature (10 °C to 30°C), protected from light
- Expiry date: November 04, 2017

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 to 16 weeks old
- Weight at study initiation: 2.49 - 2.70 kg
- Housing: in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 21 °C
- Humidity (%): 49 - 56 %
- Air changes (per hr): 15 changes per hour
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL undiluted test substance

Duration of treatment / exposure:

3 min, 1 hour and 4 hour(s)

Observation period:

24, 48, 72 hours and 7 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm²
- % coverage: no data availible
- Type of wrap if used: gauze patches, placed in position on the shorn skin, secured in position with strips of surgical adhesive tape, the trunk of each rabbit was wrapped in an elasticated corset
REMOVAL OF TEST SUBSTANCE
- Removal of the test substance by removal of the adhesive tape and the bandage. Residual test material was removed by gentle swabbing with cotton wool soaked with diethyl ether.
- Time after start of exposure: 24, 48 and 72 hours

SCORING SYSTEM: Draize JH (1959) scale
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

Oedema Formation
No oedema: 0
Very slight oedema (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:

primary dermal irritation index (PDII)

Remarks:

intact skin; evaluation of erythema and oedema

Basis:

mean

Remarks:

Classification according to Draize score (Draize JH, 1959)

Time point:

other: 24 and 72 hours

Score:

4

Max. score:

8

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Original data, evaluation according to Draize JH, 1959, moderate irritant No corrosive effects were noted. Crust formation was noted at all treated skin sites seven days after treatment.

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of 3 animals

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible

Remarks:

after 7 days

Remarks on result:

other: Evaluation according to Draize JH, 1959. No corrosive effects were noted. Crust formation was noted at all treated skin sites seven days after treatment.

Results 3

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of 3 animals

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Evaluation according to Draize JH, 1959. No corrosive effects were noted. Crust formation was noted at all treated skin sites seven days after treatment.

Any other information on results incl. tables

Classification of skin irritation studies according to OECD 404 / EU-GHS / UN-GHS criteria

Substance: Isobornyl methacylate        IBOMA        CAS: 7534 -94 -3

Internal No.: LITSU 11 -0007

Date/Expert: 09 June 2011/RG

Overall primary irritation score (PDII): 4 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  2  2  2  2      animal 2  2  2  2  2      animal 3  2  2  2  2      average (single scores: animal 1 -3) 2  2  2  2      Primary irritation index I = Mean erythema score  (Erythema; 24h, 72h);  out of 4 scores  2  Primary irritation index II =  Mean oedema score (Oedema; 24h, 72h);   out of 4 scores  2        Overall average PDII out of 8 scores; For evaluation according to GHS classification system:  4

 

Animal No.	Erythema/Eschar formation [Scores]				Mean Draize score (24 , 48, 72 h)	Oedema formation [Scores]				Mean Draize score	Hazard category EU-GHS	Hazard category UN-GHS
	24 h	48 h	72 h	7 days		24 h	48 h	72 h	7 days
1	2	2	2	0crust formation	2	2	2	2	0	2
2	2	2	2	0crust formation	2	2	2	2	0	2
3	2	2	2	0crust formation	2	2	2	2	0	2
					2					2	None	Cat. 3

 

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.     Category 2  (1) Mean value of >= 2.3 - < 4.0 for erythema/eschar or for oedema in at least 2 of 3 tested 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 persists 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 scaling; or (3) In some cases where there is pronounced variability of response among 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 - < 2.3 for erythema/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).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced well defined erythema and slight to
moderate oedema. Crust formation was noted at all treated skin sites seven days after treatment. The test material produced a primary irritation
index of 4.0 out of 8 and was classified as a moderate irritant to rabbit skin according to the Draize classificatiobn scheme. No corrosive effects were
noted.
According to EU Classification: not classified, no classification and labelling
According to GHS criteria UN category: 3

Executive summary:

In a primary dermal irritation study New Zealand White rabbits were dermally exposed (intact shaved skin, semi-occlusive) to 0.5 mL Isobornylmethacrylate for 4 hours. Animals then were observed for 7 days. Irritation was scored by the method of Draize et al, 1959. The mean erythema score (average value of the single scores (animals 1 -3; erythema; intact skin, 24h and 72h) was determined to be 2 out of 4 and, accordingly, the mean edema score 2 out of 4. 

The results demonstrate that Isobornylmethacrylate is not a dermal irritant according to EU-GHS criteria (EU-GHS-hazard category: none).

Remarks concerning the study result: The study for acute skin irritation/ corrosion was performed according to OECD 404. The results of the study were evaluated according to different evaluation-criteria (please see any other information on results inclusive tables).

EU-GHS Classification: not classified, no classification and labelling, According to GHS criteria UN category: 3 (mild irritant)

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