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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10-01-1989 - 17-01-1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted Feb 24, 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Cited as Directive 84/449/EEC, B.4
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Analytical purity: > 98%
- Lot/batch No.: 86013
- Expiration date of the lot/batch: Jan 30, 1989

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: New Zealand White, KFM (SPF-quality) Kleintierfarm Madoerin AG, Fuellinsdorf, Switzerland
- Age at study initiation: male: 14 weeks, females: 15 weeks
- Weight at study initiation: male: 2.6 kg, females: 2.5 - 2.8 kg
- Housing: in stainless steel cages
- Diet (e.g. ad libitum): pelleted standard Kliba 341, Batch 41/88 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 4 days under test conditions after veterinary examination


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3 °C
- Humidity (%): 40 - 70%
- Air changes (per hr): 10 - 15 air changes
- Photoperiod (hrs dark / hrs light): 12 hr artificial fluorescent light/ 12 hr dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: Diethylphthalate
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g/animal


VEHICLE
- Amount(s) applied (volume or weight with unit): the test substance was applied moistened with neantine
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approximately 100 cm² (10 cm x 10 cm)
- Type of wrap if used: elastic bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was flushed with lukewarm tap water
- Time after start of exposure: after 4 hr of application the test substance was removed


SCORING SYSTEM:
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beef redness) to eschar formation (injuries in depth): 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

Maximum cumulative score: 8 (erythema score: 4 and edema score: 4)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Application area: scars
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Irritation response of all 3 animals was below 2.3 and fully reversible within 7 days. Due erythema in 1/3 animals methacrylamide is considered to be slightly irritating to skin.

Any other information on results incl. tables

Results:

Coloration

In the area of application no staining of the treated skin by pigment or coloring of the test article was observed.

Corrosion

No destruction or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the treated skin.

Body weights

The body weight gain of all rabbits was similar.

Toxic symptoms / mortality

No acute toxic symptoms were observed in the animals during the test period, and no mortality occured.

Necropsy

No necropsy was performed. All animals were killed and discarded.

Skin irritation scores

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

60 min

2/1/1/

1/0/0/

24 h

2/1/1/ 

0/0/0/ 

48 h

2/0/1/ 

0/0/0/ 

72 h

2/0/1/ 

0/0/0/  

Average 24h, 48h, 72h

2/0.33/1/ 

0/0/0/ 

Reversibility*)

 c.

c. 

 

*) Reversibility: c. = completely reversible; = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Irritation response of all 3 animals was below 2.3 and fully reversible within 7 days. Due erythema in 1/3 animals methacrylamide is considered to be slightly irritating to skin.
Classification acc. EU CLP regulation 1272/2008: Not irritating to skin
Executive summary:

In a primary dermal irritation study (OECD 404) 1 male (14 weeks old) and 2 female (15 weeks old) New Zealand White rabbits were dermally exposed to 0.5 g of Methacrylamide (> 98 %) in diethylphthalate for 4 hours to 100 cm² of body surface area. Animals then were observed for 7 days. Irritation was scored by the method of EEC Council Directive 83/467/EEC, July 1983, Brussels. The study results were reevaluated acc. EU CLP regulation No 1272/2008. Irritation response of all 3 animals was below 2.3 and fully reversible within 7 days. Due erythema in 1/3 animals methacrylamide is considered to be slightly irritating to skin.

Classification acc. EU CLP regulation 1272/2008: Not irritating to skin