Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2011-10-19 to 2011-12-27
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Dermal irritation data recorded in the context of an acute dermal toxicity study with 2000 mg/kg bw. GLP.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: EU Method B.3 (Acute Toxicity (Dermal), adopted 30 May 2008
Deviations:
yes
Remarks:
3 animals were subject to reduced exposure time ranging between >4 to 24 hours
Qualifier:
according to guideline
Guideline:
other: OECD Guideline 402 (Acute Dermal Toxicity), adopted 24th Feb 1987
Deviations:
yes
Remarks:
3 animals were subject to reduced exposure time ranging between >4 to 24 hours
Principles of method if other than guideline:
Method: acute dermal toxicity test with full assessment of dermal irritation
GLP compliance:
yes (incl. QA statement)
Remarks:
Certificate dated 6 April 2009

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzyl methacrylate
EC Number:
219-674-4
EC Name:
Benzyl methacrylate
Cas Number:
2495-37-6
Molecular formula:
C11H12O2
IUPAC Name:
benzyl 2-methylprop-2-enoate
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Benzyl methacrylate

Test animals

Species:
rat
Strain:
Wistar
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- WISTAR rats Crl:WI(Han) (full barrier)
- Age at study initiation: males: approx. 13 weeks, females: approx. 14 weeks
- Weight at study initiation: males: 250-267 g, females: 205-223 g
- Fasting period before study: no
- Housing: separate IVC cages, type III H, polysulphone cages on Altromin saw figre bedding, full barrier in air-conditioned room
- Diet (e.g. ad libitum): Altromin 1324 maintenance diet for rats and mice, ad libitum
- Water (e.g. ad libitum): tap water, sulphur acidified to a pH value of approx. 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals), ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10/hr
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 2011-09-20 to 2011-11-10

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): n/a (undiluted)
Duration of treatment / exposure:
24 h (except for 3 test animals which unwrapped themselves overnight, leading to a shortened application period of 4 to 24 hours)
For the animals which unwrapped themselves, no signs of toxicity and significant dermal irritation were observed. As at the 4 h control observation the dressing was tight on all animals, it is very likely that the 3 animals unwrapped themselves clearly after the 4 h period. It can be expected that these animals have been exposed to the test item partially also by the oral route, while grooving, in addition to the dermal route.
As the normal exposure time in skin irrrittation studies according to the international guidelines does not exceed 4 hours, it is concluded that the abbreviated exposure period has no effect on the overall result and the classification of the test item, and that a sufficient estimation of the dermal irritation is ensured.
The validity of the study is not affected and according to animal welfare reasons it was decided not to repeat the study.
Observation period:
14 d
Number of animals:
5 per sex
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10
- Type of wrap if used: gauze-dressing with non-irritating tape, fixed with additional dressing in suitable manner.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): tap water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): n/a (undiluted)
- Constant volume or concentration used: yes (single dose)

OBSERVATIONS
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observation several times on day of dosing (at least once during first 30 minutes and with special attention given during the first 4 hours post-dose). Symptoms were recorded as soon as noticed. Thereafter, daily observations for clinical signs until end of observation period. All abnormalities were recorded. Animals were weighed on day 1 (prior to application of dose) and on day 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed:
-- In case of gross pathological changes, tissues were preserved for a possible histopathological evaluation.
-- The treated areas of skin were examined daily for signs of primary skin irritation. Signs of erythema and oedema were assessed using the scoring system laid down in OECD Guideline 404, adopted 24th April 2002.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
mean
Basis:
animal #2
Remarks:
female
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
erythema score
Remarks:
mean
Basis:
animal: #1, #3, #4, #5 female
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
mean
Basis:
animal: males 1-5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
mean
Basis:
animal: females 1-5, males 1-5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Other effects:
this study is described in detail in section 8.5.3 “Acute toxicity: dermal”

Any other information on results incl. tables

- very slight erythema (grade 1, reversible within 8 days) was observed in 1/5 females on days 4, 5, and 7; this animal showed also eschar (up to day 10) and desquamation (up to day 12)
- eschar, desquamation and scratches were observed in one further female, without leading to scoring
- all effects were reversible within 13 days
- females with reduced exposure time due to unwrapping showed either no effects or only non-scored eschar (day 5 to 7) or scratches (day 7)
- No skin irritation was observed at the males.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
In this acute dermal toxicity study in rat BNMA was found to be not irritating to the skin at a dose of 2000 mg/kg bw.
Executive summary:

In an acute dermal toxicity study according to OECD guideline 402 (24 Feb 1987), 5 female and 5 male Wistar rats were dermally exposed to BNMA at a concentration of 2000 mg/kg bw for 24 h to 10% body surface area. The test substance was removed by washing with tap water after 24 h.

Animals were observed for 14 days. Irritation was scored by the method given in OECD guideline 404 (24th April 2002).

In 1/5 females very slight erythema was observed, which was fully reversible within 8 days. All other animals showed no signs of dermal irritation.

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.