Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
02.11.2011-27.12.2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Gudeline study OECD 402, GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
2009-04-06
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[2-(2-ethoxyethoxy)ethoxy]ethyl methacrylate
EC Number:
254-588-0
EC Name:
2-[2-(2-ethoxyethoxy)ethoxy]ethyl methacrylate
Cas Number:
39670-09-2
Molecular formula:
C12H22O5
IUPAC Name:
2-[2-(2-ethoxyethoxy)ethoxy]ethyl methacrylate
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Ethyltriglycol methacrylate
- Substance type: organic
- Physical state: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: WISTAR rats Cr!: WI(Han) (full baITier)
- Number of animals: 5 male and 5 female
- Age at study initiation: males: approximately 9 weeks old, females: approximately 13 weeks old
- Weight at study initiation: males: 236 - 249 g; females: 208 - 220 g.
- Fasting period before study: no
- Housing: separately in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding. Full barrier in an 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 approximately 2,8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: at least five days

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area of the trunk, approx. 10 % of the total body surface
- Type of wrap if used: gauze-dressing with non-irritating tape, fixed with additional dressing in suitable manner.

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

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)
Duration of exposure:
24 hours
Doses:
Single dose of 2000 mg/kg body weight to each anima!.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- 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

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: mortality 0/10 Limit test according to OECD 402.
Mortality:
No mortality observed. All animals survived until the end of the observation period of 14 days.
Clinical signs:
No signs of systemic toxicity were observed.
The nasal discharge observed 1 day post-dose in one female animal is not considered to be related to the test item, but to the administration
procedure and the possible stress induced.
No signs of skin irritation were observed.
Body weight:
A slight weight loss was recorded for 1 of 5 female animals during the first week, but all of the female animals showed weight gain during the
second week, The effects on weight development might be secondary to the dressing, and toxicological relevance of this finding cannot clearly be concluded.
The male animals showed weight gain during the first and the second week of the observation.
Gross pathology:
With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal.
Other findings:
No skin irritation was observed at the males and females.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
The LD50-value for acute dermal toxicity of the test substance Ethyltriglycol methacrylate is > 2000 mg/kg bw.
Executive summary:

In an acute dermal toxicity study according to OECD guideline 402 (adopted 24th Feb, 1987), EU Method B.3 (adopted 30 May 2008), 5 male and 5 female young adult WISTAR Crl: WI(Han) rats were dermally exposed to Ethyltriglycol methacrylate (98.95%) for 24 hours unter a semiocclusive dressing to approx. 10% of body surface area at doses of 2000 mg/kg bw. Animals then were observed for 14 days.

No animal died. No signs of skin irritation were observed. No clinical signs of systemic toxicity were observed. A slight weight loss was recorded for 1 of 5 female animals during the first week, but all of the female animals showed weight gain during the second week,

The male animals showed weight gain during the first and the second week of the observation. No macroscopic substance related pathologic organ findings were noted during necropsy.

Dermal LD50

Males > 2000  mg/kg bw

Females > 2000  mg/kg bw

Combined > 2000  mg/kg bw

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